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Konsolidirano besedilo: Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini Dostop do prvotnega pravnega akta ( V veljavi ) 01/01/2025 ELI: http://data.europa.eu/eli/dir/2001/83/2025-01-01	Consolidated text: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use Access initial legal act ( In force ) 01/01/2025 ELI: http://data.europa.eu/eli/dir/2001/83/2025-01-01

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Datum dokumenta: 01/01/2025 Datum začetka učinkovanja: 01/01/2025	Date of document: 01/01/2025 Date of effect: 01/01/2025

Drugi podatki	Miscellaneous information
Avtor: Ni na voljo Pravna oblika: Konsolidirano besedilo	Author: Not available Form: Consolidated text

Besedilo	Text

02001L0083 — SL — 01.01.2025 — 016.001	02001L0083 — EN — 01.01.2025 — 016.001
To besedilo je zgolj informativne narave in nima pravnega učinka. Institucije Unije za njegovo vsebino ne prevzemajo nobene odgovornosti. Verodostojne različice zadevnih aktov, vključno z uvodnimi izjavami, so objavljene v Uradnem listu Evropske unije. Na voljo so na portalu EUR-Lex. Uradna besedila so neposredno dostopna prek povezav v tem dokumentu	This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
►B \| DIREKTIVA 2001/83/ES EVROPSKEGA PARLAMENTA IN SVETA \| z dne 6. novembra 2001 \| o zakoniku Skupnosti o zdravilih za uporabo v humani medicini \| (UL L 311 28.11.2001, str. 67)	►B \| DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL \| of 6 November 2001 \| on the Community code relating to medicinal products for human use \| (OJ L 311 28.11.2001, p. 67)
spremenjena z:	Amended by:
\| \| Uradni list	\| \| Official Journal
št. \| stran \| datum	No \| page \| date
►M1 \| DIREKTIVA EVROPSKEGA PARLAMENTA IN SVETA 2002/98/ES z dne 27. januarja 2003 \| L 33 \| 30 \| 8.2.2003	►M1 \| DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003 \| L 33 \| 30 \| 8.2.2003
►M2 \| DIREKTIVA KOMISIJE 2003/63/ES z dne 25. junija 2003 \| L 159 \| 46 \| 27.6.2003	►M2 \| COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 \| L 159 \| 46 \| 27.6.2003
►M3 \| DIREKTIVA 2004/24/ES EVROPSKEGA PARLAMENTA IN SVETA z dne 31. marca 2004 \| L 136 \| 85 \| 30.4.2004	►M3 \| DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 \| L 136 \| 85 \| 30.4.2004
►M4 \| DIREKTIVA 2004/27/ES EVROPSKEGA PARLAMENTA IN SVETA z dne 31. marca 2004 \| L 136 \| 34 \| 30.4.2004	►M4 \| DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 \| L 136 \| 34 \| 30.4.2004
►M5 \| UREDBA (ES) št. 1901/2006 EVROPSKEGA PARLAMENTA IN SVETA z dne 12. decembra 2006 \| L 378 \| 1 \| 27.12.2006	►M5 \| REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 \| L 378 \| 1 \| 27.12.2006
►M6 \| UREDBA (ES) št. 1394/2007 EVROPSKEGA PARLAMENTA IN SVETA z dne 13. novembra 2007 \| L 324 \| 121 \| 10.12.2007	►M6 \| REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 \| L 324 \| 121 \| 10.12.2007
►M7 \| DIREKTIVA 2008/29/ES EVROPSKEGA PARLAMENTA IN SVETA z dne 11. marca 2008 \| L 81 \| 51 \| 20.3.2008	►M7 \| DIRECTIVE 2008/29/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 \| L 81 \| 51 \| 20.3.2008
►M8 \| DIREKTIVA 2009/53/ES EVROPSKEGA PARLAMENTA IN SVETA z dne 18. junija 2009 \| L 168 \| 33 \| 30.6.2009	►M8 \| DIRECTIVE 2009/53/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 \| L 168 \| 33 \| 30.6.2009
►M9 \| DIREKTIVA KOMISIJE 2009/120/ES z dne 14. septembra 2009 \| L 242 \| 3 \| 15.9.2009	►M9 \| COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 \| L 242 \| 3 \| 15.9.2009
►M10 \| DIREKTIVA 2010/84/EU EVROPSKEGA PARLAMENTA IN SVETA z dne 15. decembra 2010 \| L 348 \| 74 \| 31.12.2010	►M10 \| DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 \| L 348 \| 74 \| 31.12.2010
►M11 \| DIREKTIVA 2011/62/EU EVROPSKEGA PARLAMENTA IN SVETA z dne 8. junija 2011 \| L 174 \| 74 \| 1.7.2011	►M11 \| DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 \| L 174 \| 74 \| 1.7.2011
►M12 \| DIREKTIVA 2012/26/EU EVROPSKEGA PARLAMENTA IN SVETA z dne 25. oktobra 2012 \| L 299 \| 1 \| 27.10.2012	►M12 \| DIRECTIVE 2012/26/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 \| L 299 \| 1 \| 27.10.2012
►M13 \| UREDBA (EU) 2017/745 EVROPSKEGA PARLAMENTA IN SVETA z dne 5. aprila 2017 \| L 117 \| 1 \| 5.5.2017	►M13 \| REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 \| L 117 \| 1 \| 5.5.2017
►M14 \| UREDBA (EU) 2019/5 EVROPSKEGA PARLAMENTA IN SVETA z dne 11. decembra 2018 \| L 4 \| 24 \| 7.1.2019	►M14 \| REGULATION (EU) 2019/5 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 \| L 4 \| 24 \| 7.1.2019
►M15 \| UREDBA (EU) 2019/1243 EVROPSKEGA PARLAMENTA IN SVETA z dne 20. junija 2019 \| L 198 \| 241 \| 25.7.2019	►M15 \| REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 \| L 198 \| 241 \| 25.7.2019
►M16 \| DIREKTIVA (EU) 2022/642 EVROPSKEGA PARLAMENTA IN SVETA z dne 12. aprila 2022 \| L 118 \| 4 \| 20.4.2022	►M16 \| DIRECTIVE (EU) 2022/642 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 April 2022 \| L 118 \| 4 \| 20.4.2022
►M17 \| UREDBA (EU) 2023/1182 EVROPSKEGA PARLAMENTA IN SVETA z dne 14. junija 2023 \| L 157 \| 1 \| 20.6.2023	►M17 \| REGULATION (EU) 2023/1182 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2023 \| L 157 \| 1 \| 20.6.2023
popravljena z:	Corrected by:
►C1 \| Popravek, UL L 087, 31.3.2009, str. 174 (1394/2007)	►C1 \| Corrigendum, OJ L 087, 31.3.2009, p. 174 (1394/2007)
►C2 \| Popravek, UL L 276, 21.10.2011, str. 63 (2010/84/EU)	►C2 \| Corrigendum, OJ L 276, 21.10.2011, p. 63 (2010/84/EU)
►C3 \| Popravek, UL L 238, 9.8.2014, str. 31 (2011/62/ES)	▼B
▼B	DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
DIREKTIVA 2001/83/ES EVROPSKEGA PARLAMENTA IN SVETA	of 6 November 2001
z dne 6. novembra 2001	on the Community code relating to medicinal products for human use
o zakoniku Skupnosti o zdravilih za uporabo v humani medicini	TITLE I
NASLOV 1	DEFINITIONS
OPREDELITVE POJMOV	Article 1
Člen 1	For the purposes of this Directive, the following terms shall bear the following meanings:
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2. \| Zdravilo : \| (a) \| Vsaka snov ali kombinacija snovi, ki so predstavljene z lastnostmi za zdravljenje ali preprečevanje bolezni pri ljudeh; ali \| (b) \| Vsaka snov ali kombinacija snovi, ki se lahko uporablja pri ali daje ljudem za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek farmakološkega, imunološkega ali presnovnega delovanja, ali za določitev diagnoze.	2. \| Medicinal product : \| (a) \| Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or \| (b) \| Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
▼B	▼B
3. \| Snov : \| Vsaka snov, ne glede na izvor, ki je lahko: \| — \| človeškega izvora, npr. \| človeška kri in človeški krvni izdelki, \| — \| živalskega izvora, npr. \| mikroorganizmi, cele živali, deli organov, živalski izločki, strupi, izvlečki, krvni izdelki, \| — \| rastlinskega izvora, npr. \| mikroorganizmi, rastline, deli rastlin, rastlinski izločki, izvlečki, \| — \| kemičnega izvora, npr. \| elementi, kemične snovi, ki se pojavljajo v določeni obliki v naravi, kemični izdelki, pridobljeni s kemično spremembo ali sintezo.	3. \| Substance : \| Any matter irrespective of origin which may be: \| — \| human, e.g. \| human blood and human blood products; \| — \| animal, e.g. \| micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; \| — \| vegetable, e.g. \| micro-organisms, plants, parts of plants, vegetable secretions, extracts; \| — \| chemical, e.g. \| elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
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3a. \| Zdravilna učinkovina : Vsaka snov ali mešanica snovi, namenjena uporabi v proizvodnji zdravil, ki z uporabo v proizvodnji zdravila postane njegova zdravilna učinkovina, katere namen je farmakološko, imunološko ali presnovno delovanje, da bi se ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije ali da bi se določila diagnoza.	3a. \| Active substance : Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
3b. \| Pomožna snov : Vsaka sestavina zdravila, ki ni zdravilna učinkovina ali ovojnina.	3b. \| Excipient : Any constituent of a medicinal product other than the active substance and the packaging material.
▼B	▼B
4. \| Imunološka zdravila : \| Vsa zdravila, ki obsegajo cepiva, toksine, serume ali alergene: \| (a) \| cepiva, toksini in serumi zajemajo zlasti: \| (i) \| učinkovine, ki so sposobne izzvati aktivno imunost, kot npr. cepivo proti koleri, BCG, cepiva proti poliomielitisu, cepivo proti črnim kozam; \| (ii) \| učinkovine, ki se uporabljajo za diagnosticiranje stanja imunosti, vključno zlasti s tuberkulinom in tuberkulinom PPD, toksini za Schickov in Dickov test, brucelin; \| (iii) \| učinkovine, ki so sposobne izzvati pasivno imunost, kot npr. antitoksin za davico, globulin proti črnim kozam, antilimfocitni globulin; \| (b) \| „alergen“ je vsako zdravilo, ki je namenjeno za določitev ali sproženje specifične pridobljene spremembe v imunološkem odzivu na alergen.	4. \| Immunological medicinal product : \| Any medicinal product consisting of vaccines, toxins, serums or allergen products: \| (a) \| vaccines, toxins and serums shall cover in particular: \| (i) \| agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine; \| (ii) \| agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin; \| (iii) \| agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin; \| (b) \| ‘allergen product’ shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
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4a. \| Zdravilo za napredno zdravljenje : Izdelek, kakor je opredeljen v členu 2 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje ( 1 ).	4a. \| Advanced therapy medicinal product : A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products ( 1 ).
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5. \| Homeopatsko zdravilo : Vsako zdravilo, pripravljeno iz snovi, ki se imenujejo homeopatske surovine, v skladu s homeopatskim postopkom izdelave po določilih Evropske farmakopeje, ali v odsotnosti teh, po drugih farmakopejah, ki se uradno uporabljajo v državah članicah. Homeopatsko zdravilo lahko vsebuje več učinkovin.	5. \| Homeopathic medicinal product : Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles.
▼B	▼B
6. \| Radiofarmacevtski izdelek : Vsak izdelek, ki vsebuje, takrat ko je pripravljen za uporabo, enega ali več radionuklidov (radioaktivnih izotopov), namenjenih medicinski uporabi.	6. \| Radiopharmaceutical : Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose.
7. \| Radionuklidni generator : Vsak sistem z vgrajenim trdo vezanim starševskim radionuklidom, iz katerega nastane hčerinski radionuklid, ki se pridobiva z eluiranjem ali drugo metodo in se uporablja v radiofarmacevtskem izdelku.	7. \| Radionuclide generator : Any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical.
8. \| ►M4 Komplet ◄ : Vsak pripravek, ki ga rekonstituiramo ali kombiniramo z radionuklidi v končnem radiofarmacevtskem izdelku, običajno pred dajanjem bolniku.	8. \| ►M4 Kit ◄ : Any preparation to be reconsitituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration.
9. \| Radionuklidni predhodnik : Vsak drug radionuklid, pripravljen za označevanje sevanja druge snovi pred dajanjem bolniku.	9. \| Radionuclide precursor : Any other radionuclide produced for the radio-labelling of another substance prior to administration.
10. \| Zdravila, izdelana iz človeške krvi ali človeške plazme : Vsa zdravila, izdelana iz sestavin krvi, ki jih industrijsko izdelujejo javne ali zasebne ustanove, kot npr. zdravila, ki vključujejo zlasti albumin, koagulacijske faktorje in imunoglobuline človeškega izvora.	10. \| Medicinal products derived from human blood or human plasma : Medicinal products based on blood constitutents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.
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11. \| Neželeni učinek : Odziv na zdravilo, ki je škodljiv in nenameren.	11. \| Adverse reaction : A response to a medicinal product which is noxious and unintended.
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12. \| Resen neželen učinek : Neželena reakcija, ki ima za posledico smrt, neposredno življenjsko ogroženost, zahteva bolnišnično zdravljenje ali podaljšanje obstoječega bolnišničnega zdravljenja, ima za posledico dolgotrajno ali izrazito nezmožnost ali nesposobnost, ali pa prirojeno anomalijo/prirojeno napako.	12. \| Serious adverse reaction : An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
13. \| Nepričakovan neželen učinek : Neželena reakcija, katere vrsta, resnost ali izid ni skladna s povzetkom glavnih značilnosti zdravila.	13. \| Unexpected adverse reaction : An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.
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15. \| Študija o varnosti zdravila po pridobitvi dovoljenja za promet : Vsaka študija o zdravilu, ki je pridobilo dovoljenje za promet, katere cilj je ugotovitev, opredelitev značilnosti ali količinska določitev tveganja, ki potrjuje varnostne lastnosti zdravila, ali merjenje učinkovitosti ukrepov za obvladovanje tveganj.	15. \| Post-authorisation safety study : Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.
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16. \| Zloraba zdravil : Trajna ali posamezna namerna prekomerna uporaba zdravil, ki jo spremljajo škodljivi fizični ali psihološki učinki.	16. \| Abuse of medicinal products : Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effets.
17. \| Promet z zdravili na debelo : Za promet z zdravili na debelo se šteje nakup zdravil, hramba ter prodaja ali izvoz zdravil, razen izdajanja zdravil širši javnosti. Promet z zdravili na debelo opravljajo proizvajalci ali njihovi depozitarji, uvozniki, drugi trgovci ali pa ga opravljajo farmacevti in osebe, ki imajo v zadevni državi članici dovoljenje za izdajanje zdravil širši javnosti.	17. \| Wholesale distribution of medicinal products : All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.
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17a. \| Posredovanje zdravil : Vse dejavnosti, ki so povezane s prodajo ali nabavo zdravil, razen prometa na debelo, ki ne vključujejo stika z zdravilom in predstavljajo neodvisno posredovanje v imenu druge pravne ali fizične osebe.	17a. \| Brokering of medicinal products : All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.
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18. \| Obveznost javnih storitev : Obveznost veletrgovcev, da zagotavljajo stalen in ustrezen izbor zdravil, s katerim zadoščajo zahtevam določenega geografskega območja in v zelo kratkem času dostavljajo zahtevane dobave celotnemu zadevnemu območju.	18. \| Public service obligation : The obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
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18a. \| Predstavnik imetnika dovoljenja za promet z zdravilom : Oseba, običajno lokalni predstavnik, ki ga imetnik dovoljenja za promet z zdravilom imenuje za svojega predstavnika v zadevni državi članici.	18a \| Representative of the marketing authorisation holder : The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned.
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19. \| Zdravniški recept : Vsak recept, ki ga izda strokovna, za to usposobljena oseba.	19. \| Medicinal Prescription : Any medicinal prescription issued by a professional person qualified to do so.
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20. \| Ime zdravila : Ime zdravila, ki je lahko izmišljeno ime, ki ne sme povzročati zamenjave s splošnim imenom, ali splošno ali znanstveno ime skupaj z blagovno znamko ali imenom imetnika dovoljenja za promet z zdravilom.	20. \| Name of the medicinal product : The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.
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21. \| Splošno ime : Mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, ali če tega imena ni, običajno splošno ime.	21. \| Common name : The international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name.
22. \| Jakost zdravila : Vsebnost zdravilnih učinkovin, izražena količinsko na enoto odmerka, na enoto prostornine ali mase, skladno s farmacevtsko obliko.	22. \| Strength of the medicinal product : The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.
23. \| Stična ovojnina : Vsebnik ali druga oblika ovojnine, ki je neposredno v stiku z zdravilom.	23. \| Immediate packaging : The container or other form of packaging immediately in contact with the medicinal product.
24. \| Zunanja ovojnina : Ovojnina, v katero je vložena stična ovojnina.	24. \| Outer packaging : The packaging into which is placed the immediate packaging.
25. \| Označevanje : Podatki na stični ali zunanji ovojnini.	25. \| Labelling : Information on the immediate or outer packaging.
26. \| Navodilo za uporabo : Zdravilu priložen listič s podatki, namenjenimi uporabniku.	26. \| Package leaflet : A leaflet containing information for the user which accompanies the medicinal product.
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26a. \| Sprememba ali sprememba pogojev za dovoljenje za promet z zdravilom : \| Sprememba vsebine podatkov in dokumentov iz: \| (a) \| člena 8(3) in členov 9 do 11 te direktive in Priloge I k tej direktivi, člena 6(2) Uredbe (ES) št. 726/2004 in člena 7 Uredbe (ES) št. 1394/2007 ter \| (b) \| pogojev sklepa o izdaji dovoljenja za promet z zdravilom za uporabo v humani medicini, vključno s povzetkom glavnih značilnosti zdravila, in katerih koli pogojev, obveznosti ali omejitev, ki vplivajo na dovoljenje za promet, ali sprememb označevanja ali navodila za uporabo, povezanih s spremembami povzetka glavnih značilnosti zdravila.	26a. \| Variation or variation to the terms of a marketing authorisation : \| An amendment to the contents of the particulars and documents referred to in: \| (a) \| Article 8(3) and Articles 9 to 11 of this Directive and Annex I thereto, Article 6(2) of Regulation (EC) No 726/2004 and in Article 7 of Regulation (EC) No 1394/2007; and \| (b) \| the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet related to changes to the summary of the product characteristics.
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27. \| Agencija : Evropska agencija za zdravila, ustanovljena z Uredbo (ES) št. 726/2004 ( 2 ).	27. \| Agency : The European Medicines Agency established by Regulation (EC) No 726/2004 ( 2 ).
28. \| Tveganje, povezano z uporabo zdravila : \| — \| vsako tveganje za zdravje bolnika ali javno zdravje, ki je povezano s kakovostjo, varnostjo ali učinkovitostjo zdravila; \| — \| vsako tveganje neželenih vplivov na okolje.	28. \| Risks related to use of the medicinal product : \| — \| any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health; \| — \| any risk of undesirable effects on the environment.
28a. \| Razmerje med tveganji in koristmi : Ocena pozitivnih terapevtskih učinkov zdravila glede na tveganje, kot je določeno v prvi alinei točke 28.	28a. \| Risk-benefit balance : An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28, first indent.
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28b. \| Sistem obvladovanja tveganj : Sklop dejavnosti farmakovigilance in posegov za ugotovitev, opredelitev značilnosti, preprečevanje ali zmanjševanje tveganj v zvezi z zdravilom, vključno z oceno učinkovitosti navedenih dejavnosti in posegov.	28b. \| Risk management system : a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions.
28c. \| Načrt za obvladovanje tveganj : Natančen opis sistema obvladovanja tveganj.	28c. \| Risk management plan : a detailed description of the risk management system.
28d. \| Sistem farmakovigilance : Sistem spremljanja in poročanja, ki ga uporabljajo imetniki dovoljenja za promet in države članice za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX in katerega namen je spremljati zdravila, ki so pridobila dovoljenje za promet, in odkrivanje sprememb razmerja med tveganjem in koristjo zdravil.	28d. \| Pharmacovigilance system : a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
28e. \| Glavni dosje o sistemu farmakovigilance : Podroben opis sistema farmakovigilance, ki ga uporabljajo imetniki dovoljenj za promet glede enega ali več zdravil, ki so pridobila dovoljenje za promet.	28e. \| Pharmacovigilance system master file : A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.
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29. \| Tradicionalno zdravilo rastlinskega izvora : Zdravilo rastlinskega izvora, ki izpolnjuje pogoje, določene v členu 16a(1).	29. \| Traditional herbal medicinal product : A herbal medicinal product that fulfils the conditions laid down in Article 16a(1).
30. \| Zdravilo rastlinskega izvora : Katero koli zdravilo, ki kot učinkovine vsebuje izključno eno ali več rastlinskih snovi, enega ali več rastlinskih pripravkov, ali eno ali več takih rastlinskih snovi v kombinaciji z enim ali več takimi rastlinskimi pripravki.	30. \| Herbal medicinal product : Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.
31. \| Rastlinske snovi : Vse pretežno cele, razdrobljene ali razrezane rastline, deli rastlin, alge, glive, lišaji v neobdelanem stanju, običajno so posušene, včasih tudi sveže. Nekatere izločke, ki niso posebej obdelani, tudi štejejo za rastlinske snovi. Rastlinske snovi so natančno opredeljene z delom rastline, ki se uporablja in latinskim imenom v skladu z binominalnim sistemom (rod, vrsta, varieteta in avtor).	31. \| Herbal substances : All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author).
32. \| Pripravki rastlinskega izvora : Pripravki, pridobljeni z obdelavo rastlinskih snovi, kot so ekstrakcija, destilacija, stiskanje, frakcioniranje, prečiščevanje, koncentriranje ali fermentacija. To vključuje zdrobljene ali uprašene rastlinske snovi, tinkture, ekstrakte, eterična olja, iztisnjene sokove in pridobljene izločke.	32. \| Herbal preparations : Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.
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33. \| Ponarejeno zdravilo : \| Vsako zdravilo, ki lažno predstavlja: \| (a) \| svojo istovetnost, vključno z ovojnino in oznako, imenom ali sestavo glede katere koli od svojih sestavin, vključno s pomožnimi snovmi, in jakostjo teh sestavin; \| (b) \| svoj izvor, vključno s proizvajalcem, državo proizvodnje, državo izvora ali imetnikom dovoljenja za promet z njim, ali \| (c) \| svojo zgodovino, vključno z zapisi in dokumentacijo o uporabljenih distribucijskih poteh. \| Ta opredelitev ne zajema nenamernih napak v kakovosti in ne posega v kršitve pravic intelektualne lastnine.	33. \| Falsified medicinal product : \| Any medicinal product with a false representation of: \| (a) \| its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; \| (b) \| its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or \| (c) \| its history, including the records and documents relating to the distribution channels used. \| This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.
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NASLOV II	TITLE II
OBSEG	SCOPE
▼M4	▼M4
Člen 2	Article 2
1.	1.
Ta direktiva se uporablja za zdravila za uporabo v humani medicini, ki se dajejo na trg v Skupnosti in so bodisi industrijsko izdelana ali pripravljena z uporabo metode, ki vključuje industrijski postopek.	This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2.	2.
V primeru dvoma, kadar ob upoštevanju vseh značilnosti izdelka ta lahko sodi v opredelitev „zdravila“; in v opredelitev izdelka, ki je predmet druge zakonodaje Skupnosti, se uporabijo določbe te direktive.	In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.
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3.	3.
Ne glede na odstavek 1 tega člena in člen 3(4) se naslov IV te direktive uporablja za proizvodnjo zdravil, ki so namenjena samo za izvoz, in intermediate, zdravilne učinkovine ter pomožne snovi.	Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients.
4.	4.
Odstavek 1 ne posega v člena 52b in 85a.	Paragraph 1 shall be without prejudice to Articles 52b and 85a.
▼B	▼B
Člen 3	Article 3
Ta direktiva se ne uporablja za:	This Directive shall not apply to:
1.	1.
Zdravilo, pripravljeno v lekarni po zdravniškem receptu za posameznega bolnika (splošno znano kot magistralno zdravilo).	Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).
▼M4	▼M4
2.	2.
Vsako zdravilo, pripravljeno v lekarni v skladu z recepturami v farmakopeji, namenjeno za neposredno izdajo bolnikom, ki ga dobijo v zadevni lekarni (splošno znano kot galensko zdravilo).	Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula).
3.	3.
Zdravila, namenjena za raziskave in razvojna preskušanja, vendar brez vpliva na določbe Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi ( 3 )	Medicinal products intended for research and development trials, but without prejudice to the provisions of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use ( 3 ).
▼B	▼B
4.	4.
Intermediati, namenjeni za nadaljnjo obdelavo s strani pooblaščenega proizvajalca.	Intermediate products intended for further processing by an authorized manufacturer.
5.	5.
Vse radionuklide v obliki zaprtih virov.	Any radionuclides in the form of sealed sources.
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6.	6.
Polno kri, plazmo ali krvne celice človeškega izvora, razen za plazmo, pripravljeno po metodi, ki vključuje industrijski postopek.	Whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process.
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7.	7.
Katero koli zdravilo za napredno zdravljenje, kakor je opredeljeno v Uredbi (ES) št. 1394/2007, ki je pripravljeno nerutinsko v skladu s posebnimi standardi kakovosti in uporabljeno v bolnišnici v isti državi članici ob izključni poklicni odgovornosti zdravnika v skladu s posameznim receptom za posamično zdravilo za posameznega bolnika.	Any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient.
Izdelavo teh izdelkov odobri pristojni organ države članice. Države članice zagotovijo, da so nacionalne zahteve po sledljivosti in farmakovigilanci kot tudi posebni standardi kakovosti iz tega odstavka enaki tistim, ki so za zdravila za napredno zdravljenje, za katera se zahteva odobritev v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila, zagotovljeni na ravni Skupnosti ( 4 ).	Manufacturing of these products shall be authorised by the competent authority of the Member State. Member States shall ensure that national traceability and pharmacovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalent to those provided for at Community level in respect of advanced therapy medicinal products for which authorisation is required pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( 4 ).
▼B	▼B
Člen 4	Article 4
1.	1.
Nič v tej direktivi ne sme na kakršenkoli način odstopati od pravil Skupnosti glede varstva oseb pred sevanjem zaradi zdravniških preiskav ali zdravljenja, ali od predpisov Skupnosti, ki določajo osnovne varnostne standarde za varovanje zdravja širše javnosti in delavcev pred nevarnostmi ionizirajočega sevanja.	Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment, or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation.
2.	2.
Ta direktiva ne vpliva na Odločbo Sveta 86/346/EGS z dne 25. junija 1986, ki je v imenu Skupnosti sprejel Evropski Sporazum o izmenjavi terapevtskih snovi človeškega izvora ( 5 ).	This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin ( 5 ).
3.	3.
Določbe te direktive ne vplivajo na pooblastila organov držav članic kar zadeva določanje cen zdravil ali vključevanje zdravil v programe nacionalnega zdravstvenega zavarovanja, na podlagi zdravstvenih, ekonomskih in socialnih pogojev.	The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions.
4.	4.
Ta direktiva ne vpliva na uporabo nacionalne zakonodaje glede prepovedi ali omejevanja prodaje, izdajanja ali uporabe zdravil kot so kontracepcijska sredstva ali sredstva za prekinitev nosečnosti. Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.	This Directive shall not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients. The Member States shall communicate the national legislation concerned to the Commission.
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5.	5.
Ta direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje uporabo kakršne koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi, iz razlogov, ki jih ne obravnava zgoraj navedena zakonodaja Skupnosti. Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji. Komisija te podatke objavi v registru.	This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation. The Member States shall communicate the national legislation concerned to the Commission. The Commission shall make this information publicly available in a register.
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Člen 5	Article 5
1.	1.
Država članica lahko v skladu z veljavno zakonodajo in za zadovoljevanje posebnih potreb, izvzame iz določb te direktive tista zdravila, izdana v odgovor na prostovoljno dobroverno naročilo, ki so pripravljena v skladu s specifikacijami pooblaščenega zdravstvenega delavca in, ki jih bodo posamezni bolniki uporabljali na njegovo neposredno osebno odgovornost.	A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.
2.	2.
Države članice lahko začasno izdajo dovoljenje za distribucijo zdravila, za katero ni bilo izdano dovoljenje za promet, v odgovor na domnevno ali potrjeno širjenje povzročiteljev bolezni, toksinov, kemičnih snovi ali jedrskega sevanja, ki so lahko škodljivi.	Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.
3.	3.
Brez vpliva na odstavek 1, države članice sprejmejo določbe, s katerimi zagotovijo, da imetniki dovoljenja za promet z zdravilom, izdelovalci in zdravstveni delavci niso civilno ali upravno odgovorni za posledice uporabe zdravila, razen za odobrene indikacije tega zdravila, ali za posledice uporabe zdravila brez dovoljenja za promet, katerega uporabo priporoči ali zahteva pristojni organ v odgovor na domnevno ali potrjeno širjenje povzročiteljev bolezni, toksinov, kemičnih snovi ali jedrskega sevanja, ki so lahko škodljivi. Te določbe se uporabijo ne glede na to, ali je bilo izdano dovoljenje z promet v državi ali v Skupnosti.	Without prejudice to paragraph 1, Member States shall lay down provisions in order to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not national or Community authorisation has been granted.
4.	4.
Odstavek 3 ne vpliva na odgovornost za izdelke z napako, kot jo določa Direktiva Sveta 85/374/EGS z dne 25. julija 1985 o približevanju zakonov in drugih predpisov držav članic v zvezi z odgovornostjo za proizvode z napako ( 6 ).	Liability for defective products, as provided for by Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States, concerning liability for defective products ( 6 ), shall not be affected by paragraph 3.
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NASLOV III	TITLE III
DAJANJE ZDRAVIL V PROMET	PLACING ON THE MARKET
POGLAVJE 1	CHAPTER 1
Pridobitev dovoljenja za promet z zdravilom	Marketing authorization
Člen 6	Article 6
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1.	1.
►M6 ►C1 Zdravilo je lahko v državi članici dano na trg samo na podlagi dovoljenja za promet, ki ga pristojni organi navedene države članice izdajo v skladu s to direktivo ali ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 v povezavi z Uredbo (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo ( 7 ) in Uredbo (ES) št. 1394/2007. ◄ ◄	►M6 ►C1 No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use ( 7 ) and Regulation (EC) No 1394/2007. ◄ ◄
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Kadar se prvotno dovoljenje za promet z zdravilom izda v skladu s prvim pododstavkom, se tudi za vse dodatne jakosti, farmacevtske oblike, načini uporabe zdravila, oblike pakiranj ter za vse spremembe in podaljšanja dovoljenje izda v skladu s prvim pododstavkom ali se vključi v prvotno dovoljenje za promet z zdravilom. Vsa ta dovoljenja za promet z zdravilom se štejejo kot del istega skupnega dovoljenja za promet z zdravilom, zlasti za namene uporabe člena 10(1).	When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).
1a.	1a.
Imetnik dovoljenja za promet z zdravilom je odgovoren za trženje zdravila. Imenovanje predstavnika ne razreši imetnika dovoljenja za promet z zdravilom njegove pravne odgovornosti.	The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.
▼B	▼B
2.	2.
Dovoljenje iz odstavka 1 je treba zahtevati tudi za radionuklidne generatorje, ►M4 komplete ◄ , radionuklidne predhodnike radiofarmakov ter industrijsko izdelane radiofarmacevtske izdelke.	The authorisation referred to in paragraph 1 shall also be required for radionuclide generators, ►M4 kits ◄ , radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals.
Člen 7	Article 7
Dovoljenje za promet se ne zahteva za radiofarmacevtski izdelek, pripravljen v času uporabe, ko ga pooblaščena oseba ali ustanova uporablja v skladu z nacionalno zakonodajo za uporabo tovrstnih zdravil v zdravstveni ustanovi z dovoljenjem, in je proizveden izključno iz dovoljenih radionuklidnih generatorjev, ►M4 kompletov ◄ ali radionuklidnih predhodnikov v skladu z navodili proizvajalca.	A marketing authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized radionuclide generators, ►M4 kits ◄ or radionuclide precursors in accordance with the manufacturer's instructions.
Člen 8	Article 8
1.	1.
Za pridobitev dovoljenja za dajanje zdravila v promet ne glede na postopek, ki ga določa Uredba (EGS) št. 2309/93, se pri pristojnem organu zadevne države članice vloži vlogo.	In order to obtain an authorization to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned.
2.	2.
Dovoljenje za promet z zdravilom se lahko izda samo vlagatelju, ki ima sedež oziroma stalno bivališče v Skupnosti.	A marketing authorization may only be granted to an applicant established in the Community.
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2a.	2a.
Z odstopanjem od odstavka 2 lahko pristojni organi Združenega kraljestva v zvezi s Severno Irsko izdajo dovoljenja za promet vlagateljem, ki imajo sedež v delih Združenega kraljestva razen Severne Irske.	By way of derogation from paragraph 2, marketing authorisations may be granted by the competent authorities of the United Kingdom in respect of Northern Ireland to applicants established in parts of the United Kingdom other than Northern Ireland.
2b.	2b.
Z odstopanjem od odstavka 2 lahko pristojni organi Združenega kraljestva v zvezi s Severno Irsko in do 31. decembra 2024 pristojni organi Cipra, Irske in Malte izdajo dovoljenja za promet v skladu s postopkom z medsebojnim priznavanjem ali decentraliziranim postopkom iz poglavja 4 tega naslova imetnikom dovoljenj za promet s sedežem v delih Združenega kraljestva razen Severne Irske.	By way of derogation from paragraph 2, marketing authorisations may be granted by the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, by the competent authorities of Cyprus, Ireland and Malta, in accordance with the mutual recognition or the decentralised procedure laid down in Chapter 4 of this Title, to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.
Pristojni organi Združenega kraljestva v zvezi s Severno Irsko in do 31. decembra 2024 pristojni organi Cipra, Irske in Malte lahko podaljšajo dovoljenja za promet, ki so že bila izdana pred 20. aprilom 2022 imetnikom dovoljenja za promet s sedežem v delih Združenega kraljestva razen Severne Irske.	The competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta may extend marketing authorisations already granted prior to 20 April 2022 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.
Dovoljenja za promet, ki jih izdajo ali podaljšajo pristojni organi Cipra, Irske ali Malte v skladu s prvim in drugim pododstavkom, prenehajo veljati najpozneje 31. decembra 2026.	The marketing authorisations granted or extended by the competent authorities of Cyprus, Ireland or Malta in accordance with the first and second subparagraph shall cease to be valid at the latest on 31 December 2026.
▼B	▼B
3.	3.
Vlogi se priložijo naslednji podatki in dokumenti v skladu s Prilogo I:	The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:
(a)	(a)
Ime ali naziv podjetja in stalni naslov vlagatelja ter, kadar je to primerno, proizvajalca.	Name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer.
▼M4	▼M4
(b)	(b)
Ime zdravila.	Name of the medicinal product.
(c)	(c)
Podatki o kakovostni in količinski sestavi zdravila, vključno z navedbo mednarodnega nelastniškega imena (INN), ki ga priporoča Svetovna zdravstvena organizacija, kadar INN obstaja, ali navedba ustreznega kemijskega imena.	Qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or a reference to the relevant chemical name.
▼M4	▼M4
(ca)	(ca)
Ocena možnih tveganj za okolje, ki jih predstavlja zdravilo. Ta vpliv na okolje se oceni in od primera do primera predvidijo posebne ureditve za omejevanje tega vpliva.	Evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged.
▼B	▼B
(d)	(d)
Opis postopka izdelave.	Description of the manufacturing method.
(e)	(e)
Terapevtske indikacije, kontraindikacije in neželeni učinki.	Therapeutic indications, contra-indications and adverse reactions.
(f)	(f)
Odmerjanje, farmacevtska oblika, način in pot uporabe zdravila in pričakovani rok uporabnosti.	Posology, pharmaceutical form, method and route of administration and expected shelf life.
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(g)	(g)
Navedejo se razlogi za previdnostne in varnostne ukrepe pri shranjevanju zdravila, pri dajanju zdravila bolnikom in pri odlaganju odpadkov, skupaj z navedbo vseh možnih tveganj, ki jih zdravilo predstavlja za okolje.	Reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment.
(h)	(h)
Opis kontrolnih metod, ki jih izdelovalec uporablja.	Description of the control methods employed by the manufacturer.
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(ha)	(ha)
Pisno potrdilo, da je proizvajalec zdravila preveril skladnost proizvajalca zdravilne učinkovine z načeli in smernicami dobre proizvodne prakse z izvedbo presoj v skladu s točko (f) člena 46. Pisno potrdilo vsebuje sklicevanje na datum presoje in izjavo, da je izid presoje potrdil, da proizvodnja poteka v skladu z načeli in smernicami dobre proizvodne prakse.	A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.
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(i)	(i)
Rezultati:	Results of:
—	—
farmacevtskih (fizikalno-kemijskih, bioloških in mikrobioloških) preskusov,	pharmaceutical (physico-chemical, biological or microbiological) tests,
—	—
predkliničnih (toksikoloških in farmakoloških) preskusov,	pre-clinical (toxicological and pharmacological) tests,
—	—
kliničnih preskušanj.	clinical trials.
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(ia)	(ia)
Povzetek sistema farmakovigilance vlagatelja, ki vsebuje naslednje elemente:	A summary of the applicant’s pharmacovigilance system which shall include the following elements:
—	—
dokazilo, da ima vlagatelj na voljo storitve usposobljene osebe, odgovorne za farmakovigilanco,	proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance,
—	—
države članice, kjer ima usposobljena oseba prebivališče in opravlja svoje delo,	the Member States in which the qualified person resides and carries out his/her tasks,
—	—
kontaktni podatki usposobljene osebe,	the contact details of the qualified person,
—	—
izjava, ki jo podpiše vlagatelj, da ima vlagatelj potrebna sredstva za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX,	a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX,
—	—
napotilo na mesto, kjer se hrani glavni dosje o sistemu farmakovigilance za zdravilo.	a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.
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(iaa)	(iaa)
Načrt za obvladovanje tveganj z opisom sistema obvladovanja tveganja, ki ga bo vlagatelj uvedel za zadevno zdravilo, skupaj s povzetkom načrta.	The risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof.
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(ib)	(ib)
Izjava, iz katere je razvidno, da klinična preskušanja, opravljena zunaj Evropske unije, izpolnjujejo etične zahteve Direktive 2001/20/ES.	A statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC.
(j)	(j)
V skladu s členom 11 povzetek glavnih značilnosti zdravila, osnutek zunanje ovojnine z navedbami podatkov iz člena 54 in stične ovojnine zdravila z navedbami iz člena 55, skupaj z navodilom za uporabo v skladu s členom 59.	A summary, in accordance with Article 11, of the product characteristics, a mock-up of the outer packaging, containing the details provided for in Article 54, and of the immediate packaging of the medicinal product, containing the details provided for in Article 55, together with a package leaflet in accordance with Article 59.
▼B	▼B
(k)	(k)
Dokument, ki dokazuje, da ima proizvajalec v svoji državi dovoljenje za proizvodnjo zdravil.	A document showing that the manufacturer is authorised in his own country to produce medicinal products.
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(l)	(l)
Izvodi:	Copies of the following:
—	—
vseh dovoljenj za dajanje zdravil na trg, pridobljenih v drugi državi članici ali v tretji državi, povzetka varnostnih podatkov vključno tistih iz rednih posodobljenih poročil o varnosti, če so na voljo, in poročil o domnevnih neželenih učinkih, skupaj s seznamom tistih držav članic, v katerih je bila vloga za pridobitev dovoljenja predložena v skladu s to direktivo in je v postopku obravnave,	any authorisation, obtained in another Member State or in a third country, to place the medicinal product on the market, a summary of the safety data including the data contained in the periodic safety update reports, where available, and suspected adverse reactions reports, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination;
—	—
povzetka glavnih značilnosti zdravila, ki ga vlagatelj predlaga v skladu s členom 11 ali ki so ga odobrili pristojni organi države članice v skladu s členom 21 in navodila za uporabo, predlaganega v skladu s členom 59 ali odobrenega s strani pristojnih organov države članice v skladu s členom 61,	the summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21 and the package leaflet proposed in accordance with Article 59 or approved by the competent authorities of the Member State in accordance with Article 61;
—	—
podrobnosti vsake odločitve o zavrnitvi izdaje dovoljenja za promet z zdravilom bodisi v Uniji ali v tretji državi, ter razloge za tako odločitev.	details of any decision to refuse authorisation, whether in the Union or in a third country, and the reasons for such a decision.
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(m)	(m)
Izvod vsakršnega dokumenta, ki zdravilo označuje kot zdravilo siroto po Uredbi (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah ( 8 ), skupaj s kopijo ustreznega mnenja Agencije.	A copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products ( 8 ), accompanied by a copy of the relevant Agency opinion.
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Dokumente in informacije o rezultatih farmacevtskih in predkliničnih preskusov in kliničnih preskušanj iz točke (i) prvega pododstavka morajo v skladu s členom 12 spremljati podrobni povzetki.	The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in point (i) of the first subparagraph shall be accompanied by detailed summaries in accordance with Article 12.
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Načrt obvladovanja tveganj z opisom sistema obvladovanja tveganja iz točke (iaa) prvega pododstavka je sorazmeren z ugotovljenimi tveganji in možnimi tveganji zdravila ter potrebo po podatkih o varnosti zdravila po pridobitvi dovoljenja za promet.	The risk management system referred to in point (iaa) of the first subparagraph shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.
Podatki iz prvega pododstavka se posodobijo, če in ko je to potrebno.	The information referred to in the first subparagraph shall be updated where and when appropriate.
▼B	▼B
Člen 9	Article 9
Poleg zahtev iz členov 8 in 10(1), vloga za pridobitev dovoljenja za promet radionuklidnega generatorja vsebuje tudi naslednje informacije in podrobnosti:	In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars:
—	—
splošen opis sistema in podroben opis komponent sistema, ki lahko vplivajo na sestavo ali kakovost hčerinskega nuklidnega pripravka,	a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation,
—	—
podrobnosti o kakovostni in količinski sestavi eluata ali sublimata.	qualitative and quantitative particulars of the eluate or the sublimate.
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Člen 10	Article 10
1.	1.
Z odstopanjem od člena 8(3)(i) in brez vpliva na zakon o varstvu industrijske in poslovne lastnine, se od predlagatelja ne zahteva predložitev rezultatov predkliničnih preskusov in kliničnih preskušanj, če lahko dokaže, da je zdravilo generična oblika zdravila, ki ima v državi članici ali v Skupnosti na podlagi člena 6 dovoljenje za promet z zdravilom najmanj osem let.	By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community.
Generično zdravilo, ki je pridobilo dovoljenje za promet skladno s to določbo, ne sme biti v prometu dokler ne preteče 10 let od izdaje prvotnega dovoljenja za promet za referenčno zdravilo.	A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product.
Prvi pododstavek se uporabi tudi, če referenčno zdravilo ni pridobilo dovoljenja za promet v državi članici, v kateri je bila vložena vloga za pridobitev dovoljenje za promet z generičnim zdravilom. V tem primeru predlagatelj v obrazcu za pridobitev dovoljenja navede ime države članice, v kateri je ali je bilo pridobljeno dovoljenje z promet z referenčnim zdravilom. Na zahtevo pristojnega organa države članice, v kateri se vloži vloga za pridobitev dovoljenja za promet, pristojni organ druge države članice v obdobju enega meseca izda potrdilo, da je ali je bilo pridobljeno dovoljenje za promet z referenčnim zdravilom, ter popolno sestavo referenčnega zdravila in vso drugo pomembno dokumentacijo, če je to potrebno.	The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation.
Obdobje desetih let iz drugega pododstavka se podaljša na največ 11 let, če v prvih osmih letih obdobja desetih let imetnik dovoljenja za promet z zdravilom pridobi dovoljenje za eno ali več novih terapevtskih indikacij, za katere se med znanstvenim ocenjevanjem pred izdajo dovoljenja ugotovi, da v primerjavi z obstoječimi terapijami prinašajo pomembne klinične koristi.	The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.
2.	2.
V tem členu:	For the purposes of this Article:
(a)	(a)
„referenčno zdravilo“; pomeni zdravilo, ki je pridobilo dovoljenje za promet na podlagi člena 6, v skladu z določbami člena 8;	‘reference medicinal product’ shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8;
(b)	(b)
„generično zdravilo“; pomeni zdravilo, ki ima enako kakovostno in količinski sestavi zdravilnih učinkovin in enako farmacevtsko obliko kot referenčno zdravilo, in katerega bioekvivalenca z referenčnim zdravilom je bila dokazana z ustreznimi študijami biološke uporabnosti. Različne soli, estri, etri, izomeri, mešanice izomerov, kompleksi ali derivati zdravilne učinkovine se štejejo kot ena zdravilna učinkovina, razen če se pomembno razlikujejo glede varnosti in/ali učinkovitosti. V takih primerih mora predlagatelj predložiti dodatne podatke, ki dokazujejo varnost in/ali učinkovitost različnih soli, estrov ali derivatov odobrene zdravilne učinkovine. Različne peroralne farmacevtske oblike s takojšnjim sproščanjem se štejejo za eno farmacevtsko obliko. Študij biološke uporabnosti ni treba zahtevati od predlagatelja, če lahko dokaže, da generično zdravilo izpolnjuje ustrezna merila, določena v ustreznih podrobnih smernicah.	‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.
3.	3.
Kadar zdravilo ne sodi v opredelitev generičnega zdravila iz odstavka 2(b) ali če bioekvivalence ni mogoče dokazati s študijami biološke uporabnosti ali v primeru sprememb zdravilnih učinkovin, terapevtskih indikacij, jakosti, farmacevtske oblike ali poti uporabe zdravila glede na referenčno zdravilo je treba predložiti rezultate ustreznih predkliničnih preskusov ali kliničnih preskušanj.	In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.
4.	4.
Kadar biološko zdravilo, ki je podobno referenčnemu biološkemu zdravilu ne izpolnjuje pogojev v opredelitvi generičnih zdravil, predvsem zaradi razlik v surovinah ali razlik v procesu izdelave biološkega zdravila in referenčnega biološkega zdravila, je treba predložiti rezultate ustreznih predkliničnih preskusov ali kliničnih preskušanj v zvezi s temi pogoji. Vrsta in količina dodatnih podatkov, ki jih je treba predložiti, mora biti v skladu z ustreznimi merili iz Priloge I ter podrobnih smernic. Rezultati drugih preskusov in preskušanj iz dosjeja referenčnega zdravila se ne predložijo.	Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided.
5.	5.
Če se vloži vloga za novo indikacijo dobro uveljavljene učinkovine poleg določb iz odstavka 1 velja za ekskluzivnost podatkov nekumulativno obdobje enega leta, pod pogojem, da so bile opravljene pomembne predklinične ali klinične študije v zvezi z novo indikacijo.	In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.
6.	6.
Izvajanje potrebnih študij in preskusov zaradi uporabe odstavkov 1, 2, 3 in 4 in posledične praktične zahteve se ne obravnavajo kot nasprotne patentnim pravicam ali certifikatom o dodatni zaščiti zdravil.	Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.
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Člen 10a	Article 10a
Z odstopanjem od člena 8(3)(i) in brez vpliva na zakon o varovanju industrijske in poslovne lastnine, se od predlagatelja ne zahteva predložitev rezultatov predkliničnih preskusov ali kliničnih preskušanj, če lahko dokaže, da imajo zdravilne učinkovine zdravila že dobro uveljavljeno medicinsko uporabo v Skupnosti vsaj deset let, z znano učinkovitostjo in sprejemljivo stopnjo varnosti glede na pogoje iz Priloge I. V tem primeru se rezultate preskusov in preskušanj nadomesti z ustrezno strokovno literaturo.	By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature.
Člen 10b	Article 10b
Za zdravila, ki vsebujejo zdravilne učinkovine, ki so uporabljene v sestavi zdravil, ki so pridobila dovoljenje za promet, vendar tu niso uporabljene v kombinaciji za terapevtske namene, se rezultati novih predkliničnih preskusov ali novih kliničnih preskušanj v zvezi s to kombinacijo zagotovijo v skladu s členom 8(3)(i), vendar ni nujno zagotoviti znanstvenih referenc za vsako posamezno zdravilno učinkovino.	In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance.
Člen 10c	Article 10c
Po izdaji dovoljenja za promet z zdravilom lahko imetnik dovoljenja za promet dovoli uporabo farmacevtske, predklinične in klinične dokumentacije iz dosjeja o zdravilu zaradi preučevanja kasnejših vlog za druga zdravila, ki imajo enako kakovostno in količinsko sestavo zdravilnih učinkovin ter enako farmacevtsko obliko.	Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.
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Člen 11	Article 11
Povzetek glavnih značilnosti zdravila vsebuje naslednje podatke v spodaj navedenem zaporedju:	The summary of the product characteristics shall contain, in the order indicated below, the following information:
1.	1.
Ime zdravila, ki mu sledi jakost in farmacevtska oblika.	name of the medicinal product followed by the strength and the pharmaceutical form.
2.	2.
Kakovostna in količinska sestava zdravilnih učinkovin in pomožnih snovi, kar je bistvenega pomena za ustrezno dajanje zdravila. Uporablja se običajno splošno ime ali kemijsko ime.	qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used.
3.	3.
Farmacevtska oblika.	pharmaceutical form.
4.	4.
Klinični podatki:	clinical particulars:
4.1	4.1.
terapevtske indikacije;	therapeutic indications,
4.2	4.2.
odmerjanje in način uporabe za odrasle in, kadar je to potrebno, za otroke;	posology and method of administration for adults and, where necessary for children,
4.3	4.3.
kontraindikacije;	contra-indications,
4.4	4.4.
posebna opozorila in previdnostni ukrepi pri uporabi in če gre za imunološka zdravila, vse posebne previdnostne ukrepe, ki jih morajo osebe, ki imajo opraviti s takimi zdravili in jih dajejo bolnikom, upoštevati skupaj z vsemi previdnostnimi ukrepi, ki jih mora upoštevati bolnik;	special warnings and precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient,
4.5	4.5.
medsebojno delovanje z drugimi zdravili in druge oblike interakcij;	interaction with other medicinal products and other forms of interactions,
4.6	4.6.
uporaba med nosečnostjo in dojenjem;	use during pregnancy and lactation,
4.7	4.7.
vpliv na sposobnost vožnje in upravljanje s stroji;	effects on ability to drive and to use machines,
4.8	4.8.
neželeni učinki;	undesirable effects,
4.9	4.9.
preveliko odmerjanje (simptomi, nujni ukrepi, antidoti).	overdose (symptoms, emergency procedures, antidotes).
5.	5.
Farmakološki podatki:	pharmacological properties:
5.1	5.1.
farmakodinamične lastnosti,	pharmacodynamic properties,
5.2	5.2.
farmakokinetične lastnosti,	pharmacokinetic properties,
5.3	5.3.
predklinični podatki o varnosti.	preclinical safety data.
6.	6.
Farmacevtski podatki:	pharmaceutical particulars:
6.1	6.1.
seznam pomožnih snovi,	list of excipients,
6.2	6.2.
glavne inkompatibilnosti,	major incompatibilities,
6.3	6.3.
rok uporabnosti, če je potrebno po rekonstituciji zdravila ali po prvem odpiranju stične ovojnine,	shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,
6.4	6.4.
posebna navodila za shranjevanje,	special precautions for storage,
6.5	6.5.
narava in vsebina ovojnine,	nature and contents of container,
6.6	6.6.
posebni previdnostni ukrepi pri odlaganju uporabljenih zdravil ali odpadkov, ki iz njih nastanejo, če je to primerno.	special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product, if appropriate.
7.	7.
Imetnik dovoljenja za promet z zdravilom.	marketing authorisation holder.
8.	8.
Številka(e) dovoljenja za promet z zdravili.	marketing authorisation number(s).
9.	9.
Datum prve pridobitve ali podaljšanja dovoljenja za promet.	date of the first authorisation or renewal of the authorisation.
10.	10.
Datum revizije besedila.	date of revision of the text.
11.	11.
Za radiofarmacevstke izdelke, podrobne podatke o interni radiacijski dozimetriji.	for radiopharmaceuticals, full details of internal radiation dosimetry.
12.	12.
Za radiofarmacevtske izdelke dodatna podrobna navodila za sprotno pripravo in nadzor kakovosti takega pripravka, in kadar je to primerno, še najdaljši čas shranjevanja, v katerem vmesni izdelek kot je eluat ali na mestu pripravljeno zdravilo, ustreza specifikacijam.	for radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.
Za dovoljenja za promet iz člena 10, ni treba vključiti tistih delov povzetka glavnih značilnosti referenčnega zdravila, ki se nanašajo na indikacije ali farmacevtske oblike, za katere je v času, ko je bilo generično zdravilo v prometu, še vedno veljalo patentno pravo.	For authorisations under Article 10, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included.
▼M10	▼M10
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 povzetek glavnih značilnosti zdravila vključuje izjavo: „Za to zdravilo se izvaja dodatno spremljanje varnosti.“. Pred to izjavo je črn simbol iz člena 23 Uredbe (ES) št. 726/2004, sledi pa ji standardna kratka obrazložitev.	For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary of product characteristics shall include the statement: ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726/2004 and followed by an appropriate standardised explanatory sentence.
Za vsa zdravila se vključi standardno besedilo, ki od zdravstvenih delavcev izrecno zahteva, naj poročajo o vseh domnevnih neželenih učinkih v skladu z nacionalnim sistemom spontanega poročanja iz člena 107a(1). V skladu z drugim pododstavkom člena 107a(1) so na voljo različni načini poročanja, vključno z elektronskim poročanjem.	For all medicinal products, a standard text shall be included expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting system referred to in Article 107a(1). Different ways of reporting, including electronic reporting, shall be available in compliance with the second subparagraph of Article 107a(1).
▼M4	▼M4
Člen 12	Article 12
1.	1.
Predlagatelj zagotovi, da podrobne povzetke iz zadnjega pododstavka člena 8(3), preden se ti predložijo pristojnim organom, pripravijo in podpišejo strokovnjaki, ki imajo potrebne tehnične ali strokovne kvalifikacije, kar navedejo v kratkem življenjepisu.	The applicant shall ensure that, before the detailed summaries referred to in the last subparagraph of Article 8(3) are submitted to the competent authorities, they have been drawn up and signed by experts with the necessary technical or professional qualifications, which shall be set out in a brief curriculum vitae.
2.	2.
Osebe, ki imajo tehnične in strokovne kvalifikacije, navedene v odstavku 1, utemeljijo vsako uporabo strokovne literature po členu 10a v skladu s pogoji iz Priloge I.	Persons having the technical and professional qualifications referred to in paragraph 1 shall justify any use made of scientific literature under Article 10a in accordance with the conditions set out in Annex I.
3.	3.
Podrobni povzetki so del dokumentacije, ki jo predlagatelj predloži pristojnim organom.	The detailed summaries shall form part of the file which the applicant submits to the competent authorities.
▼B	▼B
POGLAVJE 2	CHAPTER 2
Posebne določbe, ki se uporabljajo za homeopatska zdravila	Specific provisions applicable to homeopathic medicinal products
▼M4	▼M4
Člen 13	Article 13
1.	1.
Države članice zagotovijo, da se homeopatska zdravila, ki se izdelujejo in dajejo v promet v Skupnosti, registrirajo ali pridobijo dovoljenje za promet v skladu s členi 14, 15 in 16, razen kadar so ta zdravila zajeta z registracijo ali pridobitvijo dovoljenja za promet po nacionalni zakonodaji na dan ali pred 31. decembrom 1993. V primeru registracije se uporabita člen 28 in člen 29(1) do (3).	Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.
2.	2.
Države članice vzpostavijo poseben poenostavljen postopek registracije homeopatskih zdravil iz člena 14.	Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14.
▼B	▼B
Člen 14	Article 14
1.	1.
Po posebnem, poenostavljenem postopku je možno registrirati samo homeopatska zdravila, ki izpolnjujejo vse naslednje pogoje:	Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:
—	—
da se dajejo peroralno ali zunanje,	they are administered orally or externally,
—	—
da na ovojnini izdelka niso navedene nobene posebne terapevtske indikacije ali druge informacije s tem v zvezi,	no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto,
—	—
da je izdelek dovolj razredčen, in je zajamčena njegova varnost; izdelek zlasti ne sme vsebovati več kot en del pratinkture na 10 000 delov, ali več kot 1/100 najmanjšega odmerka zdravilne učinkovine, ki se uporablja v alopatiji in katerih prisotnost v alopatskem zdravilu zahteva obvezno izdajo na zdravniški recept.	there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription.
▼M15	▼M15
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za spremembo tretje alineje prvega pododstavka, če to upravičujejo novi znanstveni dokazi.	The Commission is empowered to adopt delegated acts in accordance with Article 121a amending the third indent of the first subparagraph if new scientific evidence so warrants.
▼B	▼B
Ob času registracije, države članice določijo razvrstitev glede izdajanja homeopatskega zdravila.	At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.
2.	2.
Merila in pravila postopka, predpisana v členu 4(4), členu 17(1) in členih 22 do 26, 112, 116 in 125, se smiselno uporabljajo pri posebnem, poenostavljenem postopku registracije homeopatskih zdravil, razen dokaza o terapevtski učinkovitosti.	The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.
▼M4 —————	▼M4 —————
▼B	▼B
Člen 15	Article 15
Vloga za posebno poenostavljeno registracijo lahko zajema serijo zdravil, pridobljenih iz iste homeopatske surovine ali surovin. V vlogo se vključijo naslednji dokumenti, da se dokaže zlasti farmacevtska kakovost in homogenost serij zadevnih izdelkov:	An application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:
—	—
znanstveno ime ali drugo ime iz farmakopeje za homeopatsko surovino ali surovine, skupaj z navedbo različnih poti uporabe izdelka, farmacevtskih oblik ter stopnje razredčitve, ki se jo želi registrirati,	scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,
▼M4	▼M4
—	—
dosje z opisom, kako se pridobiva in nadzira homeopatska surovina ali surovine, in utemeljitvijo homeopatske uporabe surovine ali surovin, na podlagi ustrezne bibliografije,	dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic use, on the basis of an adequate bibliography,
▼B	▼B
—	—
dokumentacija o proizvodnji in nadzoru za vsako farmacevtsko obliko ter opis metode razredčevanja in potenciranja,	manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,
—	—
dovoljenje za proizvodnjo zadevnega zdravila,	manufacturing authorization for the medicinal product concerned,
—	—
kopije vseh registracij ali dovoljenj za promet, pridobljenih v drugih državah članicah za isto zdravilo,	copies of any registrations or authorizations obtained for the same medicinal product in other Member States,
▼M4	▼M4
—	—
en ali več vzorcev zunanje in stične ovojnine zdravila v naravni velikosti v postopku registracije,	one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered,
▼B	▼B
—	—
podatke o stabilnosti homeopatskega zdravila.	data concerning the stability of the medicinal product.
Člen 16	Article 16
1.	1.
Za homeopatska zdravila, ki niso navedena v členu 14(1), je treba pridobiti dovoljenje za promet in jih označiti v skladu s ►M4 členi 8, 10, 10a, 10b, 10c in 11 ◄ .	Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorized and labelled in accordance with ►M4 Articles 8, 10, 10a, 10b, 10c and 11 ◄ .
2.	2.
Država članica na svojem ozemlju lahko uvede ali ohrani posebna pravila za ►M4 predklinične preskuse ◄ ter klinična preskušanja homeopatskih zdravil, ki se razlikujejo od navedenih v členu 14(1) v skladu z načeli in značilnostmi homeopatske dejavnosti, kakor se opravlja v tej državi članici.	A Member State may introduce or retain in its territory specific rules for the ►M4 preclinical tests ◄ and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State.
Država članica o posebnih pravilih, ki veljajo na njenem ozemlju, obvesti Komisijo.	In this case, the Member State concerned shall notify the Commission of the specific rules in force.
3.	3.
Naslov IX se uporablja za homeopatska zdravila razen navedenih v členu 14(1).	Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1).
▼M3	▼M3
POGLAVJE 2a	CHAPTER 2a
Posebne določbe, ki se uporabljajo za tradicionalna zdravila rastlinskega izvora	Specific provisions applicable to traditional herbal medicinal products
Člen 16a	Article 16a
1.	1.
Za zdravila rastlinskega izvora, ki izpolnjujejo vsa naslednja merila, se s tem določi poenostavljen postopek registracije (v nadaljevanju „registracija zaradi tradicionalne uporabe“):	A simplified registration procedure (hereinafter ‘traditional-use registration’) is hereby established for herbal medicinal products which fulfil all of the following criteria:
(a)	(a)
imajo terapevtske indikacije, ki so izključno primerne za tradicionalna zdravila rastlinskega izvora, ki so zaradi svoje sestave in namena namenjena in zasnovana za uporabo brez zdravniškega nadzora za diagnostične namene ali za predpisovanje ali spremljanje zdravljenja;	they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
(b)	(b)
so izključno za dajanje v skladu z določeno jakostjo in odmerjanjem;	they are exclusively for administration in accordance with a specified strength and posology;
(c)	(c)
so pripravki za peroralno uporabo, zunanjo uporabo in/ali za vdihavanje;	they are an oral, external and/or inhalation preparation;
(d)	(d)
obdobje tradicionalne uporabe, kakor je določeno v členu 16c(1)(c), je poteklo;	the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(e)	(e)
podatki o tradicionalni uporabi zdravila so zadostni; zlasti izdelek dokazano ni škodljiv v določenih pogojih uporabe in farmakološki učinki ali učinkovitost zdravila so verjetni na podlagi dolgotrajne uporabe in izkušenj.	the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.
2.	2.
Ne glede na člen 1(30) prisotnost vitaminov ali mineralov v zdravilih rastlinskega izvora za varnost, za katero obstajajo dobro dokumentirani dokazi, ne preprečuje izdelku upravičenosti do registracije v skladu z odstavkom 1, pod pogojem, da vitamini ali minerali podpirajo delovanje rastlinskih učinkovin glede določene(ih) navedene(ih) terapevtske(ih) indikacij(e).	Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).
3.	3.
V primerih, ko pa pristojni organi presodijo, da tradicionalno zdravilo rastlinskega izvora izpolnjuje merila za pridobitev dovoljenja za promet v skladu s členom 6 ali registracijo na podlagi člena 14, se določbe tega poglavja ne uporabljajo.	However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall not apply.
Člen 16b	Article 16b
1.	1.
Predlagatelj in imetnik registracije imata sedež v Skupnosti.	The applicant and registration holder shall be established in the Community.
2.	2.
Za pridobitev registracije zaradi tradicionalne uporabe predlagatelj vlogo predloži pristojnemu organu zadevne države članice.	In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned.
Člen 16c	Article 16c
1.	1.
Vlogi mora biti priloženo:	The application shall be accompanied by:
(a)	(a)
podatki in listine:	the particulars and documents:
(i)	(i)
iz člena 8(3)(a) do (h), (j) in (k);	referred to in Article 8(3)(a) to (h), (j) and (k);
(ii)	(ii)
rezultati farmacevtskih preskusov iz druge alinee člena 8(3)(i);	the results of the pharmaceutical tests referred to in the second indent of Article 8(3)(i);
(iii)	(iii)
povzetek glavnih značilnosti zdravila, brez podatkov, določenih v členu 11(4);	the summary of product characteristics, without the data specified in Article 11(4);
(iv)	(iv)
v primeru kombinacij, kakor je navedeno v členu 1(30) ali členu 16a(2), informacije iz člena 16a(1)(e), ki se nanašajo na kombinacijo kot tako; če posamezne učinkovine niso zadosti poznane, se podatki nanašajo tudi na posamezne učinkovine;	in case of combinations, as referred to in Article 1(30) or Article 16a(2), the information referred to in Article 16a(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall also relate to the individual active ingredients;
(b)	(b)
dovoljenja za promet ali registracije, ki jih je predlagatelj pridobil v drugi državi članici ali v tretji državi za dajanje zdravila v promet, in podrobnosti kakršne koli odločitve o zavrnitvi podelitve dovoljenja ali registracije v Skupnosti ali v tretji državi in razlogi za kakršno koli tako odločitev;	any authorisation or registration obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant an authorisation or registration, whether in the Community or a third country, and the reasons for any such decision;
(c)	(c)
bibliografski ali strokovni dokazi, da je bilo zadevno ali ustrezajoče zdravilo v medicinski uporabi najmanj 30 let pred datumom vloge, vključno najmanj 15 let v Skupnosti. Na zahtevo države članice, kjer je bila predložena vloga za registracijo zaradi tradicionalne uporabe, Odbor za zdravila rastlinskega izvora pripravi mnenje o ustreznosti dokazov o dolgotrajni uporabi tega ali ustrezajočega zdravila. Država članica posredovanju predloži ustrezno dokumentacijo;	bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community. At the request of the Member State where the application for traditional-use registration has been submitted, the Committee for Herbal Medicinal Products shall draw up an opinion on the adequacy of the evidence of the long-standing use of the product, or of the corresponding product. The Member State shall submit relevant documentation supporting the referral;
(d)	(d)
bibliografski pregled podatkov o varnosti skupaj z izvedenskim poročilom, in kadar pristojni organ dodatno zahteva, podatki, ki so potrebni za oceno varnosti zdravila.	a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional request, data necessary for assessing the safety of the medicinal product.
Priloga I se uporablja po analogiji za podatke in listine, določene v točki (a).	Annex I shall apply by analogy to the particulars and documents specified in point (a).
2.	2.
Za ustrezajoče zdravilo iz odstavka 1(c) je značilno, da ima enake učinkovine ne glede na uporabljene pomožne snovi, enak ali podoben namen uporabe, enakovredno jakost in odmerjanje ter enak ali podoben način uporabe kot zdravilo, za katerega se predlaga vloga.	A corresponding product, as referred to in paragraph 1(c), is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for.
3.	3.
Zahteva, da se navede medicinska uporaba v obdobju 30 let iz odstavka 1(c), je izpolnjena tudi, kadar dajanje v promet izdelka ne temelji na posebnem dovoljenju. Izpolnjena je tudi, če je bilo število ali količina sestavin zdravila v navedenem obdobju zmanjšano.	The requirement to show medicinal use throughout the period of 30 years, referred to in paragraph 1(c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period.
4.	4.
Kadar se zdravilo v Skupnosti uporablja manj kot 15 let, vendar sicer izpolnjuje pogoje za poenostavljeno registracijo, država članica, v kateri je bila predložena vloga za registracijo zaradi tradicionalne uporabe, predloži zdravilo Odboru za zdravila rastlinskega izvora. Država članica posredovanju predloži ustrezno dokumentacijo.	Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral.
Odbor preuči, ali so druga merila za poenostavljeno registracijo, kakor je navedeno v členu 16, v celoti izpolnjena. Če Odbor meni, da je mogoče, pripravi rastlinsko monografijo Skupnosti, kakor je navedena v členu 16h(3), ki jo država članica upošteva pri dokončni odločitvi.	The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision.
Člen 16d	Article 16d
1.	1.
Brez poseganja v člen 16h(1) se Poglavje 4 Naslova III po analogiji uporablja za registracije, dodeljene v skladu s členom 16a, pod pogojem, da:	Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
(a)	(a)
je pripravljena rastlinska monografija Skupnosti v skladu s členom 16h(3); ali	a Community herbal monograph has been established in accordance with Article 16h(3), or
(b)	(b)
je zdravilo rastlinskega izvora sestavljeno iz rastlinskih snovi, pripravkov ali kombinacij iz njih, s seznama iz člena 16f.	the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
2.	2.
Za druga zdravila rastlinskega izvora, kakor so navedena v členu 16a, vsaka država članica pri ovrednotenju vloge za registracijo zaradi tradicionalne uporabe upošteva registracije, ki jih je dodelila druga država članica v skladu s tem poglavjem.	For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter.
Člen 16e	Article 16e
1.	1.
Registracija zaradi tradicionalne uporabe se zavrne, če vloga ni skladna s členi 16a, 16b ali 16c, ali če je izpolnjen najmanj eden od naslednjih pogojev:	Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b or 16c or if at least one of the following conditions is fulfilled:
(a)	(a)
kakovostna in/ali količinska sestava ne ustreza deklarirani;	the qualitative and/or quantitative composition is not as declared;
(b)	(b)
terapevtske indikacije niso v skladu s pogoji, določenimi v členu 16a;	the indications do not comply with the conditions laid down in Article 16a;
(c)	(c)
zdravilo bi bilo lahko škodljivo v običajnih pogojih uporabe;	the product could be harmful under normal conditions of use;
(d)	(d)
podatki o tradicionalni uporabi niso zadostni, zlasti če farmakološki učinki ali učinkovitost niso verjetni na podlagi dolgotrajne uporabe in izkušenj;	the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience;
(e)	(e)
farmacevtska kakovost ni zadovoljivo dokazana.	the pharmaceutical quality is not satisfactorily demonstrated.
2.	2.
Pristojni organi držav članic obvestijo predlagatelja, Komisijo in pristojni organ, ki to zahteva, o vseh sklepih o zavrnitvi registracije zaradi tradicionalne uporabe in o razlogih za zavrnitev.	The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for the refusal.
Člen 16f	Article 16f
1.	1.
V skladu s postopkom iz člena 121(2) se vzpostavi seznam rastlinskih snovi, pripravkov ter kombinacij iz njih. Seznam za vsako rastlinsko snov vsebuje terapevtsko indikacijo, določeno jakost in odmerjanje, način uporabe in kakršne koli druge informacije, ki so potrebne za varno uporabo rastlinske snovi kot tradicionalnega zdravila rastlinskega izvora.	A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product.
2.	2.
Če se vloga za registracijo zaradi tradicionalne uporabe nanaša na rastlinsko snov, pripravek ali kombinacijo iz njih, ki je na seznamu iz odstavka 1, ni treba zagotoviti podatkov, določenih v členu 16c(1)(b)(c) in (d). Člen 16e(1)(c) in (d) se ne uporablja.	If an application for traditional-use registration relates to a herbal substance, preparation or a combination thereof contained in the list referred to in paragraph 1, the data specified in Article 16c(1)(b)(c) and (d) do not need to be provided. Article 16e(1)(c) and (d) shall not apply.
3.	3.
Če rastlinska snov, pripravek ali kombinacija iz njih preneha biti vključena v seznam iz odstavka 1, se registracije na podlagi odstavka 2 za zdravila rastlinskega izvora, ki vsebujejo to snov, prekličejo, razen če se v treh mesecih ne predložijo podatki in listine iz člena 16c(1).	If a herbal substance, preparation or a combination thereof ceases to be included in the list referred to in paragraph 1, registrations pursuant to paragraph 2 for herbal medicinal products containing this substance shall be revoked unless the particulars and documents referred to in Article 16c(1) are submitted within three months.
Člen 16g	Article 16g
▼M10	▼M10
1.	1.
Za registracijo zaradi tradicionalne uporabe, odobreno na podlagi tega poglavja, se po analogiji uporabljajo člen 3(1) in (2), člen 4(4), člen 6(1), člen 12, člen 17(1), členi 19, 20, 23, 24, 25, 40 do 52, 70 do 85, 101 do 108b, člen 111(1) in (3), členi 112, 116, 117, 118, 122, 123, 125, drugi odstavek člena 126 in člen 127 te direktive in tudi Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju ( 9 ).	Article 3(1) and (2), Article 4(4), Article 6(1), Article 12, Article 17(1), Articles 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108b, Article 111(1) and (3), Articles 112, 116, 117, 118, 122, 123, 125, the second paragraph of Article 126, and Article 127 of this Directive as well as Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use ( 9 ) shall apply, by analogy, to traditional-use registration granted under this Chapter.
▼M3	▼M3
2.	2.
Poleg zahtev členov 54 do 65 mora ovojnina in navodilo za uporabo vsebovati navedbo, da:	In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that:
(a)	(a)
je zdravilo tradicionalno zdravilo rastlinskega izvora za uporabo za določene terapevtske indikacije izključno na podlagi dolgotrajne uporabe; in	the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and
(b)	(b)
naj se uporabnik posvetuje z zdravnikom ali usposobljenim strokovnjakom za zdravstveno varstvo, če med uporabo zdravila simptomi še naprej vztrajajo ali če se pojavijo škodljivi neželeni učinki, ki niso navedeni v navodilu za uporabo.	the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
Država članica lahko zahteva, da je na ovojnini in v navodilih za uporabo navedena tudi vrsta zadevne tradicije.	A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question.
3.	3.
Poleg zahtev členov 86 do 99 mora vsako oglaševanje zdravila, registriranega v skladu s tem poglavjem, vsebovati naslednjo izjavo: Tradicionalno zdravilo rastlinskega izvora za uporabo za določene terapevtske indikacije, izključno na podlagi dolgotrajne uporabe.	In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use.
Člen 16h	Article 16h
1.	1.
Ustanovi se Odbor za zdravila rastlinskega izvora. Odbor je del Agencije in ima naslednje pristojnosti:	A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence:
(a)	(a)
glede poenostavljenih registracij:	as regards simplified registrations, to:
—	—
opravlja naloge, ki izhajajo iz člena 16c(1) in (4),	perform the tasks arising from Article 16c(1) and (4),
—	—
opravlja naloge, ki izhajajo iz člena 16d,	perform the tasks arising from Article 16d,
—	—
pripravi osnutek seznama rastlinskih snovi, pripravkov in kombinacij iz njih, kakor je navedeno v členu 16f(1), in	prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and
—	—
pripravi monografije Skupnosti za zdravila rastlinskega izvora, kakor je navedeno v odstavku 3 tega člena;	establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article;
(b)	(b)
glede dovoljenj za promet z zdravili rastlinskega izvora pripravi rastlinske monografije Skupnosti za zdravila rastlinskega izvora, kakor je navedeno v odstavku 3 tega člena;	as regards authorisations of herbal medicinal products, to establish Community herbal monographs for herbal medicinal products, as referred to in paragraph 3 of this Article;
(c)	(c)
glede posredovanj Agenciji v skladu s poglavjem 4 naslova III, v zvezi z zdravili rastlinskega izvora, kakor so navedena v členu 16a, opravlja naloge, določene v členu 32;	as regards referrals to the Agency under Chapter 4 of Title III, in relation to herbal medicinal products as referred to in Article 16a, to perform the tasks set out in Article 32;
(d)	(d)
kadar so v skladu s poglavjem 4 naslova III na Agencijo posredovana kakršna koli druga zdravila, ki vsebujejo rastlinske snovi, kadar je to primerno, daje mnenje o rastlinski snovi.	where other medicinal products containing herbal substances are referred to the Agency under Chapter 4 of Title III, to give an opinion on the herbal substance where appropriate.
Odbor za zdravila rastlinskega izvora opravlja kakršne koli druge naloge, ki jih nanj prenese zakonodaja Skupnosti.	Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law.
Ustrezna koordinacija z Odborom za zdravila za ljudi se zagotovi s postopkom, ki ga določi izvršni direktor Agencije v skladu s členom 57(2) Uredbe (EGS) 2309/93.	The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 57(2) of Regulation (EEC) No 2309/93.
2.	2.
Vsaka država članica za triletni mandat, ki se lahko podaljša, imenuje v Odbor za zdravila rastlinskega izvora enega člana in enega namestnika.	Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products.
Namestniki zastopajo in glasujejo za člane, ko so le-ti odsotni. Člani in namestniki so izbrani za svojo vlogo in izkušnje pri ovrednotenju zdravil rastlinskega izvora in zastopajo pristojne nacionalne organe.	The alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities.
Navedeni odbor lahko kooptira največ pet dodatnih članov, ki so izbrani na podlagi posebne znanstvene usposobljenosti. Ti člani se imenujejo za triletni mandat, ki se lahko podaljša, in nimajo namestnikov.	The said Committee may coopt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
Zaradi kooptiranja takih članov navedeni odbor ugotovi posebno dopolnilno znanstveno usposobljenost dodatnega člana (članov). Kooptirane člane se izbere med strokovnjaki, ki jih predlagajo države članice ali Agencija.	With a view to the coopting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Coopted members shall be chosen among experts nominated by Member States or the Agency.
Člane navedenega odbora lahko spremljajo strokovnjaki na posebnih znanstvenih ali tehničnih področjih.	The members of the said Committee may be accompanied by experts in specific scientific or technical fields.
3.	3.
Odbor za zdravila rastlinskega izvora pripravi rastlinske monografije Skupnosti za zdravila rastlinskega izvora v zvezi z uporabo člena 10(1)(a)(ii) in tudi tradicionalna zdravila rastlinskega izvora. Navedeni odbor izpolnjuje odgovornosti, ki jih ima po določbah tega poglavja in na podlagi druge zakonodaje Skupnosti.	The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law.
Ko so rastlinske monografije v smislu tega odstavka pripravljene, jih države članice upoštevajo pri pregledovanju vloge. Kadar taka rastlinska monografija Skupnosti še ni pripravljena, se lahko sklicujejo na druge ustrezne monografije, objave ali podatke.	When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to.
Kadar se pripravijo nove rastlinske monografije Skupnosti, mora imetnik registracije preučiti, ali je treba skladno spremeniti dokumentacijo o registraciji. Imetnik registracije mora pristojni organ zadevne države članice obvestiti o kakršnikoli taki spremembi.	When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned.
Rastlinske monografije se objavijo.	The herbal monographs shall be published.
4.	4.
Splošne določbe Uredbe (EGS) št. 2309/93, ki se nanašajo na Odbor za zdravila za ljudi, se po analogiji uporabljajo za Odbor za zdravila rastlinskega izvora.	The general provisions of Regulation (EEC) No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products.
Člen 16i	Article 16i
Komisija pred 30. aprilom 2007 Evropskemu parlamentu in Svetu predloži poročilo o uporabi določb tega poglavja.	Before 30 April 2007, the Commission shall submit a report to the European Parliament and to the Council concerning the application of the provisions of this chapter.
Poročilo vključuje oceno možne razširitve registracije zaradi tradicionalne uporabe na druge skupine zdravil.	The report shall include an assessment on the possible extension of traditional-use registration to other categories of medicinal products.
▼B	▼B
POGLAVJE 3	CHAPTER 3
Postopki za pridobitev dovoljenja za promet z zdravilom	Procedures relevant to the marketing authorization
▼M4	▼M4
Člen 17	Article 17
1.	1.
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da se postopek za pridobitev dovoljenja za promet z zdravilom zaključi v 210 dneh od predložitve popolne vloge.	Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days after the submission of a valid application.
Vloge za dovoljenje za promet z zdravilom v dveh ali več državah članicah za isto zdravilo se vložijo v skladu s ►M10 členi 28 ◄ do 39.	Applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with ►M10 Articles 28 ◄ to 39.
2.	2.
Kadar država članica ugotovi, da se vloga za pridobitev dovoljenja za promet za isto zdravilo že obravnava v drugi državi članici, zadevna država članica prekine obravnavo vloge in svetuje predlagatelju, da ravna v skladu s ►M10 členi 28 ◄ do 39.	Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that ►M10 Articles 28 ◄ to 39 apply.
Člen 18	Article 18
Kadar je država članica v skladu s členom 8(3)(1) obveščena, da je druga država članica izdala dovoljenje za promet z zdravilom, ki je predmet vloge za pridobitev dovoljenja za promet v zadevni državi članici, ta država zavrne vlogo, razen če je bila ta vložena v skladu s ►M10 členi 28 ◄ do 39.	Where a Member State is informed in accordance with Article 8(3)(1) that another Member State has authorised a medicinal product which is the subject of a marketing authorisation application in the Member State concerned, it shall reject the application unless it was submitted in compliance with ►M10 Articles 28 ◄ to 39.
▼M16	▼M16
Člen 18a	Article 18a
1.	1.
Z odstopanjem od člena 17(1), drugi pododstavek, člena 17(2) in člena 18, če je vloga za pridobitev dovoljenja za promet vložena v eni ali več državah članicah in v Združenem kraljestvu v zvezi s Severno Irsko ali če je vloga za pridobitev dovoljenja za promet vložena v Združenem kraljestvu v zvezi s Severno Irsko za zdravilo, ki se že pregleduje ali je že bilo odobreno v državi članici, vloge za Združeno kraljestvo v zvezi s Severno Irsko ni treba vložiti v skladu s členi 28 do 39, če so izpolnjeni vsi naslednji pogoji:	By way of derogation from Article 17(1), second subparagraph, Article 17(2) and Article 18, if an application for marketing authorisation is submitted in one or more Member States and in the United Kingdom in respect of Northern Ireland, or if an application for marketing authorisation is submitted in the United Kingdom in respect of Northern Ireland for a medicinal product which is already being examined or has already been authorised in a Member State, the application regarding the United Kingdom in respect of Northern Ireland shall not have to be submitted in accordance with Articles 28 to 39 provided that all of the following conditions are fulfilled:
(a)	(a)
dovoljenje za promet za Združeno kraljestvo v zvezi s Severno Irsko izda pristojni organ za Združeno kraljestvo v zvezi s Severno Irsko v skladu s pravom Unije, takšna skladnost s pravom Unije pa je zagotovljena v obdobju veljavnosti tega dovoljenja za promet;	the marketing authorisation for the United Kingdom in respect of Northern Ireland is granted by the competent authority for the United Kingdom in respect of Northern Ireland in compliance with Union law, and such compliance with Union law is ensured during the period of validity of that marketing authorisation;
(b)	(b)
zdravila, ki jih je pristojni organ odobril za Združeno kraljestvo v zvezi s Severno Irsko, so na voljo bolnikom ali končnim potrošnikom samo na ozemlju Severne Irske in niso na voljo v nobeni državi članici.	the medicinal products authorised by the competent authority for the United Kingdom in respect of Northern Ireland are made available to patients or end-consumers only in the territory of Northern Ireland, and they are not made available in any Member State.
2.	2.
Imetniku dovoljenja za promet z zdravilom, za katero je bilo dovoljenje za promet za Združeno kraljestvo v zvezi s Severno Irsko že izdano v skladu s členi 28 do 39 pred 20. aprilom 2022, se dovoli umik dovoljenja za promet za Združeno kraljestvo v zvezi s Severno Irsko iz postopka z medsebojnim priznavanjem ali decentraliziranega postopka ter vložitev vloge za dovoljenje za promet za to zdravilo pri pristojnih organih Združenega kraljestva v zvezi s Severno Irsko v skladu z odstavkom 1.	The marketing authorisation holder of a medicinal product for which a marketing authorisation has already been granted for the United Kingdom in respect of Northern Ireland in accordance with Articles 28 to 39 before 20 April 2022 shall be allowed to withdraw the marketing authorisation for the United Kingdom in respect of Northern Ireland from the mutual recognition or the decentralised procedure and to submit an application for a marketing authorisation for that medicinal product to the competent authorities of the United Kingdom with respect to Northern Ireland in accordance with paragraph 1.
▼B	▼B
Člen 19	Article 19
Za preučitev vloge, predložene v skladu s ►M4 členi 8, 10, 10a, 10b in 10c ◄ , pristojni organ države članice:	In order to examine the application submitted in accordance with ►M4 Articles 8, 10, 10a, 10b and 10c ◄ , the competent authority of the Member State:
1.	1.
mora preveriti, ali so podrobni podatki, predloženi v vlogi, v skladu s ►M4 členi 8, 10, 10a, 10b in 10c, ◄ in preučiti, če so izpolnjeni pogoji za izdajo dovoljenja za dajanje zdravila v promet (dovoljenje za promet z zdravilom).	must verify whether the particulars submitted in support of the application comply with the said ►M4 Articles 8, 10, 10a, 10b and 10c ◄ and examine whether the conditions for issuing an authorization to place medicinal products on the market (marketing authorization) are complied with.
2.	2.
lahko zdravilo, njegove vhodne snovi, in če je potrebno, vmesne spojine ali druge sestavine predloži v preskušanje ►M4 Uradnemu kontrolnemu laboratoriju za analizno preskušanje zdravil ali laboratoriju, ki ga je za ta namen pooblastila država članica ◄ , da se zagotovi, da so kontrolne metode, ki jih je uporabil proizvajalec in so opisane v podrobnih podatkih vloge, zadovoljive in v skladu s členom 8(3)(h).	may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, for testing by ►M4 an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose ◄ in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with Article 8(3)(h) are satisfactory.
3.	3.
lahko zahteva od vlagatelja, kadar je to primerno, da dopolni podrobne podatke v vlogi glede postavk iz ►M4 členov 8(3), 10, 10a, 10b in 10c ◄ . Če pristojni organ izkoristi to možnost, časovni roki iz člena 17 začasno prenehajo teči do predložitve zahtevanih dodatnih informacij. Prav tako časovni roki prenehajo teči za čas, ki ga vlagatelj potrebuje, kadar je to primerno, za ustno ali pisno obrazložitev.	may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the ►M4 Articles 8(3), 10, 10a, 10b and 10c ◄ . Where the competent authority avails itself of this option, the time limits laid down in Article 17 shall be suspended until such time as the supplementary information required has been provided. Likewise, these time limits shall be suspended for the time allowed the applicant, where appropriate, for giving oral or written explanation.
Člen 20	Article 20
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo:	Member States shall take all appropriate measures to ensure that:
(a)	(a)
da pristojni organi preverijo, da so proizvajalci in uvozniki zdravil iz tretjih držav sposobni proizvajati zdravilo v skladu s podrobnimi podatki, predloženimi po členu 8(3)(d) in/ali izvajati kontrole po metodah, opisanih v podrobnih podatkih vloge, v skladu s členom 8(3)(h);	the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to Article 8(3)(d), and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with Article 8(3)(h);
(b)	(b)
da pristojni organi lahko dovolijo proizvajalcem in uvoznikom zdravil iz tretjih držav, da ►M4 v utemeljenih primerih ◄ določene faze proizvodnje in/ali določene kontrole iz točke (a) izvedejo tretje osebe; v takih primerih se preverjanje s strani pristojnih organov opravi v pooblaščeni ustanovi.	the competent authorities may allow manufacturers and importers of medicinal products coming from third countries, ►M4 in justifiable cases ◄ , to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties; in such cases, the verifications by the competent authorities shall also be made in the establishment designated.
▼M16	▼M16
V zvezi s preskušanjem z namenom kontrole kakovosti, ki se izvaja v delih Združenega kraljestva razen Severne Irske, v zvezi z zdravili, vključenimi na seznam iz člena 127d, razen tistih, ki jih je odobrila Komisija, lahko pristojni organi Združenega kraljestva v zvezi s Severno Irsko in do 31. decembra 2024 pristojni organi Cipra, Irske in Malte štejejo, da obstaja utemeljen primer v smislu prvega odstavka, točka (b), ne da bi opravili oceno za vsak primer posebej, pod pogojem, da:	With regard to quality control testing carried out in parts of the United Kingdom other than Northern Ireland regarding medicinal products included in the list referred to in Article 127d other than those authorised by the Commission, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta may consider that there is a justifiable case within the meaning of point (b) of the first paragraph, without carrying out a case-by-case assessment provided that:
(a)	(a)
vsako serijo zadevnih zdravil sprosti usposobljena oseba na mestu v Uniji ali na Severnem Irskem ali usposobljena oseba na mestu v delih Združenega kraljestva razen Severne Irske, ki uporablja standarde kakovosti, enakovredne tistim iz člena 51;	each batch of the medicinal products concerned is released by a qualified person on a site in the Union or in Northern Ireland or by a qualified person on a site in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in Article 51;
(b)	(b)
je ustanova, ki jo je določila tretja stran, ki izvaja preskušanje z namenom kontrole kakovosti, pod nadzorom pristojnega organa Združenega kraljestva, vključno z izvajanjem pregledov na kraju samem;	the establishment designated by the third party conducting the quality control testing is supervised by the competent authority of the United Kingdom, including by performing on-the-spot checks;
(c)	(c)
kadar sprostitev serije izvede usposobljena oseba, ki prebiva in deluje v delih Združenega kraljestva razen Severne Irske, imetnik dovoljenja za proizvodnjo izjavi, da dne 20. aprila 2022 nima na voljo usposobljene osebe, ki prebiva in deluje v Uniji.	where the batch release is carried out by a qualified person who resides and operates in parts of the United Kingdom other than Northern Ireland, the manufacturing authorisation holder declares that it does not have at its disposal a qualified person who resides and operates in the Union on 20 April 2022.
▼B	▼B
Člen 21	Article 21
1.	1.
Ko pristojni organ zadevne države članice izda dovoljenje za promet z zdravilom, imetnika dovoljenja obvesti o povzetku glavnih značilnosti zdravila, kot ga je organ odobril.	When the marketing authorization is issued, the holder shall be informed, by the competent authorities of the Member State concerned, of the summary of the product characteristics as approved by it.
2.	2.
Pristojni organi sprejmejo vse potrebne ukrepe, da zagotovijo, da so podatki v povzetku skladni s sprejetimi ob izdaji dovoljenja za promet z zdravilom ali pozneje.	The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently.
▼M10	▼M10
3.	3.
Pristojni nacionalni organi nemudoma dajo na voljo javnosti dovoljenje za promet z zdravilom skupaj z navodilom za uporabo in povzetkom glavnih značilnosti zdravila ter pogoji, določenimi v skladu s členi 21a, 22 in 22a, skupaj z roki za izpolnitev teh pogojev za vsako zdravilo, ki so jo odobrili.	The national competent authorities shall, without delay, make publicly available the marketing authorisation together with the package leaflet, the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for the fulfilment of those conditions for each medicinal product which they have authorised.
4.	4.
Pristojni nacionalni organi pripravijo poročilo o oceni in pripombe na dokumentacijo v zvezi z rezultati farmacevtskih in predkliničnih preskusov ter kliničnih preskušanj ter sistema obvladovanja tveganj in sistema farmakovigilance zadevnega zdravila. Poročilo o oceni se dopolni vedno, ko so na voljo novi podatki, ki so pomembni za vrednotenje kakovosti, varnosti ali učinkovitosti zadevnega zdravila.	The national competent authorities shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is important for the evaluation of the quality, safety or efficacy of the medicinal product concerned.
Pristojni nacionalni organi nemudoma dajo na voljo javnosti poročilo o oceni skupaj z razlogi za svoje mnenje, po izbrisu vseh podatkov poslovno zaupne narave. Utemeljitev se predloži ločeno za vsako indikacijo, za katero se zaprosi.	The national competent authorities shall make the assessment report publicly accessible without delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for.
Javno poročilo o oceni vključuje povzetek, pisan tako, da je razumljiv javnosti. Povzetek vsebuje zlasti del, ki se nanaša na pogoje uporabe zdravila.	The public assessment report shall include a summary written in a manner that is understandable to the public. The summary shall contain, in particular, a section relating to the conditions of use of the medicinal product.
▼M10	▼M10
Člen 21a	Article 21a
Poleg določb iz člena 19 se dovoljenje za promet z zdravilom lahko izda, če je izpolnjen eden ali več naslednjih pogojev:	In addition to the provisions laid down in Article 19, a marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions:
(a)	(a)
izvedba nekaterih ukrepov za zagotovitev varne uporabe zdravila, ki se vključi v sistem obvladovanja tveganj;	to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;
(b)	(b)
izvedba študij o varnosti zdravila po pridobitvi dovoljenja za promet;	to conduct post-authorisation safety studies;
(c)	(c)
izpolnjevanje obveznosti evidentiranja ali poročanja o domnevnih neželenih učinkih, ki so strožje od zahtev iz naslova IX;	to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Title IX;
(d)	(d)
drugi pogoji ali omejitve glede varne in učinkovite uporabe zdravila;	any other conditions or restrictions with regard to the safe and effective use of the medicinal product;
(e)	(e)
obstoj ustreznega sistema farmakovigilance;	the existence of an adequate pharmacovigilance system;
(f)	(f)
opravljanje študij učinkovitosti po pridobitvi dovoljenja, v katerih se opredelijo nekatera vprašanja o učinkovitosti zdravila in se nanje lahko odgovori le po tem, ko je zdravilo bilo dano na trg. Obveznost opravljanja študij sledi delegiranim aktom, sprejetim v skladu s členom 22b ob upoštevanju znanstvenih smernic iz člena 108a.	to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.
Dovoljenje za promet z zdravilom določa roke za izpolnitev teh pogojev, kadar je to potrebno.	The marketing authorisation shall lay down deadlines for the fulfilment of these conditions where necessary.
▼M10	▼M10
Člen 22	Article 22
V izjemnih okoliščinah in po posvetu s predlagateljem se dovoljenje za promet z zdravilom lahko izda pod določenimi pogoji, predvsem v zvezi z varnostjo zdravila, uradnim obveščanjem pristojnih nacionalnih organov o vseh dogodkih v zvezi z uporabo zdravila ter potrebnimi ukrepi.	In exceptional circumstances and following consultation with the applicant, the marketing authorisation may be granted subject to certain conditions, in particular relating to the safety of the medicinal product, notification to the national competent authorities of any incident relating to its use, and action to be taken.
Dovoljenje za promet z zdravilom se lahko izda samo, če vlagatelj lahko dokaže, da ne more predložiti obširnih podatkov o učinkovitosti in varnosti zdravila v običajnih pogojih uporabe zaradi objektivnih in preverljivih razlogov, ki morajo temeljiti na enem od razlogov iz Priloge I.	The marketing authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and must be based on one of the grounds set out in Annex I.
Podaljšanje dovoljenja za promet z zdravilom je vezano na vsakoletno ponovno oceno teh pogojev.	Continuation of the marketing authorisation shall be linked to the annual reassessment of these conditions.
▼M10	▼M10
Člen 22a	Article 22a
1.	1.
Po izdaji dovoljenja za promet z zdravilom lahko pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom naloži obveznost:	After the granting of a marketing authorisation, the national competent authority may impose an obligation on the marketing authorisation holder:
(a)	(a)
izvedbe študije o varnosti zdravila po pridobitvi dovoljenja za promet, če obstajajo skrbi glede tveganj zdravila, ki je pridobilo dovoljenje za promet. Če se iste varnostne zahteve uporabljajo za več kot eno zdravilo, pristojni nacionalni organ po posvetu z Odborom za ocenjevanje tveganja na področju farmakovigilance pozove zadevne imetnike dovoljenj za promet z zdravilom, naj opravijo skupno študijo o varnosti zdravila po pridobitvi dovoljenja za promet;	to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the national competent authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;
(b)	(b)
izvedbe študije učinkovitosti po pridobitvi dovoljenja, ko razumevanje bolezni ali klinična metodologija nakazujeta, da bi se predhodne ocene učinkovitosti lahko bistveno spremenile. Obveznost izvedbe študije o učinkovitosti po pridobitvi dovoljenja za promet temelji na delegiranih aktih, sprejetih v skladu s členom 22b, ob upoštevanju znanstvenih smernic iz člena 108a.	to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly. The obligation to conduct the post-authorisation efficacy study shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.
Naložitev te obveznosti se ustrezno utemelji in se pisno uradno sporoči, ter vsebuje cilje in časovni okvir za predložitev in izvedbo študije.	The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study.
2.	2.
Pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom da možnost, da predloži pisna pojasnila kot odgovor na naložitev obveznosti v roku, ki ga določi organ, če imetnik dovoljenja za promet z zdravilom to zahteva v 30 dneh od prejema pisnega uradnega obvestila o obveznosti.	The national competent authority shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.
3.	3.
Pristojni nacionalni organ na podlagi pisnih pojasnil, ki jih predloži imetnik dovoljenja za promet z zdravilom, umakne ali potrdi obveznost. Kadar pristojni nacionalni organ potrdi obveznost, se dovoljenje za promet z zdravilom spremeni tako, da se obveznost vključi kot pogoj dovoljenja za promet z zdravilom, sistem obvladovanja tveganj pa se ustrezno posodobi.	On the basis of the written observations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the obligation. Where the national competent authority confirms the obligation, the marketing authorisation shall be varied to include the obligation as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Člen 22b	Article 22b
1.	1.
Da bi določili razmere, v katerih je treba zahtevati izvedbo študije o učinkovitosti po pridobitvi dovoljenja na podlagi člena 21a in člena 22a te direktive, lahko Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme ukrepe, ki dopolnjujejo določbe členov 21a in 22a.	In order to determine the situations in which post-authorisation efficacy studies may be required under Articles 21a and 22a of this Directive, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions of Articles 121b and 121c, measures supplementing the provisions in Articles 21a and 22a.
2.	2.
Komisija pri sprejemanju teh delegiranih aktov ravna v skladu z določbami te direktive.	When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Directive.
Člen 22c	Article 22c
1.	1.
Od imetnika dovoljenja za promet z zdravilom se zahteva, da v sistem obvladovanja tveganj vključi vse pogoje iz členov 21a, 22 ali 22a.	The marketing authorisation holder shall incorporate any conditions referred to in Articles 21a, 22 or 22a in his risk management system.
2.	2.
Države članice obvestijo Agencijo o dovoljenjih za promet z zdravilom, ki so jih izdale ob upoštevanju pogojev iz členov 21a, 22 ali 22a.	The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to Articles 21a, 22 or 22a.
▼M10	▼M10
Člen 23	Article 23
1.	1.
Po izdaji dovoljenja za promet imetnik dovoljenja za promet z zdravilom glede postopkov proizvodnje in nadzora, predpisanih v točkah (d) in (h) členu 8(3), upošteva znanstveni in tehnični napredek in uvede vse zahtevane spremembe, da bi omogočil proizvodnjo in preverjanje zdravila po splošno sprejetih znanstvenih postopkih.	After a marketing authorisation has been granted, the marketing authorisation holder shall, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Te spremembe odobri pristojni organ zadevne države članice.	Those changes shall be subject to the approval of the competent authority of the Member State concerned.
2.	2.
Imetnik dovoljenja za promet z zdravilom nemudoma pošlje pristojnemu nacionalnemu organu vsakršne nove informacije, ki bi lahko privedle do spremembe podatkov ali dokumentov iz člena 8(3), členov 10, 10a, 10b in 11 ali člena 32(5) ali Priloge I.	The marketing authorisation holder shall forthwith provide the national competent authority with any new information which might entail the amendment of the particulars or documents referred to in Article 8(3), Articles 10, 10a, 10b and 11, or Article 32(5), or Annex I.
Zlasti pa imetnik dovoljenja za promet z zdravilom nemudoma obvesti pristojni nacionalni organ o vseh prepovedih ali omejitvah, ki so jih uvedli pristojni organi katere koli države, v kateri je zdravilo v prometu in o kakršnih koli drugih novih informacijah, ki bi lahko vplivale na oceno koristi in tveganj zadevnega zdravila. Informacije vključujejo pozitivne in negativne rezultate kliničnih preskušanj ali drugih študij za vse indikacije in populacije, ne glede na to, ali so vključene v dovoljenje za promet z zdravilom ali ne, ter podatke o uporabi zdravila, kadar je takšna uporaba izven okvira pogojev dovoljenja za promet z zdravilom.	In particular, the marketing authorisation holder shall forthwith inform the national competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned. The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.
3.	3.
Imetnik dovoljenja za promet z zdravilom zagotovi, da se informacije o zdravilu sproti dopolnijo z novimi znanstvenimi spoznanji, vključno s sklepi o oceni in priporočili, objavljenimi na evropskem spletnem portalu o zdravilih, vzpostavljenem v skladu s členom 26 Uredbe (ES) št. 726/2004.	The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
4.	4.
Da bi se lahko razmerje med tveganjem in koristjo stalno ocenjevalo lahko pristojni nacionalni organ od imetnika dovoljenja za promet z zdravilom kadar koli zahteva, da posreduje podatke, ki dokazujejo, da razmerje med tveganjem in koristjo ostaja ugodno. Imetnik dovoljenja za promet z zdravilom v celoti in takoj ugodi vsaki taki zahtevi.	In order to be able to continuously assess the risk-benefit balance, the national competent authority may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable. The marketing authorisation holder shall answer fully and promptly any such request.
Pristojni nacionalni organ lahko od imetnika dovoljenja za promet z zdravilom kadar koli zahteva, da predloži izvod glavnega dosjeja o sistemu farmakovigilance. Imetnik dovoljenja za promet z zdravilom izvod predloži najkasneje v sedmih dneh po prejetju zahtevka.	The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file. The marketing authorisation holder shall submit the copy at the latest 7 days after receipt of the request.
▼M4	▼M4
Člen 23a	Article 23a
Po izdaji dovoljenja za promet z zdravilom imetnik dovoljenja za promet pristojnemu organu države članice, ki je dovoljenje izdala, sporoči datum začetka dejanskega prometa z zdravilom za uporabo v humani medicini v tej državi članici, in pri tem upošteva različne odobrene oblike pakiranj.	After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of actual marketing of the medicinal product for human use in that Member State, taking into account the various presentations authorised.
▼M12	▼M12
Če zdravilo ni več dano v promet v državi članici, bodisi začasno ali stalno, imetnik dovoljenja za promet obvesti pristojni organ zadevne države članice. Razen v izjemnih okoliščinah se tako obvestilo pošlje najmanj dva meseca pred prekinitvijo dajanja zdravila v promet. Imetnik dovoljenja za promet pristojni organ obvesti o razlogih za tako ukrepanje v skladu s členom 123(2).	If the product ceases to be placed on the market of a Member State, either temporarily or permanently, the marketing authorisation holder shall notify the competent authority of that Member State. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the competent authority of the reasons for such action in accordance with Article 123(2).
▼M4	▼M4
Na zahtevo pristojnega organa, predvsem v smislu farmakovigilance, imetnik dovoljenja za promet z zdravilom pristojnemu organu predloži vse podatke v zvezi z obsegom prodaje zdravila ter vse razpoložljive podatke v zvezi s številom izdanih receptov.	Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, and any data in his possession relating to the volume of prescriptions.
▼M8	▼M8
Člen 23b	Article 23b
▼M14	▼M14
1.	1.
Spremembe se razvrstijo v različne skupine, odvisno od ravni tveganja za javno zdravje ter morebitnega vpliva na kakovost, varnost in učinkovitost zadevnega zdravila. Te skupine zajemajo vse od sprememb pogojev za dovoljenje za promet z zdravilom, pri katerih je možnost vpliva na kakovost, varnost ali učinkovitost zdravila največja, do sprememb, ki na zdravilo nimajo nobenega vpliva ali pa je ta minimalen.	Variations shall be classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicinal product concerned. Those categories shall range from changes to terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon.
2.	2.
Postopki za pregled vlog za spremembe so sorazmerni s povezanim tveganjem in vplivom. Ti postopki vključujejo tako postopke, ki omogočajo izvajanje šele po odobritvi na podlagi popolne znanstvene ocene, kot tudi postopke, ki omogočajo takojšnje izvajanje in naknadno obvestilo imetnika dovoljenja za promet pristojnemu organu.	The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority.
2a.	2a.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za dopolnitev te direktive v zvezi z:	The Commission is empowered to adopt delegated acts in accordance with Article 121a in order to supplement this Directive by:
(a)	(a)
določitvijo skupin, v katere se razvrščajo spremembe, in	specifying the categories in which variations shall be classified; and
(b)	(b)
določitvijo postopkov za pregled vlog za spremembe pogojev dovoljenj za promet z zdravilom.	establishing procedures for the examination of applications for variations to the terms of marketing authorisations.
3.	3.
Pri sprejemanju delegiranih aktov iz tega člena si Komisija prizadeva za možnost predložitve enotne vloge za eno ali več enakih sprememb pogojev različnih dovoljenj za promet z zdravilom.	When adopting the delegated acts referred to in this Article, the Commission shall endeavour to make possible the submission of a single application for one or more identical changes made to the terms of different marketing authorisations.
4.	4.
Države članice lahko še naprej uporabljajo nacionalne določbe o spremembah, ki veljajo na dan začetka veljavnosti Uredbe Komisije (ES) št. 1234/2008 ( 10 ), za dovoljenja za promet, izdana pred 1. januarjem 1998 za zdravila, za katera je bilo izdano dovoljenje le v tej državi članici. Kadar se za zdravilo, za katerega veljajo nacionalne določbe v skladu s tem členom, naknadno izda dovoljenje za promet v drugi državi članici, velja zanj od tega datuma naprej Uredba (ES) št. 1234/2008.	A Member State may continue to apply national provisions on variations applicable at the time of entry into force of Commission Regulation (EC) No 1234/2008 ( 10 ) to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State. Where a medicinal product subject to national provisions in accordance with this Article is subsequently granted a marketing authorisation in another Member State, Regulation (EC) No 1234/2008 shall apply to that medicinal product from that date.
▼M8	▼M8
5.	5.
Kadar se država članica odloči, da bo še naprej uporabljala nacionalne določbe na podlagi odstavka 4, o tem obvesti Komisijo. Če Komisije ne obvesti do 20. januarja 2011, se uporablja ►M14 Regulation (EC) No 1234/2008 ◄ .	Where a Member State decides to continue to apply national provisions pursuant to paragraph 4, it shall notify the Commission thereof. If a notification has not been made by 20 January 2011, ►M14 Regulation (EC) No 1234/2008 ◄ shall apply.
▼M4	▼M4
Člen 24	Article 24
1.	1.
Brez vpliva na odstavka 4 in 5, dovoljenje za promet z zdravilom velja pet let.	Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years.
2.	2.
Dovoljenje za promet se lahko podaljša po petih letih na podlagi ponovne ocene razmerja med tveganji in koristmi, ki jo opravi pristojni organ države članice, ki dovoljenje izda.	The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority of the authorising Member State.
▼M10	▼M10
V ta namen imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži konsolidirano različico dokumentacije glede kakovosti, varnosti in učinkovitosti, vključno z oceno podatkov iz poročil o domnevnih neželenih učinkih in rednih posodobljenih poročil o varnosti, predloženih v skladu z naslovom IX, in z vsemi spremembami, ki so bile uvedene od izdaje dovoljenja za promet z zdravilom, najmanj devet mesecev pred datumom izteka veljavnosti dovoljenja za promet z zdravilom v skladu z odstavkom 1.	To this end, the marketing authorisation holder shall provide the national competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including the evaluation of data contained in suspected adverse reactions reports and periodic safety update reports submitted in accordance with Title IX, and information on all variations introduced since the marketing authorisation was granted, at least 9 months before the marketing authorisation ceases to be valid in accordance with paragraph 1.
3.	3.
Ko je dovoljenje za promet podaljšano, velja za nedoločen čas, razen če se pristojni nacionalni organ iz upravičenih razlogov v zvezi s farmakovigilanco, vključno z nezadostnim številom izpostavljenih bolnikov zadevnemu zdravilu, odloči, da nadaljuje z dodatnim petletnim obnovitvenim obdobjem v skladu z odstavkom 2.	Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal in accordance with paragraph 2.
▼M4	▼M4
4.	4.
Vsako dovoljenje za promet z zdravilom, ki mu v treh letih od izdaje ne sledi dejansko dajanje odobrenega zdravila na trg države članice, ki je dovoljenje izdala, preneha veljati.	Any authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product in the authorising Member State shall cease to be valid.
5.	5.
Če zdravilo, za katero je izdano dovoljenje za promet in ki je bilo predhodno dano v promet v državi članici, ki je dovoljenje izdala, ni več na trgu v obdobju treh zaporednih let, dovoljenje za to zdravilo preneha veljati.	When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.
6.	6.
Pristojni organ lahko v izjemnih okoliščinah in v interesu javnega zdravja odobri izjeme od odstavkov 4 in 5. Take izjeme morajo biti ustrezno utemeljene.	The competent authority may, in exceptional circumstances and on public health grounds grant exemptions from paragraphs 4 and 5. Such exemptions must be duly justified.
▼B	▼B
Člen 25	Article 25
Dovoljenje za promet ne vpliva na civilno in kazensko odgovornost proizvajalca, in kadar je to primerno, imetnika dovoljenja za promet z zdravilom.	Authorization shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the marketing authorization holder.
▼M4	▼M4
Člen 26	Article 26
1.	1.
Dovoljenje za promet z zdravilom se zavrne, če se po preverjanju podrobnih podatkov in dokumentov, navedenih v členih 8, 10, 10a, 10b in 10c dokaže, da:	The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, it is clear that:
(a)	(a)
razmerje med tveganji in koristmi zdravila ni ugodno; ali	the risk-benefit balance is not considered to be favourable; or
(b)	(b)
predlagatelj terapevtske učinkovitosti ni zadovoljivo podprl z dokazi; ali	its therapeutic efficacy is insufficiently substantiated by the applicant; or
(c)	(c)
kakovostna in količinska sestava zdravila ne ustreza deklarirani.	its qualitative and quantitative composition is not as declared.
2.	2.
Dovoljenje za promet se zavrne tudi, če v podporo vloge predloženi podrobni podatki ali dokumenti niso skladni s členi 8, 10, 10a, 10b in 10c.	Authorisation shall likewise be refused if any particulars or documents submitted in support of the application do not comply with Articles 8, 10, 10a, 10b and 10c.
3.	3.
Predlagatelj ali imetnik dovoljenja za promet z zdravilom je odgovoren za točnost dokumentov in predloženih podatkov.	The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and the data submitted.
▼M10 —————	▼M10 —————
▼M4	▼M4
Člen 27	Article 27
▼M10	▼M10
1.	1.
Ustanovi se skupina za usklajevanje za naslednje namene:	A coordination group shall be set up for the following purposes:
(a)	(a)
preučevanje vseh vprašanj, povezanih s pridobitvijo dovoljenj za promet z zdravilom v dveh ali več državah članicah v skladu s postopki, določenimi v poglavju 4;	the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4;
(b)	(b)
preučevanje vseh vprašanj, povezanih s farmakovigilanco zdravil, ki jih odobrijo države članice, v skladu s členi 107c, 107e, 107g, 107k in 107q;	the examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107k and 107q;
(c)	(c)
preučevanje vseh vprašanj, povezanih s spremembami dovoljenj za promet z zdravilom, ki jih izdajo države članice, v skladu s členom 35(1).	the examination of questions relating to variations of marketing authorisations granted by the Member States, in accordance with Article 35(1).
Agencija zagotovi sekretariat za to skupino za usklajevanje.	The Agency shall provide the secretariat of this coordination group.
Odbor za ocenjevanje tveganja na področju farmakovigilance iz točke (aa) člena 56(1) Uredbe (ES) št. 726/2004 s strokovnimi ocenami in priporočili pomaga skupini za usklajevanje pri izvajanju nalog farmakovigilance, vključno z odobritvijo sistemov obvladovanja tveganj in spremljanjem njihove učinkovitosti.	For the fulfilment of its pharmacovigilance tasks, including approving risk management systems and monitoring their effectiveness, the coordination group shall rely on the scientific assessment and the recommendations of the Pharmacovigilance Risk Assessment Committee provided for in Article 56(1)(aa) of Regulation (EC) No 726/2004.
2.	2.
Skupina za usklajevanje je sestavljena iz enega predstavnika vsake države članice, imenovanega za obdobje treh let, ki se lahko podaljša. Države članice lahko imenujejo namestnika za obdobje treh let, ki se lahko podaljša. Člane skupine za usklajevanje lahko spremljajo strokovnjaki.	The coordination group shall be composed of one representative per Member State appointed for a renewable period of 3 years. Member States may appoint an alternate for a renewable period of 3 years. Members of the coordination group may arrange to be accompanied by experts.
Člani skupine za usklajevanje in strokovnjaki se pri izvajanju svojih nalog opirajo na znanstvene in ureditvene vire, ki so na voljo pristojnim nacionalnim organom. Vsak pristojen nacionalni organ spremlja raven strokovnosti opravljenega vrednotenja ter olajša dejavnosti imenovanih članov skupine za usklajevanje in strokovnjakov.	Members of the coordination group and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to national competent authorities. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts.
Za skupino za usklajevanje se glede preglednosti in neodvisnosti njenih članov uporablja člen 63 Uredbe (ES) št. 726/2004.	Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination group as regards transparency and the independence of its members.
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3.	3.
Skupina za usklajevanje pripravi svoj poslovnik, ki začne veljati takoj po odobritvi s strani Komisije. Poslovnik se javno objavi.	The coordination group shall draw up its own Rules of Procedure, which shall enter into force after a favourable opinion has been given by the Commission. These Rules of Procedure shall be made public.
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4.	4.
Izvršni direktor Agencije ali njegov predstavnik in predstavniki Komisije imajo pravico biti navzoči pri vseh srečanjih skupine za usklajevanje.	The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination group.
5.	5.
Člani skupine za usklajevanje zagotavljajo ustrezno koordinacijo med nalogami navedene skupine in delom pristojnih nacionalnih organov, vključno s posvetovalnimi organi, ki jih dovoljenje za promet z zdravilom zadeva.	The members of the coordination group shall ensure that there is appropriate coordination between the tasks of that group and the work of national competent authorities, including the consultative bodies concerned with the marketing authorisation.
6.	6.
Razen če ni v tej direktivi določeno drugače, si države članice, zastopane v skupini za usklajevanje, kar najbolj prizadevajo, da s soglasjem dosežejo stališče o ukrepih, ki jih je treba sprejeti. Če takega soglasja ni mogoče doseči, prevlada stališče večine držav članic, zastopanih v skupini za usklajevanje.	Save where otherwise provided for in this Directive, the Member States represented within the coordination group shall use their best endeavours to reach a position by consensus on the action to be taken. If such a consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall prevail.
7.	7.
Od članov skupine za usklajevanje se tudi po prenehanju njihovih dolžnosti zahteva, da ne razkrijejo podatkov, ki jih zajema obveznost varovanja poslovne skrivnosti.	Members of the coordination group shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.
POGLAVJE 4	CHAPTER 4
Postopek z medsebojnim priznavanjem in decentraliziran postopek	Mutual recognition and decentralised procedure
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Člen 28	Article 28
1.	1.
Za pridobitev dovoljenja za promet z zdravilom v več kot eni državi članici, predlagatelj predloži vlogo na podlagi enakega dosjeja v teh državah članicah. Dosje zajema informacije in dokumente iz členov 8, 10, 10a, 10b, 10c in 11. Predloženi dokumenti vsebujejo seznam držav članic, ki jih vloga zadeva.	With a view to the granting of a marketing authorisation for a medicinal product in more than one Member State, an applicant shall submit an application based on an identical dossier in these Member States. The dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11. The documents submitted shall include a list of Member States concerned by the application.
Predlagatelj zaprosi eno od držav članic, da deluje kot „referenčna država članica“; in pripravi poročilo o oceni zdravila v skladu z odstavkom 2 ali 3.	The applicant shall request one Member State to act as ‘reference Member State’ and to prepare an assessment report on the medicinal product in accordance with paragraphs 2 or 3.
2.	2.
Kadar je v času vložitve vloge dovoljenje za promet z zdravilom že izdano, zadevne države članice priznajo dovoljenje za promet, ki ga je izdala referenčna država članica. V ta namen imetnik dovoljenja za promet z zdravilom prosi referenčno državo članico, da bodisi pripravi poročilo o oceni zdravila ali, če je to potrebno, z zadnjimi podatki dopolni obstoječe poročilo o oceni zdravila.Referenčna država članica pripravi ali ažurira poročilo o oceni zdravila v 90 dneh od prejetja popolne vloge. Poročilo o oceni zdravila se skupaj z odobrenim povzetkom glavnih značilnosti zdravila, ovojnino in navodilom za uporabo pošlje zadevnim državam članicam in predlagatelju.	Where the medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned Member States and to the applicant.
3.	3.
Kadar zdravilo v času vloge še ni pridobilo dovoljenja za promet, predlagatelj referenčno državo članico prosi, da pripravi osnutek poročila o oceni zdravila, osnutek povzetka glavnih značilnosti zdravila ter osnutek ovojnine in navodila za uporabo. Referenčna država članica pripravi osnutke teh dokumentov v 120 dneh od prejema popolne vloge in jih pošlje zadevnim državam članicam in predlagatelju.	In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The reference Member State shall prepare these draft documents within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant.
4.	4.
V 90 dneh od prejema dokumentov iz odstavkov 2 in 3, zadevne države članice odobrijo poročilo o oceni zdravila, povzetek glavnih značilnosti zdravila ter ovojnino in navodilo za uporabo, ter o tem obvestijo referenčno državo članico. Referenčna država članica zabeleži strinjanje vseh strank, zaključi postopek in o tem obvesti predlagatelja.	Within 90 days of receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly.
5.	5.
Vsaka država članica, v kateri se vloži vloga v skladu z odstavkom 1, v 30 dneh po potrditvi strinjanja sprejme odločitev v skladu z odobrenim poročilom o oceni zdravila, povzetkom glavnih značilnosti zdravila ter ovojnino in navodilom za uporabo.	Each Member State in which an application has been submitted in accordance with paragraph 1 shall adopt a decision in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved, within 30 days after acknowledgement of the agreement.
Člen 29	Article 29
1.	1.
Če država članica v obdobju iz člena 28(4) ne more odobriti poročila o oceni zdravila, povzetka glavnih značilnosti zdravila, ovojnine in navodila za uporabo zaradi možnega resnega tveganja za javno zdravje, navede podrobne razloge za svoje stališče in o tem obvesti referenčno državo članico, druge zadevne države članice in predlagatelja. O točkah nestrinjanja je nemudoma obveščena tudi skupina za usklajevanje.	If, within the period laid down in Article 28(4), a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group.
2.	2.
Smernice, ki naj jih sprejme Komisija, opredeljujejo možna resna tveganja za javno zdravje.	Guidelines to be adopted by the Commission shall define a potential serious risk to public health.
3.	3.
V skupini za usklajevanje se vse države članice iz odstavka 1 kar najbolj potrudijo, da dosežejo dogovor o potrebnem ukrepanju. Predlagatelju dajo možnost, da svoje stališče izrazi ustno ali pisno. Če države članice v 60 dneh od obvestila o točkah nestrinjanja dosežejo dogovor, referenčna država članica zabeleži dogovor, zaključi postopek in o tem obvesti predlagatelja. Uporabi se člen 28(5).	Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the points of disagreement, the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 28(5) shall apply.
4.	4.
Če države članice ne dosežejo dogovora v 60-dnevnem roku iz odstavka 3, o zadevi nemudoma obvestijo Agencijo zaradi uporabe postopka iz členov 32, 33 in 34. Agenciji je treba predložiti podrobno poročilo glede zadev, o katerih države članice niso mogle doseči dogovora, ter razloge za njihovo nestrinjanje. Kopija se pošlje predlagatelju.	If the Member States fail to reach an agreement within the 60-day period laid down in paragraph 3, the Agency shall be immediately informed, with a view to the application of the procedure under Articles 32, 33 and 34. The Agency shall be provided with a detailed statement of the matters on which the Member States have been unable to reach agreement and the reasons for their disagreement. A copy shall be forwarded to the applicant.
5.	5.
Takoj ko predlagatelj prejme obvestilo, da je bila zadeva predana Agenciji, ji nemudoma pošlje kopijo informacij in dokumentov iz prvega pododstavka člena 28(1).	As soon as the applicant is informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 28(1).
6.	6.
V okoliščinah iz odstavka 4, države članice, ki so odobrile poročilo o oceni zdravila, povzetek glavnih značilnosti zdravila ter ovojnino in navodilo za uporabo referenčne države članice, lahko na zahtevo predlagatelja izdajo dovoljenje za promet z zdravilom, ne da bi počakale na rezultat postopka iz člena 32. V tem primeru izdano dovoljenje ne vpliva na rezultat tega postopka.	In the circumstances referred to in paragraph 4, Member States that have approved the assessment report, the draft summary of product characteristics and the labelling and package leaflet of the reference Member State may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 32. In that event, the authorisation granted shall be without prejudice to the outcome of that procedure.
Člen 30	Article 30
1.	1.
Če je bilo v skladu s členi 8, 10, 10a, 10b, 10c in 11 predloženih več vlog za pridobitev dovoljenja za promet z določenim zdravilom in so države članice sprejele različne odločitve v zvezi s pridobitvijo dovoljenja za promet z določenim zdravilom, preklicem ali umikom, lahko država članica, Komisija ali pa predlagatelj ali imetnik dovoljenja za promet z zdravilom zadevo predloži Odboru za zdravila za uporabo v humani medicini, v nadaljnjem besedilu „odbor“, za uporabo postopka iz členov 32, 33 in 34.	If two or more applications submitted in accordance with Articles 8, 10, 10a, 10b, 10c and 11 have been made for marketing authorisation for a particular medicinal product, and if Member States have adopted divergent decisions concerning the authorisation of the medicinal product or its suspension or revocation, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use, hereinafter referred to as ‘the Committee’, for the application of the procedure laid down in Articles 32, 33 and 34.
2.	2.
Zaradi spodbujanja usklajenosti dovoljenj za promet za zdravila, izdanih v Skupnosti, države članice vsako leto pošljejo skupini za usklajevanje seznam zdravil, za katere je treba pripraviti usklajen povzetek glavnih značilnosti zdravila.	In order to promote harmonisation of authorisations for medicinal products authorised in the Community, Member States shall, each year, forward to the coordination group a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.
Skupina za usklajevanje na podlagi predlogov držav članic pripravi seznam in ga pošlje Komisiji.	The coordination group shall lay down a list taking into account the proposals from all Member States and shall forward this list to the Commission.
Komisija ali država članica lahko v soglasju z Agencijo in ob upoštevanju stališč zainteresiranih strank ta zdravila predloži odboru v skladu z odstavkom 1.	The Commission or a Member State, in agreement with the Agency and taking into account the views of interested parties, may refer these products to the Committee in accordance with paragraph 1.
Člen 31	Article 31
1.	1.
►M10 Države članice, Komisija, predlagatelj ali imetnik dovoljenja za promet z zdravilom v posebnih primerih, kadar gre za interese Unije, zadevo predloži odboru za uporabo postopka iz členov 32, 33 in 34 pred sprejetjem odločitve glede vloge za izdajo dovoljenja za promet z zdravilom, glede začasnega preklica ali razveljavitve dovoljenja za promet z zdravilom ali kakršne koli spremembe dovoljenja za promet z zdravilom, ki je potrebna. ◄	►M10 The Member States, the Commission, the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Union are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary. ◄
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Kadar je napotitev rezultat ocene podatkov v zvezi s farmakovigilanco zdravila, ki je pridobilo dovoljenje za promet, se zadeva posreduje Odboru za ocenjevanje tveganja na področju farmakovigilance in se lahko uporabi člen 107j(2). Odbor za ocenjevanje tveganja na področju farmakovigilance izda priporočilo v skladu s postopkom iz člena 32. Končno priporočilo se posreduje Odboru za zdravila za uporabo v humani medicini ali skupini za usklajevanje, uporabi pa se postopek iz člena 107k.	Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) may be applied. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the coordination group, as appropriate, and the procedure laid down in Article 107k shall apply.
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Kadar pa je izpolnjeno eno od meril iz člena 107i(1), se uporabi postopek iz členov 107i do 107k.	However, where one of the criteria listed in Article 107i(1) is met, the procedure laid down in Articles 107i to 107k shall apply.
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Zadevna država članica ali Komisija jasno opredeli vprašanje, predloženo odboru v obravnavo, in obvesti imetnika dovoljenja za promet z zdravilom.	The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.
Države članice in imetnik dovoljenja za promet z zdravilom odboru pošljejo vse razpoložljive informacije v zvezi z omenjeno zadevo.	The Member States and the applicant or the marketing authorisation holder shall supply the Committee with all available information relating to the matter in question.
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2.	2.
Kadar se odboru v obravnavo predloži niz zdravil ali terapevtska skupina, lahko Agencija omeji postopek na nekatere posebne dele dovoljenja za promet.	Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation.
V tem primeru se člen 35 za ta zdravila uporabi samo, če jih zajemajo postopki izdaje dovoljenja iz tega poglavja.	In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter.
Kadar področje uporabe postopka, začetega na podlagi tega člena, zadeva niz zdravil ali terapevtsko skupino, so v postopek vključena tudi zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, ki sodijo v navedeni niz ali skupino.	Where the scope of the procedure initiated under this Article concerns a range of medicinal products or a therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure.
3.	3.
Brez poseganja v odstavek 1 lahko država članica, če je v kateri koli fazi postopka potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno odvzame dovoljenje za promet z zdravilom in prepove uporabo zadevnega zdravila na svojem ozemlju do sprejetja dokončne odločitve. O razlogih za tako ukrepanje obvesti Komisijo, Agencijo in druge države članice najpozneje naslednji delovni dan.	Without prejudice to paragraph 1, a Member State may, where urgent action is necessary to protect public health at any stage of the procedure, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted. It shall inform the Commission, the Agency and the other Member States, no later than the following working day, of the reasons for its action.
4.	4.
Kadar področje uporabe postopka, začetega na podlagi tega člena, kakor je določeno v skladu z odstavkom 2, vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, lahko Komisija, če je v kateri koli fazi postopka potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno odvzame dovoljenje za promet in prepove uporabo zadevnega zdravila do sprejetja dokončne odločitve. O razlogih za tako ukrepanje Komisija obvesti Agencijo in države članice najpozneje naslednji delovni dan.	Where the scope of the procedure initiated under this Article, as determined in accordance with paragraph 2, includes medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Commission may, where urgent action is necessary to protect public health, at any stage of the procedure, suspend the marketing authorisations and prohibit the use of the medicinal products concerned until a definitive decision is adopted. The Commission shall inform the Agency and the Member States no later than the following working day of the reasons for its action.
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Člen 32	Article 32
1.	1.
Pri sklicu na postopek iz tega člena, odbor obravnava zadevo in izda obrazloženo mnenje v 60 dneh od dneva, ko mu je bila zadeva predložena.	When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it.
Pri zadevah, predloženih odboru v skladu s členi 30 in 31, odbor lahko to obdobje podaljša za največ 90 dni, ob upoštevanju stališč zadevnih predlagateljev ali imetnikov dovoljenja za promet z zdravili.	However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the applicants or the marketing authorisation holders concerned.
V nujnem primeru se odbor na predlog svojega predsednika lahko odloči tudi za krajši rok.	In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline.
2.	2.
Za obravnavo zadeve lahko odbor enega svojih članov imenuje za poročevalca. Odbor lahko imenuje tudi posamezne strokovnjake za svetovanje o posebnih vprašanjih. Pri imenovanju strokovnjakov Odbor opredeli njihove naloge in določi rok za dokončanje teh nalog.	In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks.
3.	3.
Preden odbor da svoje mnenje, da imetniku dovoljenja za promet z zdravilom možnost, da da pisno ali ustno obrazložitev v roku, ki ga določi odbor.	Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it shall specify.
Mnenje odbora mora spremljati osnutek povzetka glavnih značilnosti zdravila ter osnutek besedila ovojnine in navodila za uporabo.	The opinion of the Committee shall be accompanied by a draft summary of product characteristics for the product and a draft text of the labelling and package leaflet.
Če je primerno, lahko odbor povabi katero koli drugo osebo, da zagotovi informacije v zvezi z zadevo, ki jo odbor obravnava.	If necessary, the Committee may call upon any other person to provide information relating to the matter before it.
Odbor lahko začasno prekine časovni rok iz odstavka 1, da imetniku dovoljenja za promet z zdravilom omogoči, da pripravi obrazložitve.	The Committee may suspend the time-limits referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder to prepare explanations.
4.	4.
Agencija takoj obvesti imetnika dovoljenja za promet z zdravilom, kadar odbor meni:	The Agency shall forthwith inform the applicant or the marketing authorisation holder where the opinion of the Committee is that:
(a)	(a)
da vloga ne izpolnjuje meril za pridobitev dovoljenja za promet z zdravilom; ali	the application does not satisfy the criteria for authorisation; or
(b)	(b)
da je treba dopolniti povzetek glavnih značilnosti zdravila, ki ga predlaga predlagatelj ali imetnik dovoljenja za promet z zdravilom v skladu s členom 11; ali	the summary of the product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 11 should be amended; or
(c)	(c)
da je izdajo dovoljenja treba odobriti pod določenimi pogoji, glede na pogoje, ki so bistveni za varno in učinkovito uporabo zdravila, vključno s farmakovigilanco; ali	the authorisation should be granted subject to certain conditions, in view of conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance; or
(d)	(d)
da je treba dovoljenje za promet z zdravilom preklicati, spremeniti ali umakniti.	a marketing authorisation should be suspended, varied or revoked.
V 15 dneh od prejetja mnenja lahko predlagatelj ali imetnik dovoljenja za promet z zdravilom v pisni obliki uradno obvesti Agencijo, da bo zahteval ponoven pregled mnenja. V tem primeru v 60 dneh od prejetja mnenja Agenciji pošlje podrobne utemeljitve za zahtevo.	Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.
V 60 dneh po prejetju utemeljitev za zahtevo odbor ponovno preuči svoje mnenje v skladu s četrtim pododstavkom člena 62(1) Uredbe (ES) št. 726/2004. Razloge za sprejeto odločitev priloži poročilu o oceni zdravila iz odstavka 5 tega člena.	Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004. The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article.
5.	5.
V 15 dneh od sprejetja mnenja, Agencija pošlje končno mnenje odbora državam članicam, Komisiji in predlagatelju ali imetniku dovoljenja za promet z zdravilom, skupaj s poročilom o oceni zdravila in navedbo razlogov za svoje sklepe.	Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to the Member States, to the Commission and to the applicant or the marketing authorisation holder, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions.
Če gre za mnenje, ki je v prid izdaji dovoljenja za promet ali ohranitvi dovoljenja za dajanje zadevnega zdravila na trg, se k mnenju priložijo naslednji dokumenti:	In the event of an opinion in favour of granting or maintaining an authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion:
(a)	(a)
osnutek povzetka glavnih značilnosti zdravila, kot je določeno v členu 11;	a draft summary of the product characteristics, as referred to in Article 11;
(b)	(b)
pogoji, ki vplivajo na izdajo dovoljenja v smislu odstavka 4(c);	any conditions affecting the authorisation within the meaning of paragraph 4(c);
(c)	(c)
podrobni podatki o vseh priporočenih pogojih ali omejitvah v zvezi z varno in učinkovito uporabo zdravila;	details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product;
(d)	(d)
predlog besedila za ovojnino in navodilo za uporabo.	the proposed text of the labelling and leaflet.
▼B	▼B
Člen 33	Article 33
V ►M4 15-ih dneh ◄ po prejetju mnenja Komisija pripravi osnutek odločbe, ki jo je treba ob upoštevanju zakonodaje Skupnosti sprejeti glede vloge.	Within ►M4 15 days ◄ of the receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.
Če osnutek odločbe predvideva izdajo dovoljenja za promet z zdravilom, je treba priložiti dokumente ►M4 iz drugega pododstavka člena 32(5) ◄ .	In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in ►M4 Article 32(5), second subparagraph ◄ shall be annexed.
Kadar, izjemoma, osnutek odločbe ni v skladu z mnenjem Agencije, Komisija priloži tudi podrobno obrazložitev razlogov za razhajanja.	Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.
Osnutek odločbe pošlje državam članicam in vlagatelju ►M4 ali imetniku dovoljenja za promet z zdravilom. ◄	The draft decision shall be forwarded to the Member States and the applicant ►M4 or the marketing authorisation holder ◄ .
▼M4	▼M4
Člen 34	Article 34
1.	1.
Komisija sprejme končno odločitev v skladu z in v roku 15 dni po zaključku postopka iz člena 121(3).	The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 121(3).
2.	2.
Poslovnik Stalnega odbora, ustanovljenega s členom 121(1), se prilagodi zaradi upoštevanja nalog, za katere je zadolžen v skladu s tem poglavjem.	The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it under this Chapter.
Prilagoditve vključujejo naslednje določbe:	Those adjustments shall entail the following provisions:
(a)	(a)
razen v primeru, navedenem v tretjem odstavku člena 33, se mnenje Stalnega odbora da v pisni obliki;	except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be given in writing;
(b)	(b)
države članice imajo na voljo 22 dni, da Komisiji predložijo pisne pripombe na osnutek odločbe. Če je sprejetje odločbe nujno, lahko predsednik glede na stopnjo nujnosti zadeve določi krajši časovni rok. Ta časovni rok, razen v izjemnih okoliščinah, ne sme biti krajši od 5 dni;	Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days;
(c)	(c)
vsaka država članica sme v pisni obliki zahtevati, da o osnutku odločbe razpravlja tudi Stalni odbor na svojem plenarnem zasedanju.	Member States shall have the option of submitting a written request that the draft Decision be discussed in a plenary meeting of the Standing Committee.
Kadar po mnenju Komisije pisne pripombe države članice odpirajo pomembna nova vprašanja znanstvene ali tehnične narave, ki niso bila navedena v mnenju Agencije, predsednik začasno ustavi postopek in vlogo vrne Agenciji v nadaljnjo obravnavo.	Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
Določbe, potrebne za izvajanje tega odstavka, sprejme Komisija v skladu s postopkom iz člena 121(2).	The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2).
3.	3.
Odločba, navedena v odstavku 1, se naslovi na vse države članice in pošlje v vednost imetniku dovoljenja za promet z zdravilom ali predlagatelju. Zadevne države članice in referenčna država članica odobrijo ali zavrnejo izdajo dovoljenja za promet z zdravilom, ali spremenijo pogoje izdaje dovoljenja za promet z zdravilom, kot je potrebno za uskladitev z odločbo, v 30 dneh od uradnega obvestila o njej in se nanjo sklicujejo. O tem ustrezno obvestijo Komisijo in Agencijo.	The decision as referred to in paragraph 1 shall be addressed to all Member States and reported for information to the marketing authorisation holder or applicant. The concerned Member States and the reference Member State shall either grant or revoke the marketing authorisation, or vary its terms as necessary to comply with the decision within 30 days following its notification, and they shall refer to it. They shall inform the Commission and the Agency accordingly.
▼M12	▼M12
Kadar področje uporabe postopka, začetega na podlagi člena 31, vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004 v skladu s tretjim pododstavkom člena 31(2) te direktive, Komisija po potrebi sprejme sklepe za spremembo, začasni odvzem ali ukinitev zadevnih dovoljenj za promet ali za zavrnitev podaljšanja zadevnih dovoljenj za promet.	Where the scope of the procedure initiated under Article 31 includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall, where necessary, adopt decisions to vary, suspend or revoke the marketing authorisations or to refuse the renewal of the marketing authorisations concerned.
▼B	▼B
Člen 35	Article 35
1.	1.
Vsaka vloga imetnika dovoljenja za promet z zdravilom za spremembo dovoljenja za promet, ki je bilo odobreno v skladu z določbami tega poglavja, se predloži vsem državam članicam, ki so predhodno izdale dovoljenje za promet z zadevnim zdravilom.	Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned.
▼M8 —————	▼M8 —————
▼M4 —————	▼M4 —————
▼M8 —————	▼M8 —————
▼B	▼B
2.	2.
V primeru arbitraže, predložene Komisiji, se smiselno uporabi postopek iz členov 32, 33 in 34 tudi za spremembe dovoljenj za promet z zdravili.	In case of arbitration submitted to the Commission, the procedure laid down in Articles 32, 33 and 34 shall apply by analogy to variations made to marketing authorizations.
▼M10 —————	▼M10 —————
▼B	▼B
Člen 37	Article 37
►M12 Člen 35 se smiselno uporablja ◄ za zdravila, za katere so države članice izdale dovoljenja na podlagi mnenja Odbora, ki ga je dal v skladu s členom 4 Direktive 87/22/EGS pred 1. januarjem 1995.	►M12 Article 35 shall apply ◄ by analogy to medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995.
Člen 38	Article 38
1.	1.
Agencija objavi letno poročilo o izvajanju postopkov iz tega poglavja ter poročilo pošlje Evropskemu parlamentu in Svetu v informacijo.	The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward that report to the European Parliament and the Council for information.
▼M4	▼M4
2.	2.
Najmanj vsakih deset let Komisija objavi poročilo o izkušnjah, pridobljenih na podlagi postopkov iz tega poglavja in predlaga morebitne spremembe, potrebne za izboljšanje teh postopkov. Komisija to poročilo predloži Evropskemu parlamentu in Svetu.	At least every ten years the Commission shall publish a report on the experience acquired on the basis of the procedures described in this Chapter and shall propose any amendments which may be necessary to improve those procedures. The Commission shall submit this report to the European Parliament and to the Council.
Člen 39	Article 39
Člen 29(4), (5) in (6) ter členi 30 do 34 se ne uporabljajo za homeopatska zdravila iz člena 14.	Article 29(4), (5) and (6) and Articles 30 to 34 shall not apply to the homeopathic medicinal products referred to in Article 14.
Členi 28 do 34 se ne uporabljajo za homeopatska zdravila iz člena 16(2).	Articles 28 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2).
▼B	▼B
NASLOV IV	TITLE IV
PROIZVODNJA IN UVOZ	MANUFACTURE AND IMPORTATION
Člen 40	Article 40
1.	1.
Države članice sprejmejo vse potrebne ukrepe, da na svojem ozemlju zagotovijo proizvodnjo zdravil na podlagi izdanega dovoljenja. Dovoljenje za proizvodnjo zdravil se zahteva tudi, če so proizvedena zdravila namenjena za izvoz.	Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorization. This manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export.
▼M16	▼M16
1a.	1a.
Z odstopanjem od odstavka 1 tega člena pristojni organi Združenega kraljestva v zvezi s Severno Irsko in do 31. decembra 2024 pristojni organi Cipra, Irske in Malte dovolijo uvoz zdravil iz delov Združenega kraljestva razen Severne Irske s strani imetnikov dovoljenja za promet na debelo iz člena 77(1), ki nimajo ustreznega dovoljenja za proizvodnjo, če so izpolnjeni vsi naslednji pogoji:	By way of derogation from paragraph 1 of this Article, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta shall allow medicinal products to be imported from parts of the United Kingdom other than Northern Ireland by holders of a wholesale distribution authorisation as referred to in Article 77(1) that are not in possession of a relevant manufacturing authorisation provided that all of the following conditions are fulfilled:
(a)	(a)
za zdravila so bila opravljena preskušanja z namenom kontrole kakovosti v Uniji, kot je določeno v členu 51(3), ali v delih Združenega kraljestva razen Severne Irske v skladu s členom 20, prvi odstavek, točka (b);	the medicinal products have undergone quality control testing either in the Union, as provided for in Article 51(3), or in parts of the United Kingdom other than Northern Ireland in compliance with Article 20, first paragraph, point (b);
(b)	(b)
zdravila so bila predmet sprostitve serije, ki jo je opravila usposobljena oseba v Uniji v skladu s členom 51(1) ali, za zdravila, ki so jih odobrili pristojni organi Cipra, Irske, Malte in Združenega kraljestva v zvezi s Severno Irsko, v delih Združenega kraljestva razen Severne Irske z uporabo standardov kakovosti, enakovrednih tistim iz člena 51(1);	the medicinal products have been subject to batch release by a qualified person in the Union in accordance with Article 51(1) or, for medicinal products authorised by the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland, in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in Article 51(1);
(c)	(c)
dovoljenje za promet z zadevnim zdravilom je v skladu s pravom Unije izdal pristojni organ države članice ali Komisija ali, kar zadeva zdravila, dana v promet na Severnem Irskem, pristojni organ Združenega kraljestva v zvezi s Severno Irsko;	the marketing authorisation for the medicinal product concerned has been granted in accordance with Union law, by the competent authority of a Member State or by the Commission or, as regards medicinal products placed on the market in Northern Ireland, by the competent authority of the United Kingdom in respect of Northern Ireland;
(d)	(d)
zdravila so na voljo samo bolnikom ali končnim potrošnikom v državi članici, v katero se zdravila uvažajo, oziroma če se uvažajo na Severno Irsko, so na voljo samo bolnikom ali končnim potrošnikom na Severnem Irskem;	medicinal products are only made available to patients or end-consumers in the Member State into which the medicinal products are imported, or, if imported into Northern Ireland, are only made available to patients or end-consumers in Northern Ireland;
(e)	(e)
zdravila imajo zaščitne elemente iz člena 54, točka (o).	the medicinal products bear the safety features referred to in Article 54, point (o).
Člen 80, prvi pododstavek, točka (b), se ne uporablja za uvoze, ki izpolnjujejo pogoje iz prvega pododstavka tega odstavka.	Article 80, first subparagraph, point (b), shall not apply to imports that fulfil the conditions laid down in the first subparagraph of this paragraph.
▼B	▼B
2.	2.
Dovoljenje iz odstavka 1 se zahteva za celoten in del postopka proizvodnje, ter za različne postopke delitve zdravila na manjše enote, pakiranja ali opremljanja zdravil.	The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.
To dovoljenje se ne zahteva za pripravo, delitev zdravila na manjše enote, spremembe v pakiranju ali opremljanju zdravil, kadar se ti postopki izvajajo izključno za promet na drobno prek farmacevtov v lekarnah ali prek oseb, ki so v državah članicah zakonito pooblaščene za izvajanje tovrstnih postopkov.	However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.
3.	3.
Dovoljenje iz odstavka 1 se zahteva tudi za uvoz zdravil iz tretjih držav v državo članico; ta naslov in člen 118 se uporabljata hkrati za uvoz in za proizvodnjo.	Authorization referred to in paragraph 1 shall also be required for imports coming from third countries into a Member State; this Title and Article 118 shall have corresponding application to such imports as they have to manufacture.
▼M16	▼M16
3a.	3a.
Za serije zdravil, ki se iz države članice izvažajo v dele Združenega kraljestva razen Severne Irske in se nato uvažajo na Severno Irsko ali do 31. decembra 2024 na Ciper, Irsko ali Malto, kontrole ob uvozu iz člena 51(1), prvi in drugi pododstavek, niso potrebne, če so bile za te serije opravljene takšne kontrole v državi članici pred izvozom v dele Združenega kraljestva razen Severne Irske in če jih spremljajo poročila o kontroli iz člena 51(1), tretji pododstavek.	For batches of medicinal products which are exported to parts of the United Kingdom other than Northern Ireland from a Member State and subsequently imported into Northern Ireland or, until 31 December 2024, into Cyprus, Ireland or Malta, the controls upon importation referred to Article 51(1), first and second subparagraphs, shall not be required, provided that those batches have undergone such controls in a Member State prior to being exported to parts of the United Kingdom other than Northern Ireland and that they are accompanied by the control reports referred to in Article 51(1), third subparagraph.
▼M11	▼M11
4.	4.
Države članice vnesejo informacije v zvezi z dovoljenjem iz odstavka 1 tega člena v podatkovno bazo Unije iz člena 111(6).	Member States shall enter the information relating to the authorisation referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6).
▼B	▼B
Člen 41	Article 41
Za pridobitev dovoljenja za proizvodnjo zdravila mora vlagatelj izpolnjevati najmanj naslednje zahteve:	In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:
(a)	(a)
navede zdravila in farmacevtske oblike, ki jih bo proizvajal ali uvažal, ter mesto proizvodnje in/ali kontrole;	specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;
(b)	(b)
za proizvodnjo ali uvoz zdravil mora imeti na voljo primerne in ustrezne prostore, tehnično opremo ter potrebno opremo za kontrolo, ki so v skladu s pravnimi zahtevami, ki jih je zadevna država članica določila za proizvodnjo in kontrolo ter shranjevanje zdravil, skladno s členom 20;	have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 20;
(c)	(c)
imeti mora na voljo najmanj eno odgovorno osebo v smislu člena 48.	have at his disposal the services of at least one qualified person within the meaning of Article 48.
Vlagatelj v svoji vlogi predloži podrobne podatke o razpolaganju z zgoraj naštetim.	The applicant shall provide particulars in support of the above in his application.
Člen 42	Article 42
1.	1.
Pristojni organ države članice izda dovoljenje za proizvodnjo zdravil potem, ko njegovi zastopniki s pregledom preverijo točnost podrobnih podatkov, predloženih v skladu s členom 41.	The competent authority of the Member State shall issue the manufacturing authorization only after having made sure of the accuracy of the particulars supplied pursuant to Article 41, by means of an inquiry carried out by its agents.
2.	2.
Da se zagotovi izpolnjevanje zahtev iz člena 41, se dovoljenje lahko izda pogojno glede na izpolnjevanje nekaterih obveznosti, ki se vlagatelju naložijo ob izdaji dovoljenja ali pozneje.	In order to ensure that the requirements referred to in Article 41 are complied with, authorization may be made conditional on the carrying out of certain obligations imposed either when authorization is granted or at a later date.
3.	3.
Dovoljenje velja samo za prostore, navedene v vlogi, ter za zdravila in farmacevtske oblike, navedene v isti vlogi.	The authorization shall apply only to the premises specified in the application and to the medicinal products and pharmaceutical forms specified in that same application.
Člen 43	Article 43
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da čas, potreben za postopek izdaje dovoljenja za proizvodnjo ne presega 90 dni od dneva, ko pristojni organ prejme vlogo.	The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the manufacturing authorization does not exceed 90 days from the day on which the competent authority receives the application.
Člen 44	Article 44
Če imetnik dovoljenja za proizvodnjo zahteva spremembo katerega koli podrobnega podatka iz točk (a) in (b) prvega odstavka člena 41, čas postopka v zvezi s to zahtevo ne presega 30 dni. V izjemnih primerih se sme rok podaljšati na 90 dni.	If the holder of the manufacturing authorization requests a change in any of the particulars referred to in points (a) and (b) of the first paragraph of Article 41, the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases this period of time may be extended to 90 days.
Člen 45	Article 45
Pristojni organ države članice od vlagatelja lahko zahteva nadaljnje informacije o predloženih podrobnih podatkih na podlagi člena 41 in v zvezi z odgovorno osebo, omenjeno v členu 48; kadar zadevni pristojni organ uporabi to pravico, časovni roki iz členov 43 in 44 prenehajo teči do predložitve zahtevanih dodatnih podatkov.	The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 41 and concerning the qualified person referred to in Article 48; where the competent authority concerned exercises this right, application of the time-limits referred to in Article 43 and 44 shall be suspended until the additional data required have been supplied.
Člen 46	Article 46
Imetnik dovoljenja za proizvodnjo mora obvezno najmanj:	The holder of a manufacturing authorization shall at least be obliged:
(a)	(a)
imeti na voljo storitve osebja, ki izpolnjuje pravne zahteve, ki obstajajo v državi članici, glede proizvodnje in kontrole;	to have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;
(b)	(b)
imeti na voljo zdravila, za katera je bilo izdano dovoljenje za promet samo v skladu z zakonodajo zadevnih držav članic;	to dispose of the authorized medicinal products only in accordance with the legislation of the Member States concerned;
(c)	(c)
predhodno obvestiti pristojni organ o vseh spremembah, ki jih želi izvesti v zvezi s katerimi koli podrobnimi podatki na podlagi člena 41; pristojni organ mora biti v vsakem primeru takoj obveščen, če se odgovorna oseba iz člena 48 nepričakovano zamenja;	to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant to Article 41; the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 48 is replaced unexpectedly;
(d)	(d)
dovoliti zastopnikom pristojnega organa zadevne države članice dostop do prostorov ob vsakem času;	to allow the agents of the competent authority of the Member State concerned access to his premises at any time;
(e)	(e)
omogočiti odgovorni osebi iz člena 48, da opravlja svoje dolžnosti, na primer s tem, da so ji na voljo vsa potrebna sredstva;	to enable the qualified person referred to in Article 48 to carry out his duties, for example by placing at his disposal all the necessary facilities;
▼M11	▼M11
(f)	(f)
upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabljati samo zdravilne učinkovine, ki so bile proizvedene v skladu s smernicami dobre proizvodne prakse za zdravilne učinkovine in je njihova distribucija potekala v skladu z dobro distribucijsko prakso za zdravilne učinkovine. V ta namen imetnik dovoljenja za proizvodnjo preveri skladnost proizvajalca in distributerjev zdravilnih učinkovin z dobro proizvodno prakso in dobrimi distribucijskimi praksami, in sicer z opravljanjem revizij na kraju proizvodnje in distribucije proizvajalcev in distributerjev zdravilnih učinkovin. Imetnik dovoljenja za proizvodnjo preveri takšno skladnost sam ali pa, ne da bi to posegalo v njegovo odgovornost iz te direktive, preko subjekta, ki preko pogodbe deluje v njegovem imenu.	to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use only active substances, which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances. To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract.
Imetnik dovoljenja za proizvodnjo zagotovi, da so pomožne snovi primerne za uporabo v zdravilih, in sicer z določitvijo, kaj je ustrezna dobra proizvodna praksa. To se določi na podlagi formalizirane ocene tveganja v skladu z veljavnimi smernicami iz petega odstavka člena 47. Ta ocena tveganja upošteva zahteve drugih ustreznih sistemov kakovosti kakor tudi vir in predvideno uporabo pomožnih snovi ter predhodne primere napak v kakovosti. Imetnik dovoljenja za proizvodnjo zagotovi, da se uporablja tako določena dobra proizvodna praksa. Imetnik dovoljenja za proizvodnjo dokumentira ukrepe, povzete v skladu s tem odstavkom;	The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47. Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied. The holder of the manufacturing authorisation shall document the measures taken under this paragraph;
(g)	(g)
nemudoma obvestiti pristojni organ in imetnika dovoljenja za promet z zdravilom, če pridobi informacije, da so zdravila, ki sodijo v okvir njegovega dovoljenja za proizvodnjo, ponarejena ali zanje obstaja sum, da so ponarejena, ne glede na to, ali je distribucija teh zdravil potekala po zakoniti dobavni verigi ali na nezakonit način, vključno s tistimi, ki se nezakonito prodajajo s sredstvi storitev informacijske družbe;	to inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;
(h)	(h)
preveriti, da so proizvajalci, uvozniki ali distributerji, od katerih so pridobili zdravilne učinkovine, registrirani pri pristojnem organu države članice, v kateri imajo sedež;	to verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established;
(i)	(i)
preveriti avtentičnost in kakovost zdravilnih učinkovin in pomožnih snovi.	to verify the authenticity and quality of the active substances and the excipients.
▼M4	▼M4
Člen 46a	Article 46a
1.	1.
Za namene te direktive, izdelava zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, zajema tako celotno kot delno izdelavo ali uvoz zdravilne učinkovine, ki se uporabi kot vhodna snov, kot je določeno v točki 3.2.1.1 (b) dela I Priloge I, ter različne postopke delitve na manjše enote, pakiranja ali opremljanja pred njihovo vključitvijo v zdravilo, vključno s ponovnim pakiranjem ali ponovnim označevanjem, kot ga opravlja distributer vhodnih snovi.	For the purposes of this Directive, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.
▼M15	▼M15
2.	2.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za spremembo odstavka 1, da se upoštevata znanstveni in tehnični napredek.	The Commission is empowered to adopt delegated acts in accordance with Article 121a to amend paragraph 1 to take account of scientific and technical progress.
▼M11	▼M11
Člen 46b	Article 46b
1.	1.
Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da so proizvodnja, uvoz in distribucija zdravilnih učinkovin na njihovem ozemlju, vključno z zdravilnimi učinkovinami, namenjenimi izvozu, skladni z dobro proizvodno prakso in dobrimi distribucijskimi praksami za zdravilne učinkovine.	Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of active substances, including active substances that are intended for export, comply with good manufacturing practice and good distribution practices for active substances.
2.	2.
Zdravilne učinkovine se uvozijo samo, če so izpolnjeni naslednji pogoji:	Active substances shall only be imported if the following conditions are fulfilled:
(a)	(a)
zdravilne učinkovine so bile proizvedene v skladu s standardi dobre proizvodne prakse, ki so najmanj enakovredni tistim, ki jih določa Unija v skladu s tretjim odstavkom člena 47, ter	the active substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; and
(b)	(b)
zdravilnim učinkovinam je priloženo pisno potrdilo pristojnega organa iz tretje države izvoza, da:	the active substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following:
(i)	(i)
so standardi dobre proizvodne prakse, ki se uporabljajo za obrat, v katerem se izdeluje izvožena zdravilna učinkovina, vsaj enakovredni standardom, ki jih določa Unija v skladu s tretjim odstavkom člena 47;	the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47;
(ii)	(ii)
se na zadevnem proizvodnem obratu izvaja reden, strog in pregleden nadzor ter se v njem učinkovito izvršuje dobra proizvodnja praksa, vključno z večkratnimi in nenapovedanimi inšpekcijskimi pregledi, kar zagotavlja varovanje javnega zdravja na ravni, vsaj enakovredni tisti v Uniji, in	the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and
(iii)	(iii)
v primeru ugotovitve neskladnosti, tretja država izvoznica informacije o tej ugotovitvi nemudoma pošlje Uniji.	in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.
Ta pisna izjava ne posega v obveznosti iz člena 8 ter točke (f) člena 46.	This written confirmation shall be without prejudice to the obligations set out in Article 8 and in point (f) of Article 46.
3.	3.
Zahteva, določena v točki (b) odstavka 2 tega člena, se ne uporablja, če je država izvoza uvrščena na seznam iz člena 111b.	The requirement set out in point (b) of paragraph 2 of this Article shall not apply if the exporting country is included in the list referred to in Article 111b.
4.	4.
Izjemoma in kjer je to potrebno za zagotovitev razpoložljivosti zdravil, kadar je obrat, v katerem se proizvaja zdravilna učinkovina za izvoz, pregledala država članica in ugotovila, da ravna v skladu z načeli in smernicami dobre proizvodne prakse, določene v skladu s tretjim odstavkom člena 47, lahko katera koli država članica odstopi od zahteve iz točke (b) odstavka 2 tega člena za obdobje, ki ne presega veljavnosti potrdila o dobri proizvodni praksi. Države članice, ki uporabijo to možnost, o tem obvestijo Komisijo.	Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufacturing an active substance for export has been inspected by a Member State and was found to comply with the principles and guidelines of good manufacturing practice laid down pursuant to the third paragraph of Article 47, the requirement set out in point (b) of paragraph 2 of this Article may be waived by any Member State for a period not exceeding the validity of the certificate of Good Manufacturing Practice. Member States that make use of the possibility of such waiver, shall communicate this to the Commission.
▼B	▼B
Člen 47	Article 47
▼M15	▼M15
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za dopolnitev te direktive z določitvijo načel in smernic dobrih proizvodnih praks za zdravila iz člena 46(f).	The Commission is empowered to adopt delegated acts in accordance with Article 121a in order to supplement this Directive by specifying the principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f).
▼B	▼B
Podrobne smernice, usklajene s temi načeli, bo Komisija objavila in ponovno pregledala ob potrebnem upoštevanju tehničnega in znanstvenega napredka.	Detailed guidelines in line with those principles will be published by the Commission and revised necessary to take account of technical and scientific progress.
▼M11	▼M11
Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme načela in smernice dobre proizvodne prakse za zdravilne učinkovine iz prvega odstavka točke (f) člena 46 in člena 46b.	The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, the principles and guidelines of good manufacturing practice for active substances referred to in the first paragraph of point (f) of Article 46 and in Article 46b.
Načela dobrih distribucijskih praks za zdravilne učinkovine iz prvega odstavka točke (f) člena 46 sprejme Komisija v obliki smernic.	The principles of good distribution practices for active substances referred to in the first paragraph of point (f) of Article 46 shall be adopted by the Commission in the form of guidelines.
Komisija sprejme smernice za formalizirano oceno tveganja za določitev ustrezne dobre proizvodne prakse za pomožne snovi iz drugega odstavka točke (f) člena 46.	The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the second paragraph of point (f) of Article 46.
▼M11	▼M11
Člen 47a	Article 47a
1.	1.
Zaščitni elementi iz točke (o) člena 54 se ne smejo niti delno niti popolnoma odstraniti ali prekriti, razen če so izpolnjeni naslednji pogoji:	The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled:
(a)	(a)
preden imetnik dovoljenja za proizvodnjo deloma ali v celoti odstrani ali prekrije te zaščitne elemente, preveri, da je zadevno zdravilo pristno in da ni bilo nedovoljeno spremenjeno;	the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with;
(b)	(b)
imetnik dovoljenja za proizvodnjo ravna skladno s točko (o) člena 54, tako da te zaščitne elemente nadomesti z zaščitnimi elementi, ki so enakovredni glede možnosti preverjanja avtentičnosti, identifikacije in zagotovitve dokazov o nedovoljenem spreminjanju zdravila. Ta nadomestitev se izvede, ne da bi se odprla stična ovojnina, kakor je opredeljena v točki 23 člena 1.	the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1.
Za zaščitne elemente velja, da so enakovredni, če so:	Safety features shall be considered equivalent if they:
(i)	(i)
v skladu z zahtevami iz delegiranih aktov, sprejetih v skladu s členom 54a(2), in	comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and
(ii)	(ii)
enako učinkoviti pri zagotavljanju preverjanja avtentičnosti in identifikacije zdravila ter pri zagotavljanju dokazov o nedovoljenem spreminjanju zdravil;	are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products;
(c)	(c)
nadomestitev zaščitnih elementov se opravi v skladu z veljavno dobro proizvodno prakso za zdravila; ter	the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and
(d)	(d)
nadomestitev zaščitnih elementov je predmet nadzora pristojnega organa.	the replacement of the safety features is subject to supervision by the competent authority.
2.	2.
Imetniki dovoljenja za proizvodnjo, vključno s tistimi, ki opravljajo dejavnosti, iz odstavka 1 tega člena, veljajo za proizvajalce in zato odgovarjajo za škodo v primerih in pod pogoji, ki so določeni v Direktivi 85/374/EGS.	Manufacturing authorisation holders, including those performing the activities referred to in paragraph 1 of this Article, shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in Directive 85/374/EEC.
▼B	▼B
Člen 48	Article 48
1.	1.
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da ima imetnik dovoljenja za proizvodnjo trajno in nenehno na voljo najmanj eno odgovorno osebo, v skladu s pogoji iz člena 49, ki je odgovorna zlasti za izvajanje dolžnosti, opredeljenih v členu 51.	Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51.
2.	2.
Če imetnik dovoljenja za proizvodnjo osebno izpolnjuje pogoje iz člena 49, lahko sam prevzame odgovornost iz odstavka 1.	If he personally fulfils the conditions laid down in Article 49, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.
▼M16	▼M16
3.	3.
Kadar dovoljenje za proizvodnjo izda pristojni organ Združenega kraljestva v zvezi s Severno Irsko, lahko usposobljena oseba iz odstavka 1 prebiva in deluje v delih Združenega kraljestva razen Severne Irske. Ta odstavek se ne uporablja, kadar ima imetnik dovoljenja za proizvodnjo dne 20. aprila 2022 že na voljo usposobljeno osebo, ki prebiva in deluje v Uniji.	Where the manufacturing authorisation is granted by the competent authority of the United Kingdom in respect of Northern Ireland, the qualified person referred to in paragraph 1 may reside and operate in parts of the United Kingdom other than Northern Ireland. This paragraph shall not apply where the manufacturing authorisation holder already has at its disposal a qualified person who resides and operates in the Union on 20 April 2022.
▼B	▼B
Člen 49	Article 49
1.	1.
Države članice zagotovijo, da odgovorna oseba iz člena 48 izpolnjuje ►M4 ————— ◄ pogoje glede usposobljenosti, določene v odstavkih 2 in 3.	Member States shall ensure that the qualified person referred to in Article 48 fulfils the ►M4 ————— ◄ conditions of qualification set out in paragraphs 2 and 3.
2.	2.
Odgovorna oseba ima diplomo, spričevalo ali drugo dokazilo o formalnih kvalifikacijah, ki se podeljuje ob zaključku univerzitetnega študija ali programa, ki ga zadevna država članica priznava kot enakovrednega, ki obsega najmanj štiri leta teoretičnega in praktičnega študija v eni od naštetih znanstvenih strok: farmacija, medicina, veterinarska medicina, kemija, farmacevtska kemija in tehnologija, biologija.	A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.
Univerzitetni študij lahko traja najmanj tri leta in pol, kadar študiju sledi obdobje teoretičnega in praktičnega usposabljanja, ki traja najmanj eno leto in vključuje najmanj šestmesečno usposabljanje v javni lekarni in se zaključi z izpitom na univerzitetni ravni.	However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.
Kadar v državi članici obstajata hkrati dva univerzitetna programa ali dva izobraževalna programa, ki ju država priznava kot enakovredna, in kadar eden od programov traja štiri leta in drugi tri leta, in če se triletni program zaključi z diplomo, spričevalom ali drugim dokazilom o formalnih kvalifikacijah, ki se podeljuje ob zaključku univerzitetnega študija, ali priznanega enakovrednega programa, se šteje, da kandidat izpolnjuje pogoje trajanja izobraževanja, navedenega v drugem pododstavku, če država članica priznava diplome, spričevala ali druga dokazila o formalnih kvalifikacijah, ki se podeljujejo ob zaključku obeh programov študija, kot enakovredne.	Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.
Program mora obsegati teoretični in praktični del študija, ki temelji na najmanj naslednjih osnovnih predmetih:	The course shall include theoretical and practical study bearing upon at least the following basic subjects:
▼M4	—
—	►M4 Experimental physics ◄
eksperimentalna fizika	—
▼B	General and inorganic chemistry
—	—
splošna in anorganska kemija	Organic chemistry
—	—
organska kemija	Analytical chemistry
—	—
analizna kemija	Pharmaceutical chemistry, including analysis of medicinal products
—	—
farmacevtska kemija, vključno z analizo zdravil	General and applied biochemistry (medical)
—	—
splošna in uporabna biokemija (medicinska)	Physiology
—	—
fiziologija	Microbiology
—	—
mikrobiologija	Pharmacology
—	—
farmakologija	Pharmaceutical technology
—	—
farmacevtska tehnologija	Toxicology
—	—
toksikologija	Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).
—	Studies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 51.
farmakognozija (študij sestave in učinkov naravnih zdravilnih učinkovin rastlinskega in živalskega izvora).	In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved.
Študij teh predmetov mora biti uravnotežen tako, da zadevni osebi omogoča izpolnjevanje pogojev, navedenih v členu 51.	3.
Če diplome, spričevala ali druga dokazila o formalnih kvalifikacijah, omenjeni v prvem pododstavku, ne izpolnjujejo meril, ki jih določa ta odstavek, pristojni organ države članice zagotovi, da zadevna oseba predloži dokaz o ustreznem znanju iz naštetih predmetov.	The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.
3.	The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
Odgovorna oseba v najmanj dveh letih pridobi praktične izkušnje v enem ali več podjetjih, ki imajo dovoljenje za izdelavo zdravil, iz dejavnosti kakovostne analize zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja za potrebe zagotavljanja kakovosti zdravil.	Article 50
Trajanje praktičnega dela se lahko skrajša za eno leto, če univerzitetni program traja najmanj pet let, ter za eno leto in pol, če program traja najmanj šest let.	1.
Člen 50	A person engaging in the activities of the person referred to in Article 48 from the time of the application of Directive 75/319/EEC, in a Member State without complying with the provisions of Article 49 shall be eligible to continue to engage in those activities ►M4 within the Community ◄ .
1.	2.
Oseba, vključena v dejavnosti iz člena 48, je od dneva uporabe Direktive 75/319/EGS v državi članici, ne glede na določbe člena 49, primerna za nadaljevanje opravljanja dejavnosti ►M4 v Skupnosti ◄ .	The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course — or a course recognized as equivalent by the Member State concerned — in a scientific discipline allowing him to engage in the activities of the person referred to in Article 48 in accordance with the laws of that State may — if he began his course prior to 21 May 1975 — be considered as qualified to carry out in that State the duties of the person referred to in Article 48 provided that he has previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings authorized to manufacture: production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 48 to ensure the quality of the medicinal products.
2.	If the person concerned has acquired the practical experience referred to in the first subparagraph before 21 May 1965, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph will be required to be completed immediately before he engages in such activities.
Imetnik diplome, spričevala ali drugega dokazila o formalnih kvalifikacijah, podeljene ob zaključku univerzitetnega študija — ali programa, ki ga zadevna država članica priznava kot enakovrednega — v znanstveni stroki, ki mu omogoča, da opravlja dejavnosti osebe iz člena 48 v skladu z zakonodajo te države — se lahko, če je pričel s programom pred 21. majem 1975 — šteje kot usposobljen za izvajanje nalog iz člena 48 v tej državi, pod pogojem, da je predhodno opravljal naslednje dejavnosti najmanj dve leti pred 21. majem 1985 po uradnem obvestilu o tej direktivi, v enem ali več podjetjih, ki imajo dovoljenje za izdelavo: nadzor proizvodnje in/ali kakovostna in količinska analiza zdravilnih učinkovin, in potrebno preskušanje in preverjanje pod neposrednim nadzorom osebe iz člena 48 za zagotavljanje kakovosti zdravil.	Article 51
Če je zadevna oseba pridobila praktične izkušnje iz prvega pododstavka pred 21. majem 1965, se, v skladu s pogoji iz prvega pododstavka, od osebe zahteva, da pridobi še eno dodatno leto praktičnih izkušenj pred začetkom opravljanja navedene dejavnosti.	1.
Člen 51	Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing:
1.	(a)
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da je odgovorna oseba iz člena 48 brez poseganja v njen odnos z imetnikom dovoljenja za proizvodnjo, odgovorna v smislu postopkov iz člena 52, za zagotavljanje naslednjega:	in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization;
(a)	▼M4
pri zdravilih, ki se proizvajajo v zadevnih državah članicah, da je vsaka posamezna serija zdravil proizvedena in preverjena v skladu z veljavno zakonodajo v tej državi članici ter v skladu z zahtevami dovoljenja za promet z zdravilom;	(b)
▼M4	in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.
(b)	▼M11
pri zdravilih iz tretjih držav, ne glede na to, ali je bilo zdravilo izdelano v Skupnosti, da je bila v državi članici v celoti izvedena kakovostna analiza vsake posamezne serije, količinska analiza vsaj vseh zdravilnih učinkovin ter vsi ostali preskusi ali preverjanja, potrebni za zagotavljanje kakovosti zdravil v skladu z zahtevami dovoljenja za promet z zdravilom.	The qualified person referred to in Article 48 shall in the case of medicinal products intended to be placed on the market in the Union, ensure that the safety features referred to in point (o) of Article 54 have been affixed on the packaging.
▼M11	▼B
Usposobljena oseba iz člena 48 zagotovi, da so pri zdravilih, namenjenih za dajanje v promet v Uniji, zaščitni elementi iz točke (o) člena 54 pritrjeni na ovojnino.	The batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person.
▼B	2.
Serije zdravil, na katerih so bile v državi članici izvedene take kontrole, so oproščene kontrol, če se dajejo v promet v drugi državi članici, priložijo pa se jim poročila o kontroli, s podpisom odgovorne osebe.	In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls.
2.	3.
Pri zdravilih, uvoženih iz tretje države, kadar se Skupnost ustrezno dogovori z državo izvoznico, ki zagotovi, da za proizvajalca zdravila veljajo standardi dobre proizvodne prakse, ki so najmanj enakovredni standardom, predpisanim v Skupnosti, ter da se kontrole iz točke (b) prvega pododstavka odstavka 1 izvedejo v državi izvoznici, je odgovorna oseba razbremenjena odgovornosti za izvedbo teh kontrol.	In all cases and particularly where the medicinal products are released for sale, the qualified person must certify in a register or equivalent document provided for that purpose, that each production batch satisfies the provisions of this Article; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member State concerned and in any event for at least five years.
3.	Article 52
V vseh primerih, zlasti kadar se zdravila dajo v promet, mora usposobljena oseba potrditi v registru ali enakovrednem dokumentu, predpisanem za ta namen, da vsaka posamezna proizvodna serija izpolnjuje določbe tega člena; ta register ali enakovredni dokument je treba ažurirati z zadnjimi podatki v zvezi z opravljenim delom in mora biti na voljo zastopnikom pristojnega organa tako dolgo, kot to predvidevajo določbe zadevne države članice, v vsakem primeru pa najmanj pet let.	Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.
Člen 52	Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary procedures against him for failure to fulfil his obligations.
Države članice z ustreznimi upravnimi ukrepi ali z zavezo, da je odgovorna oseba dolžna ravnati v skladu s strokovnim kodeksom ravnanja, zagotovijo, da odgovorna oseba iz člena 48 izpolnjuje svoje dolžnosti.	▼M11
Države članice lahko predpišejo, da se taka oseba začasno suspendira, če je bil proti njej sprožen upravni ali disciplinski postopek zaradi neizpolnjevanja obveznosti.	Article 52a
▼M11	1.
Člen 52a	Importers, manufacturers and distributors of active substances who are established in the Union shall register their activity with the competent authority of the Member State in which they are established.
1.	2.
Proizvajalci, uvozniki in distributerji zdravilnih učinkovin, ki imajo sedež v Uniji, registrirajo svojo dejavnost pri pristojnem organu države članice, v kateri imajo sedež.	The registration form shall include, at least, the following information:
2.	(i)
Obrazec za registracijo vključuje vsaj naslednje informacije:	name or corporate name and permanent address;
(i)	(ii)
ime ali naziv podjetja in stalni naslov;	the active substances which are to be imported, manufactured or distributed;
(ii)	(iii)
zdravilne učinkovine, ki bodo predmet uvoza, proizvodnje ali distribucije;	particulars regarding the premises and the technical equipment for their activity.
(iii)	3.
podatke o prostorih in tehnični opremi za njihovo dejavnost.	The persons referred to in paragraph 1 shall submit the registration form to the competent authority at least 60 days prior to the intended commencement of their activity.
3.	4.
Osebe iz odstavka 1 predložijo obrazec za registracijo pristojnemu organu najmanj 60 dni pred nameravanim začetkom njihove dejavnosti.	The competent authority may, based on a risk assessment, decide to carry out an inspection. If the competent authority notifies the applicant within 60 days of the receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority has notified the applicant that he may commence the activity. If within 60 days of the receipt of the registration form the competent authority has not notified the applicant that an inspection will be carried out, the applicant may commence the activity.
4.	5.
Pristojni organ se lahko na podlagi ocene tveganja odloči, da opravi inšpekcijski pregled. Če pristojni organ v 60 dneh od prejema obrazca za registracijo obvesti vlagatelja, da bo izveden inšpekcijski pregled, se dejavnost ne začne izvajati, dokler pristojni organ vlagatelja ne obvesti, da jo lahko začne izvajati. Če pristojni organ 60 dni po prejemu obrazca za registracijo vlagatelja ne obvesti, da bo izveden inšpekcijski pregled, lahko vlagatelj začne izvajati dejavnost.	The persons referred to in paragraph 1 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in the registration form. Any changes that may have an impact on the quality or safety of the active substances that are manufactured, imported or distributed must be notified immediately.
5.	6.
Osebe iz odstavka 1 pristojnemu organu letno sporočijo popis sprememb, ki so nastale glede informacij, zagotovljenih v obrazcu za registracijo. Vse spremembe, ki bi lahko vplivale na kakovost ali varnost zdravilnih učinkovin, ki so predmet proizvodnje, uvoza ali distribucije, je treba nemudoma sporočiti.	Persons referred to in paragraph 1 who had commenced their activity before 2 January 2013 shall submit the registration form to the competent authority by 2 March 2013.
6.	7.
Osebe iz odstavka 1, ki so začele svojo dejavnost pred 2. januarjem 2013, pristojnemu organu obrazec za registracijo predložijo do 2. marca 2013.	Member States shall enter the information provided in accordance with paragraph 2 of this Article in the Union database referred to in Article 111(6).
7.	8.
Države članice informacije, zagotovljene v skladu z odstavkom 2 tega člena, vnesejo v podatkovno bazo Unije iz člena 111(6).	This Article shall be without prejudice to Article 111.
8.	Article 52b
Ta člen ne posega v člen 111.	1.
Člen 52b	Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall take the necessary measures in order to prevent medicinal products that are introduced into the Union, but are not intended to be placed on the market of the Union, from entering into circulation if there are sufficient grounds to suspect that those products are falsified.
1.	2.
Ne glede na člen 2(1) in brez poseganja v naslov VII države članice sprejmejo potrebne ukrepe za preprečitev, da se zdravila, ki so vnesena v Unijo, vendar niso namenjena dajanju v promet v Uniji, sprostijo v promet, če obstaja utemeljen sum, da so ta zdravila ponarejena.	In order to establish what the necessary measures referred to in paragraph 1 of this Article are, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions laid down in Articles 121b and 121c, measures supplementing paragraph 1 of this Article as regards the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced into the Union but not intended to be placed on the market.
2.	▼B
Za določitev, kaj so potrebni ukrepi iz odstavka 1 tega člena, lahko Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme ukrepe, ki dopolnjujejo določbe odstavka 1 tega člena, kar zadeva merila, ki jih je treba upoštevati, ter preverjanje, ki ga je treba opraviti pri oceni verjetnosti, da gre za ponarejena zdravila, ki so bila vnesena v Unijo, vendar niso namenjena dajanju v promet.	Article 53
▼B	The provisions of this Title shall also apply to homeopathic medicinal products.
Člen 53	TITLE V
Določbe tega naslova se uporabljajo tudi za homeopatska zdravila.	LABELLING AND PACKAGE LEAFLET
NASLOV V	Article 54
OZNAČEVANJE IN NAVODILO ZA UPORABO	The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
Člen 54	▼M4
Na zunanji ovojnini ali, kadar zunanje ovojnine ni, na stični ovojnini zdravil se navedejo naslednji podatki:	(a)
▼M4	the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;
(a)	▼B
ime zdravila, ki mu sledi jakost in farmacevtska oblika in, če je to ustrezno, ali je zdravilo namenjeno dojenčkom, otrokom ali odraslim; če zdravilo vsebuje največ tri zdravilne učinkovine, je treba dodati mednarodno nelastniško ime (INN) ali, če to ne obstaja, splošno ime;	(b)
▼B	a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
(b)	(c)
kakovostna in količinska navedba zdravilnih učinkovin, izražena na enoto odmerka, ali glede na način uporabe zdravila za dano prostornino ali maso, z uporabo splošnih imen;	the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
(c)	(d)
farmacevtsko obliko in vsebino, izraženo v enotah mase, prostornine ali v številu odmerkov zdravila;	a list of those excipients known to have a recognized action or effect and included in the ►M4 detailed guidance ◄ published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
(d)	▼M4
seznam pomožnih snovi, za katera je znano, da imajo priznano delovanje ali učinek in so vključena v ►M4 podrobne smernice ◄ , objavljene v skladu s členom 65. Če se zdravilo injicira ali je namenjeno topikalni uporabi ali uporabi za oči, je treba navesti vse pomožne snovi;	(e)
▼M4	the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
(e)	(f)
postopek, in če je potrebno, pot uporabe zdravila. Zagotoviti je treba prostor, kamor se vpiše predpisan odmerek zdravila;	a special warning that the medicinal product must be stored out of the reach and sight of children;
(f)	▼B
posebno opozorilo, da je zdravilo treba shranjevati nedosegljivo otrokom;	(g)
▼B	a special warning, if this is necessary for the medicinal product;
(g)	(h)
posebno opozorilo, če je glede na zdravilo to potrebno;	the expiry date in clear terms (month/year);
(h)	(i)
jasno izražen datum izteka roka uporabnosti (mesec/leto);	special storage precautions, if any;
(i)	▼M4
posebna navodila za shranjevanje, če obstajajo;	(j)
▼M4	specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;
(j)	(k)
posebni varnostni ukrepi za odstranjevanje neuporabljenih zdravil ali iz njih nastalih odpadnih snovi, če je to primerno, kot tudi napotitev na vsak ustrezen uveljavljen sistem zbiranja teh snovi;	the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;
(k)	▼B
ime in naslov imetnika dovoljenja za promet z zdravilom in, če je to primerno, ime predstavnika, ki ga za zastopanje imenuje imetnik dovoljenja za promet;	(l)
▼B	the number of the authorization for placing the medicinal product on the market;
(l)	(m)
številko dovoljenja za promet z zdravilom;	the manufacturer's batch number;
(m)	▼M4
proizvajalčeva številka serije;	(n)
▼M4	in the case of non-prescription medicinal products, instructions for use;
(n)	▼M11
če gre za zdravila, ki se izdajajo brez recepta, navodila za uporabo zdravil;	(o)
▼M11	for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:
(o)	—
za zdravila, ki niso radiofarmacevtski izdelki iz člena 54a(1), zaščitni elementi, ki trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogočajo, da:	verify the authenticity of the medicinal product, and
—	—
preverijo avtentičnost zdravila, in	identify individual packs,
—	as well as a device allowing verification of whether the outer packaging has been tampered with.
identificirajo posamezne zavitke,	Article 54a
ter tudi napravo, ki omogoča preverjanje, ali je bila zunanja ovojnina nedovoljeno spremenjena.	1.
Člen 54a	Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article.
1.	Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification.
Zdravila, ki se izdajajo na recept, nosijo zaščitne elemente iz točke (o) člena 54, razen če so bila uvrščena na seznam v skladu s postopkom iz točke (b) odstavka 2 tega člena.	2.
▼C3	The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54.
Zdravila, ki se ne izdajajo na recept, ne smejo nositi zaščitnih elementov iz točke (o) člena 54, razen če so izjemoma uvrščena na seznam v skladu s postopkom iz točke (b) odstavka 2 tega člena, potem ko je bilo ocenjeno, da zanje velja tveganje ponarejanja.	Those delegated acts shall set out:
▼M11	(a)
2.	the characteristics and technical specifications of the unique identifier of the safety features referred to in point (o) of Article 54 that enables the authenticity of medicinal products to be verified and individual packs to be identified. When establishing the safety features due consideration shall be given to their cost-effectiveness;
Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme ukrepe, ki dopolnjujejo določbe iz točke (o) člena 54, z namenom, da bi določila podrobna pravila za zaščitne elemente iz točke (o) člena 54.	(b)
Navedeni delegirani akti določajo:	the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54. Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. To this end, at least the following criteria shall be applied:
(a)	(i)
značilnosti in tehnične specifikacije edinstvene oznake za zaščitne elemente iz točke (o) člena 54, ki omogočajo preverjanje avtentičnosti zdravil in identifikacijo posameznih pakiranj. Pri določanju zaščitnih elementov se ustrezno upošteva njihova stroškovna učinkovitost;	the price and sales volume of the medicinal product;
►C3 (b)	(ii)
sezname zdravil ali kategorij zdravil, kateri v primeru zdravil, ki se izdajajo na recept, ne smejo nositi zaščitnih elementov, v primeru zdravil, ki se izdajajo brez recepta, pa morajo nositi zaščitne elemente iz točke (o) člena 54. ◄ Te sezname se oblikuje ob upoštevanju tveganja ponarejanja in tveganja, ki izvira iz ponareditve, povezanih z zdravili ali kategorijami zdravil. V ta namen se uporabi vsaj naslednja merila:	the number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date;
(i)	(iii)
ceno in obseg prodaje zdravila;	the specific characteristics of the medicinal products concerned;
(ii)	(iv)
število in pogostost preteklih zabeleženih primerov ponarejenih zdravil v Uniji in tretjih državah ter razvoj števila in pogostosti takšnih primerov do danes;	the severity of the conditions intended to be treated;
(iii)	(v)
posebne značilnosti zadevnih zdravil;	other potential risks to public health;
(iv)	(c)
resnost bolezni, katerih zdravljenju so namenjena;	the procedures for the notification to the Commission provided for in paragraph 4 and a rapid system for evaluating and deciding on such notification for the purpose of applying point (b);
(v)	(d)
druga možna tveganja za javno zdravje;	the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification. When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account;
(c)	(e)
postopke iz odstavka 4 za obvestitev Komisije ter hiter sistem za ocenjevanje in odločanje o teh obvestilih za namene izvajanja točke (b);	provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.
(d)	3.
načine preverjanja zaščitnih elementov iz točke (o) člena 54, ki jih uporabljajo proizvajalci, trgovci na debelo, farmacevti in osebe, ki imajo dovoljenje ali pravico do izdajanja zdravil javnosti, ter pristojni organi. Ti načini omogočajo preverjanje avtentičnosti vsakega dobavljenega pakiranja zdravila, ki nosi zaščitne elemente iz točke (o) člena 54 ter določajo obseg preverjanja. Pri oblikovanju teh načinov se upošteva posebne značilnosti dobavnih verig v državah članicah ter potrebo po zagotovitvi, da bodo imeli ukrepi preverjanja sorazmeren učinek na posamezne udeležence v dobavni verigi;	When adopting the measures referred to in paragraph 2, the Commission shall take due account of at least the following:
(e)	(a)
določbe o oblikovanju, upravljanju in dostopnosti sistemov arhivov, v katerih so zbrane informacije o zaščitnih elementih, ki omogočajo preverjanje avtentičnosti in identifikacijo zdravil, kot je določeno v točki (o) člena 54. Stroške sistemov arhivov krijejo imetniki dovoljenja za proizvodnjo zdravil, ki nosijo zaščitne elemente.	the protection of personal data as provided for in Union law;
3.	(b)
Pri sprejemanju ukrepov iz odstavka 2 Komisija primerno upošteva vsaj naslednje:	the legitimate interests to protect information of a commercially confidential nature;
(a)	(c)
varstvo osebnih podatkov, kot je določeno v zakonodaji Unije;	the ownership and confidentiality of the data generated by the use of the safety features; and
(b)	(d)
legitimne interese glede varovanja poslovno zaupnih informacij;	the cost-effectiveness of the measures.
(c)	4.
lastništvo in zaupnost podatkov, ki nastanejo z uporabo zaščitnih elementov, in	The national competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification and may inform the Commission of medicinal products which they deem not to be at risk according to the criteria set out in point (b) of paragraph 2 of this Article.
(d)	5.
stroškovno učinkovitost ukrepov.	Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement.
4.	Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article.
Pristojni nacionalni organi obvestijo Komisijo o neizdajanju zdravil, za katera domnevajo, da obstaja tveganje ponarejanja, ter jo lahko obvestijo o zdravilih, za katera menijo, da ni nevarnosti v skladu z merili iz točke (b) odstavka 2 tega člena.	Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product.
5.	▼B
Države članice lahko za namene povračila ali farmakovigilance razširijo področje uporabe edinstvene oznake iz točke (o) člena 54 na vsa zdravila, ki se izdajajo na recept ali za katera velja povračilo.	Article 55
Države članice lahko za namene povračila, farmakovigilance ali farmakoepidemiologije uporabijo informacije iz sistema arhivov iz točke (e) odstavka 2 tega člena.	1.
Države članice lahko za namene varnosti bolnikov, razširijo področje uporabe sredstva za preprečevanje nedovoljenega spreminjanja iz točke (o) člena 54 na vsa zdravila.	The particulars laid down ►M4 in Article 54 ◄ shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.
▼B	2.
Člen 55	The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62.
1.	▼M4
Vsi podrobni podatki ►M4 iz člena 54 ◄ se navedejo na stičnih ovojninah, razen tistih, omenjenih v odstavkih 2 in 3.	—
2.	the name of the medicinal product as laid down in point (a) of Article 54,
Na stični ovojnini v obliki pretisnega omota, ki je vložen v zunanjo ovojnino, ki je v skladu z zahtevami iz členov 54 in 62, se navedejo najmanj naslednji podatki:	▼B
▼M4	—
—	the name of the holder of the authorization for placing the product on the market,
ime zdravila, kakor je določeno v točki (a) člena 54,	—
▼B	the expiry date,
—	—
ime imetnika dovoljenja za promet z zdravilom,	the batch number.
—	3.
datum izteka roka uporabnosti,	The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed:
—	▼M4
številka serije.	—
3.	the name of the medicinal product as laid down in point (a) of Article 54 and, if necessary, the route of administration,
Na majhnih stičnih ovojninah, na katerih podatkov iz členov 54 in 62 ni mogoče navesti, se navedejo najmanj naslednji podatki:	▼B
▼M4	—
—	the method of administration,
ime zdravila, kakor je določeno v točki (a) člena 54 in, če je potrebno, pot uporabe zdravila,	—
▼B	the expiry date,
—	—
postopek uporabe zdravila,	the batch number,
—	—
datum izteka roka uporabnosti,	the contents by weight, by volume or by unit.
—	Article 56
številka serije,	The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.
—	▼M4
vsebina, izražena z maso, prostornino ali enoto.	Article 56a
Člen 56	The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted.
Podatki iz členov 54, 55 in 62 morajo biti čitljivi, razumljivi in neizbrisljivi.	▼B
▼M4	Article 57
Člen 56a	Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:
Ime zdravila, kot je navedeno v točki (a) člena 54 mora biti na ovojnini izpisano tudi v Braillovi pisavi. Imetnik dovoljenja za promet z zdravilom zagotovi, da so na zahtevo organizacij bolnikov navodilo za uporabo in ostale informacije o zdravilu na voljo v oblikah, ki so primerne za slepe in slabovidne.	—
▼B	the price of the medicinal product,
Člen 57	—
Ne glede na člen 60, lahko države članice zahtevajo uporabo nekaterih posebnih oznak zdravil, da s tem omogočijo ugotavljanje:	the reimbursement conditions of social security organizations,
—	—
cene zdravila,	the legal status for supply to the patient, in accordance with Title VI,
—	▼M11
pogojev za nadomestilo stroškov organizacij socialne varnosti,	—
—	authenticity and identification in accordance with Article 54a(5).
pravni status glede izdajanja zdravila bolniku v skladu z naslovom VI,	▼M4
▼M11	For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive.
—	▼B
avtentičnost in identifikacija v skladu s členom 54a(5).	Article 58
▼M4	The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging.
Za zdravilo, ki je pridobilo dovoljenje za promet na podlagi Uredbe (ES) št. 726/2004, države članice pri uporabi tega člena upoštevajo podrobne smernice iz člena 65 te direktive.	▼M4
▼B	Article 59
Člen 58	1.
V pakiranje zdravila je treba obvezno priložiti navodilo za uporabo, če niso vse informacije, ki jih zahtevata člena 59 in 62, neposredno navedene na zunanji ali na stični ovojnini.	The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
▼M4	(a)
Člen 59	for the identification of the medicinal product:
1.	(i)
Navodilo za uporabo je sestavljeno v skladu s povzetkom glavnih značilnosti zdravila; v naslednjem vrstnem redu vsebuje:	the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name;
(a)	(ii)
za identifikacijo zdravila:	the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient;
(i)	(b)
ime zdravila, ki mu sledi jakost in farmacevtska oblika in, če je ustrezno, navedba, ali je zdravilo namenjeno dojenčkom, otrokom ali odraslim. Splošno ime se navede, če zdravilo vsebuje le eno zdravilno učinkovino in če je ime izmišljeno;	the therapeutic indications;
(ii)	(c)
farmakoterapevtsko skupino ali način delovanja v bolniku lahko razumljivem jeziku;	a list of information which is necessary before the medicinal product is taken:
(b)	(i)
terapevtske indikacije;	contra-indications;
(c)	(ii)
seznam podatkov, ki jih je treba poznati pred uporabo zdravila:	appropriate precautions for use;
(i)	(iii)
kontraindikacije;	forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
(ii)	(iv)
ustrezni previdnostni ukrepi za uporabo;	special warnings;
(iii)	(d)
oblike medsebojnega delovanja z drugimi zdravili ter druge oblike interakcij (npr. alkohol, tobak, hrana), ki lahko vplivajo na delovanje zdravila;	the necessary and usual instructions for proper use, and in particular:
(iv)	(i)
posebna opozorila;	the dosage,
(d)	(ii)
običajni podatki, ki so potrebni za pravilno uporabo, zlasti:	the method and, if necessary, route of administration;
(i)	(iii)
odmerjanje,	the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered;
(ii)	and, as appropriate, depending on the nature of the product:
postopek, in če je potrebno, pot uporabe zdravila;	(iv)
(iii)	the duration of treatment, where it should be limited;
pogostost uporabe zdravila, po potrebi z navedbo primernega časa, ko se zdravilo sme ali mora jemati; in če je to primerno, odvisno od narave zdravila:	(v)
(iv)	the action to be taken in case of an overdose (such as symptoms, emergency procedures);
trajanje zdravljenja, kadar bi moralo biti omejeno;	(vi)
(v)	what to do when one or more doses have not been taken;
ukrepi, ki jih je treba sprejeti v primeru prevelikega odmerjanja (npr. simptomi, nujni postopki);	(vii)
(vi)	indication, if necessary, of the risk of withdrawal effects;
način ukrepanja, če je bolnik izpustil enega ali več odmerkov;	(viii)
(vii)	a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;
navedba, če je to potrebno, glede tveganja zaradi učinkov ob prenehanju jemanja zdravil;	▼M10
(viii)	(e)
posebno priporočilo, da se glede pojasnil o uporabi zdravila posvetujemo z zdravnikom ali farmacevtom;	a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case;
▼M10	▼M4
(e)	(f)
opis neželenih učinkov, ki se lahko pojavijo pri običajni uporabi zdravila in po potrebi ukrepe, ki jih je treba sprejeti v takem primeru;	a reference to the expiry date indicated on the label, with:
▼M4	(i)
(f)	a warning against using the product after that date;
napotitev glede datuma izteka roka uporabnosti, navedenega na ovojnini, z:	(ii)
(i)	where appropriate, special storage precautions;
opozorilom, da se zdravilo po navedenem datumu izteka roka uporabnosti ne sme uporabljati;	(iii)
(ii)	if necessary, a warning concerning certain visible signs of deterioration;
kadar je primerno, posebnimi navodili za shranjevanje;	(iv)
(iii)	the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product;
kadar je potrebno, opozorilom v zvezi z določenimi vidnimi znaki kvarjenja;	(v)
(iv)	for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;
popolno kakovostno sestavo (zdravilnih učinkovin in pomožnih snovi) ter količinsko sestavo zdravilnih učinkovin, z uporabo splošnih imen, posebej za vsako obliko pakiranja zdravila;	(vi)
(v)	the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
za vsako obliko pakiranja zdravila, farmacevtsko obliko in vsebino v masi, prostornini ali enotah odmerkov;	(vii)
(vi)	the name and address of the manufacturer;
imenom in naslovom imetnika dovoljenja za promet z zdravilom in, če je to primerno, imenom predstavnika, ki ga imetnik dovoljenja imenuje v državah članicah;	(g)
(vii)	where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State;
imenom in naslovom izdelovalca;	(h)
(g)	the date on which the package leaflet was last revised.
če je zdravilo pridobilo dovoljenje za promet v skladu s členi 28 do 39 pod različnimi imeni v zadevnih državah članicah, seznam odobrenih imen v vsaki državi članici;	▼M10
(h)	For medicinal products included in the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726/2004 and followed by an appropriate standardised explanatory sentence.
datum zadnje revizije navodila za uporabo.	For all medicinal products, a standardised text shall be included, expressly asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system referred to in Article 107a(1), and specifying the different ways of reporting available (electronic reporting, postal address and/or others) in compliance with the second subparagraph of Article 107a(1).
▼M10	▼M4
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja dodatna izjava: „Za to zdravilo se izvaja dodatno spremljanje varnosti.“. Pred to izjavo je črn simbol iz člena 23 Uredbe (ES) št. 726/2004, sledi pa ji standardna kratka obrazložitev.	2.
Vsem zdravilom se doda standardno besedilo, ki od bolnikov izrecno zahteva, naj vsak domnevni neželeni učinek sporočijo svojemu zdravniku, farmacevtu, zdravstvenemu delavcu ali neposredno nacionalnemu sistemu spontanega poročanja iz člena 107a(1), ob tem pa se navedejo različni načini poročanja, ki so na voljo (elektronsko poročanje, poštna številka in/ali drugo) v skladu z drugim pododstavkom člena 107a(1).	The list set out in point (c) of paragraph 1 shall:
▼M4	(a)
2.	take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions);
Seznam iz točke (c) odstavka 1:	(b)
(a)	mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery;
upošteva posebne pogoje nekaterih skupin uporabnikov (otrok, nosečnic ali doječih mater, starejših, oseb s posebnimi patološkimi stanji);	(c)
(b)	list those excipients knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65.
omeni, če je to ustrezno, morebitne učinke na sposobnost vožnje ali upravljanja s stroji;	3.
(c)	The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
navede tiste pomožne snovi, za katere je znano, da so pomembne za varno in učinkovito uporabo zdravil in ki so zajete v podrobnih smernicah, objavljenih v skladu s členom 65.	▼M10
3.	4.
Navodilo za uporabo odraža rezultate posvetovanja s ciljnimi skupinami bolnikov z namenom zagotoviti, da so berljiva, jasna in enostavna za uporabo.	By 1 January 2013, the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. The Commission shall, if appropriate, and on the basis of the report, and consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.
▼M10	▼B
4.	Article 60
Komisija do 1. januarja 2013 Evropskemu parlamentu in Svetu predloži poročilo o oceni trenutnih pomanjkljivostih v povzetku glavnih značilnosti zdravila in navodilu za uporabo ter predloge za njihovo izboljšanje, da bi bolje zadovoljili potrebe bolnikov in zdravstvenih delavcev. Komisija, če je to primerno, na podlagi poročila in posvetovanja z zadevnimi stranmi, pripravi predloge za izboljšanje berljivosti, predstavitve in vsebine teh dokumentov.	Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title.
▼B	Article 61
Člen 60	▼M4
Na svojem ozemlju države članice ne smejo prepovedati ali ovirati dajanja zdravil v promet v zvezi z označevanjem ali navodilom za uporabo, kadar sta v skladu z zahtevami tega naslova.	1.
Člen 61	One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.
▼M4	▼B
1.	2.
V vlogi za pridobitev dovoljenja za promet se organom, pristojnim za izdajo dovoljenja za promet z zdravilom, predloži eden ali več osnutkov zunanje in stične ovojnine zdravila ter osnutek navodila za uporabo. Pristojnemu organu se sporočijo tudi rezultati ocen, opravljenih v sodelovanju s ciljnimi skupinami bolnikov.	The competent authority shall refuse the marketing authorization if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics.
▼B	3.
2.	All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.
Pristojni organ zavrne pridobitev dovoljenja za promet z zdravilom, če označevanje ali navodilo za uporabo nista v skladu z določbami tega naslova ali če nista v skladu s podrobnimi podatki iz povzetka glavnih značilnosti zdravila.	4.
3.	The fact that the competent authority do not refuse a marketing authorization pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer ►M4 and ◄ the marketing authorization holder.
Vse predlagane spremembe z vidika označevanja ali navodila za uporabo, zajete v tem naslovu, ki niso povezane s povzetkom glavnih značilnosti zdravila, se predložijo organom, pristojnim za izdajo dovoljenja za promet z zdravilom. Če pristojni organi ne nasprotujejo predlagani spremembi v 90 dneh po predložitvi vloge, vlagatelj spremembo lahko uveljavi.	Article 62
4.	The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful ►M4 for the patient ◄ , to the exclusion of any element of a promotional nature.
Dejstvo, da pristojni organ ne zavrne pridobitve dovoljenja za promet z zdravilom na podlagi odstavka 2, ali spremembe označevanja ali navodila za uporabo na podlagi odstavka 3, ne spremeni splošne pravne odgovornosti proizvajalca ►M4 in ◄ imetnika dovoljenja za promet z zdravilom.	Article 63
Člen 62	▼M12
Zunanja ovojnina in navodilo za uporabo lahko vsebujeta simbole ali piktograme, katerih namen je razjasnitev nekaterih informacij iz členov 54 in 59(1) in drugih informacij v skladu s povzetkom glavnih značilnosti zdravila, ki so koristne ►M4 za bolnika ◄ , z izjemo vseh elementov, ki so promocijske narave.	1.
Člen 63	The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
▼M12	▼B
1.	The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.
Podrobni podatki za označevanje iz členov 54, 59 in 62 so napisani v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa navedena država članica.	▼M4
▼B	In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community.
Prvi pododstavek ne preprečuje navedbe teh podrobnih podatkov v več jezikih pod pogojem, da se isti podatki navedejo v vseh jezikih, ki se uporabljajo.	▼M12
▼M4	2.
Za nekatera zdravila sirote se podrobni podatki iz člena 54 lahko na podlagi utemeljene zahteve navedejo samo v enem izmed uradnih jezikov Skupnosti.	The package leaflet must be written and designed in such a way as to be clear and understandable, enabling users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
▼M12	▼M4
2.	The first subparagraph shall not prevent the package leaflet from being printed in several languages, provided that the same information is given in all the languages used.
Navodilo za uporabo mora biti napisano in oblikovano na jasen ter razumljiv način, ki uporabnikom omogoča pravilno ravnanje, če je potrebno tudi s pomočjo zdravstvenega osebja. Navodilo za uporabo mora biti jasno berljivo v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa navedena država članica.	▼M12
▼M4	3.
Prvi pododstavek na preprečuje tiskanja navodil za uporabo v več jezikih pod pogojem, da se iste informacije navedejo v vseh jezikih, ki se uporabljajo.	Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
▼M12	▼B
3.	Article 64
Kadar zdravilo ni namenjeno neposredni dobavi bolniku ali kadar obstajajo resne težave v zvezi z dostopnostjo zdravila, lahko pristojni organi ob upoštevanju ukrepov, za katere menijo, da so potrebni za varovanje zdravja ljudi, odobrijo izjemo od obveznosti, v skladu s katero bi morali biti na ovojnini in v navodilu za uporabo navedeni nekateri podrobni podatki. Odobrijo lahko tudi celotno ali delno izjemo od obveznosti, da morata biti ovojnina in navodilo za uporabo v uradnem jeziku ali uradnih jezikih države članice, kjer je zdravilo v prometu, kakor za namene te direktive določa ta država članica.	Where the provisions of this Title are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorization, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Title.
▼B	▼M4
Člen 64	Article 65
Kadar se določbe tega naslova ne upoštevajo in se zadevna oseba ne odzove na poslani opomin, pristojni organi države članice lahko začasno umaknejo dovoljenje za promet z zdravilom, dokler sporna ovojnina in navodilo za uporabo zdravila nista v skladu z zahtevami tega naslova.	In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:
▼M4	(a)
Člen 65	the wording of certain special warnings for certain categories of medicinal products;
V posvetovanju z državami članicami in zadevnimi strankami, Komisija pripravlja in objavlja zlasti podrobne smernice o:	(b)
(a)	the particular information needs relating to non-prescription medicinal products;
obliki navajanja nekaterih posebnih opozoril za določene skupine zdravil;	(c)
(b)	the legibility of particulars on the labelling and package leaflet;
potrebah po določenih informacijah v zvezi z zdravili, ki se izdajajo brez recepta;	(d)
(c)	the methods for the identification and authentication of medicinal products;
čitljivosti podrobnih podatkov na ovojnini in navodilu za uporabo;	(e)
(d)	the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated;
načinih za identifikacijo in ugotavljanje avtentičnosti zdravil;	(f)
(e)	harmonised provisions for the implementation of Article 57.
seznamu pomožnih snovi, ki jih je treba navesti na ovojnini zdravil, ter načinu, kako je treba te pomožne snovi navesti;	▼B
(f)	Article 66
usklajenih določbah za izvajanje člena 57.	1.
▼B	The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3.
Člen 66	2.
1.	The label on the shielding shall include the particulars mentioned in Article 54. In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.
Zunanja ovojnina in vsebnik zdravil, ki vsebujejo radionuklide, se označita v skladu s predpisi o varnem prevozu radioaktivnih snovi, ki jih je določila Mednarodna agencija za atomsko energijo. Oznaka mora biti tudi v skladu z določbami odstavkov 2 in 3.	3.
2.	The vial shall be labelled with the following information:
Nalepka na zaščitni ovojnini vsebuje podrobne podatke iz člena 54. Nalepka na zaščitni ovojnini v celoti pojasnjuje uporabljene kode na viali in navaja, kadar je to potrebno, za navedeni čas in datum, skupno radioaktivnost na odmerek ali na vialo, ter število kapsul ali, pri tekočinah, število mililitrov v vsebniku.	—
3.	the name or code of the medicinal product, including the name or chemical symbol of the radionuclide,
Na viali so oznake z naslednjimi informacijami:	—
—	the batch identification and expiry date,
ime ali koda zdravila, vključno z imenom ali kemijskim simbolom radionuklida,	—
—	the international symbol for radioactivity,
identifikacija serije ter datum izteka roka uporabnosti,	▼M4
—	—
mednarodni simbol za radioaktivnost,	the name and address of the manufacturer,
▼M4	▼B
—	—
ime in naslov izdelovalca,	the amount of radioactivity as specified in paragraph 2.
▼B	Article 67
—	The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in accordance with the provisions of Article 59. In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents.
skupno radioaktivnost, kakor je navedeno v odstavku 2.	Article 68
Člen 67	Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.
Pristojni organ zagotovi, da je v vsakem pakiranju pri radiofarmacevtskih izdelkih, radionuklidnih generatorjih, radionuklidnih kompletih ali radionuklidnih predhodnikih priloženo podrobno navodilo za uporabo. Besedilo navodila za uporabo je sestavljeno v skladu z določbami člena 59. Navodilo za uporabo poleg tega vključuje tudi varnostne ukrepe, ki jih morata uporabnik in bolnik upoštevati med pripravo in dajanjem zdravila, ter posebne varnostne ukrepe za odstranjevanje ovojnine in neuporabljene vsebine.	Article 69
Člen 68	1.
Brez poseganja v določbe člena 69 se homeopatska zdravila označujejo v skladu z določbami tega naslova, na ovojnini pa mora biti v jasni in čitljivi obliki oznaka o homeopatski naravi izdelka.	In addition to the clear mention of the words ‘homeopathic medicinal product’, the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information:
Člen 69	▼M4
1.	—
Poleg jasne navedbe besed „homeopatsko zdravilo“, ovojnina, in kadar je to primerno, navodilo za uporabo zdravila iz člena 14(1), vsebuje tudi naslednje in nobenih drugih informacij:	the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5); if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name,
▼M4	▼B
—	—
znanstveno ime homeopatske surovine ali surovin, ki mu sledi stopnja razredčitve z uporabo simbolov iz farmakopeje, v skladu s členom 1(5); če je homeopatsko zdravilo sestavljeno iz dveh ali več surovin, se lahko poleg znanstvenih imen surovin na ovojnini navede tudi izmišljeno ime,	name and address of the registration holder and, where appropriate, of the manufacturer,
▼B	—
—	method of administration and, if necessary, route,
ime in naslov osebe, odgovorne za dajanje zdravila v promet, in kadar je to primerno, proizvajalca,	—
—	expiry date, in clear terms (month, year),
postopek uporabe homeopatskega zdravila, in če je potrebno, pot,	—
—	pharmaceutical form,
jasno naveden datum izteka roka uporabnosti (mesec, leto),	—
—	contents of the sales presentation,
farmacevtsko obliko,	—
—	special storage precautions, if any,
vsebina pakiranja, ki je v prodaji,	—
—	a special warning if necessary for the medicinal product,
posebna navodila za shranjevanje, če obstajajo,	—
—	manufacturer's batch number,
posebno opozorilo za zdravilo, če je potrebno,	—
—	registration number,
proizvajalčeva številka serije,	—
—	‘homeopathic medicinal product without approved therapeutic indications’,
številko registracije,	▼M4
—	—
„homeopatsko zdravilo brez odobrenih terapevtskih indikacij“,	a warning advising the user to consult a doctor if the symptoms persist.
▼M4	▼B
—	2.
opozorilo z nasvetom uporabniku, da se posvetuje z zdravnikom, če se znaki bolezni ne izboljšajo.	Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:
▼B	—
2.	the price of the medicinal product,
Ne glede na odstavek 1, države članice lahko zahtevajo uporabo nekaterih vrst oznak za prikaz:	—
—	the conditions for refunds by social security bodies.
cene zdravila,	TITLE VI
—	CLASSIFICATION OF MEDICINAL PRODUCTS
pogoje za nadomestilo s strani organov socialnega varstva.	Article 70
NASLOV VI	1.
RAZVRŠČANJE ZDRAVIL	When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into:
Člen 70	—
1.	a medicinal product subject to medical prescription,
Ko je dovoljenje za promet z zdravilom izdano, pristojni organi razvrstijo zdravilo v skupino:	—
—	a medicinal product not subject to medical prescription.
zdravil, ki se izdajajo le na recept,	To this end, the criteria laid down in Article 71(1) shall apply.
—	2.
zdravil, ki se izdajajo brez recepta.	The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification:
V ta namen se uporabljajo merila iz člena 71(1).	▼M4
2.	(a)
Pristojni organi lahko določijo podskupine za zdravila, ki se izdajajo le na recept. Podskupine so naslednje:	medicinal products on medical prescription for renewable or non-renewable delivery;
▼M4	▼B
(a)	(b)
zdravila, ki se izdajajo na obnovljiv ali neobnovljiv zdravniški recept;	medicinal products subject to special medical prescription;
▼B	▼M4
(b)	(c)
zdravila, ki se izdajajo na poseben zdravniški recept;	medicinal products on ‘restricted’ medical prescription, reserved for use in certain specialised areas.
▼M4	▼B
(c)	Article 71
zdravila, ki se izdajajo na „omejen“; zdravniški recept in so namenjena izključno za uporabo na določenih specializiranih področjih.	1.
▼B	Medicinal products shall be subject to medical prescription where they:
Člen 71	—
1.	are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or
Zdravila so predmet zdravniškega recepta, kadar:	—
—	are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
bi verjetno lahko predstavljala neposredno ali posredno nevarnost tudi ob pravilni uporabi, če bi se uporabljala brez zdravniškega nadzora, ali	—
—	contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or
se pogosto in v veliki meri nepravilno uporabljajo, kar bi kot posledica verjetno lahko predstavljalo neposredno ali posredno nevarnost za človekovo zdravje, ali	—
—	are normally prescribed by a doctor to be administered parenterally.
vsebujejo snovi ali pripravke iz teh snovi, katerih delovanje in/ali neželene učinke je treba nadalje raziskati, ali	2.
—	Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors:
jih običajno predpisuje zdravnik in so namenjena parenteralni uporabi.	—
2.	the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force, such as the United Nations Conventions of 1961 and 1971, or
Kadar države članice določijo podskupine zdravil, ki so predmet zdravniškega recepta, upoštevajo naslednje dejavnike:	—
—	the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or
zdravilo vsebuje snov v količini, ki ni izvzeta iz posebnih določil konvencije in se uvršča med narkotične in psihotropne snovi v smislu mednarodno veljavnih konvencij, kot sta konvenciji Združenih narodov iz leta 1961 in 1971, ali	—
—	the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in the second indent as a precautionary measure.
zdravilo verjetno lahko ob nepravilni uporabi predstavlja precejšnje tveganje za medicinsko zlorabo, vodi do zasvojenosti ali zlorabe v nedovoljene namene, ali	3.
—	Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors:
zdravilo vsebuje snov, ki bi se zaradi svoje novosti ali lastnosti lahko obravnavala kot da sodi v skupino, predvideno v drugi alinei kot previdnostni ukrep.	—
3.	the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment,
Kadar države članice določijo podskupine zdravil, ki so namenjena izključno za uporabo na določenih specializiranih področjih, upoštevajo naslednje dejavnike:	—
—	the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or
zdravilo je, zaradi svojih farmacevtskih lastnosti ali novosti ali zaradi varovanja javnega zdravja, namenjeno za zdravljenja, ki jih je mogoče spremljati samo v bolnišničnem okolju,	—
—	the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment.
zdravilo se uporablja za zdravljenje stanj, ki jih je treba diagnosticirati v bolnišničnem okolju ali v institucijah z ustrezno diagnostično opremo, čeprav se dajanje zdravila in spremljanje lahko izvajata drugod, ali	4.
—	A competent authority may waive application of paragraphs 1, 2 and 3 having regard to:
zdravilo je namenjeno za ambulantne bolnike, toda njegova uporaba lahko povzroči zelo resne neželene učinke, kar zahteva recept zdravnika specialista in poseben nadzor med zdravljenjem.	(a)
4.	the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or
Pristojni organ lahko opusti uporabo odstavkov 1, 2 in 3 ob upoštevanju:	(b)
(a)	other circumstances of use which it has specified.
največjega enkratnega odmerka, največjega dnevnega odmerka, jakosti, farmacevtske oblike, nekaterih vrst pakiranja; in/ali	5.
(b)	If a competent authority does not designate medicinal products into sub-categories referred to in Article 70(2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine.
drugih okoliščin uporabe, ki jih podrobno navede.	Article 72
5.	Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 71.
Če pristojni organ zdravil ne razvrsti v podskupine iz člena 70(2), mora kljub temu pri odločanju upoštevati merila iz odstavkov 2 in 3 tega člena, ali zdravilo razvrstiti kot zdravilo, ki se izdaja le na recept.	Article 73
Člen 72	The competent authorities shall draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually.
Zdravila, ki niso predmet recepta, so tista zdravila, ki ne ustrezajo merilom iz člena 71.	▼M4
Člen 73	Article 74
Pristojni organi pripravijo seznam zdravil, ki se na njihovem ozemlju izdajajo le na recept in, če je potrebno, podrobno navedejo skupino razvrstitve. Seznam letno ažurirajo.	When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product by applying the criteria listed in Article 71.
▼M4	▼M4
Člen 74	Article 74a
Ko so pristojni organi obveščeni o novih dejstvih, preučijo, in če je potrebno, spremenijo razvrstitev zdravil ob upoštevanju meril iz člena 71.	Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.
▼M4	▼B
Člen 74a	Article 75
Kadar se sprememba razvrstitve zdravila odobri na podlagi pomembnih predkliničnih preskusov ali kliničnih preskušanj, se pristojni organ eno leto od odobritve prvotne spremembe ne sme sklicevati na rezultate teh preskusov ali preskušanj pri preučevanju vloge drugega predlagatelja ali imetnika dovoljenja za promet z zdravilom za spremembo razvrstitve iste učinkovine.	Each year, Member States shall communicate to the Commission and to the other Member States, the changes that have been made to the list referred to in Article 73.
▼B	TITLE VII
Člen 75	▼M11
Vsako leto države članice obvestijo Komisijo in druge države članic o spremembah seznama iz člena 73.	WHOLESALE DISTRIBUTION AND BROKERING OF MEDICINAL PRODUCTS
NASLOV VII	▼B
▼M11	Article 76
PROMET Z ZDRAVILI NA DEBELO IN POSREDOVANJE ZDRAVIL	►M4 1. ◄
▼B	Without prejudice to Article 6, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorization has been granted in accordance with Community law are distributed on their territory.
Člen 76	▼M4
►M4 1. ◄	2.
Brez poseganja v člen 6, države članice sprejmejo vse ustrezne ukrepe, da na svojem ozemlju zagotovijo distribucijo samo tistih zdravil, za katere je bilo izdano dovoljenje za promet v skladu z zakonodajo Skupnosti.	In the case of wholesale distribution and storage, medicinal products shall be covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
▼M4	▼M11
2.	3.
Za promet z zdravili na debelo in skladiščenje velja za zdravila dovoljenje za promet z zdravilom, izdano na podlagi Uredbe (ES) št. 726/2004 ali s strani pristojnih organov države članice v skladu s to direktivo.	Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product. In the case of medicinal products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State and to fees payable to the competent authority for examining the notification.
▼M11	4.
3.	In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed.
Vsak distributer, ki ni imetnik dovoljenja za promet z zdravilom, ki uvozi zdravilo iz druge države članice, o svoji nameri za uvoz zdravila uradno obvesti imetnika dovoljenja za promet in pristojni organ države članice, v katero se bo zdravilo uvozilo. V primeru zdravil, za katera ni bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, uradna obvestitev pristojnega organa ne posega v dodatne postopke iz zakonodaje te države članice, in v pristojbine, ki se plačajo pristojnim organom za preučitev uradnega obvestila.	▼B
4.	Article 77
V primeru zdravil, za katera je bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, distributer v skladu z odstavkom 3 tega člena imetniku dovoljenja in Agenciji predloži uradno obvestilo. Agenciji se plača pristojbina, da preveri, ali so upoštevani pogoji, določeni v zakonodaji Unije glede zdravil in dovoljenj za promet.	▼M11
▼B	1.
Člen 77	Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid.
▼M11	▼B
1.	2.
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da je promet z zdravili na debelo mogoč le na podlagi dovoljenja za promet z zdravilom, ki trgovcu na debelo omogoča opravljanje dejavnosti prometa z zdravili na debelo z navedbo prostorov na njihovem ozemlju, za katerega velja.	Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1.
▼B	3.
2.	Possession of a manufacturing authorization shall include authorization to distribute by wholesale the medicinal products covered by that authorization. Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.
Da se osebe, ki so po nacionalni zakonodaji pooblaščene za izdajo zdravil ali so jih upravičene izdajati širši javnosti, lahko vključijo v promet z zdravili na debelo, morajo pridobiti dovoljenje, predpisano v odstavku 1.	▼M11
3.	4.
Posedovanje dovoljenja za izdelavo zdravil vključuje dovoljenje za promet z zdravili na debelo, ki jih dovoljenje obsega. Posedovanje dovoljenja za opravljanje dejavnosti trgovca na debelo na področju zdravil ne daje oprostitve obveznosti posedovanja dovoljenja za proizvodnjo ter obveznosti prilagajanja za to določenim pogojem, četudi sta proizvodnja ali uvoz sekundarna.	Member States shall enter the information relating to the authorisations referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6). At the request of the Commission or any Member State, Member States shall provide all appropriate information concerning the individual authorisations which they have granted under paragraph 1 of this Article.
▼M11	5.
4.	Checks on the persons authorised to engage in activity as a wholesaler in medicinal products, and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorisation for premises located on its territory.
Države članice informacije o dovoljenju iz odstavka 1 tega člena vnesejo v podatkovno bazo Unije iz člena 111(6). Države članice na zahtevo Komisije ali katere koli države članice zagotovijo vse ustrezne informacije o posameznih dovoljenjih, ki so jih izdale v skladu z odstavkom 1 tega člena.	▼B
5.	6.
Preverjanja oseb, ki so pooblaščene za opravljanje dejavnosti prometa z zdravili na debelo, ter inšpekcijski pregled njihovih prostorov potekajo pod odgovornostjo države članice, ki je izdala dovoljenje za prostore na njenem ozemlju.	The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met. It shall forthwith inform the other Member States and the Commission thereof.
▼B	7.
6.	Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer met, it shall forthwith inform the Commission and the other Member State involved. The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions.
Država članica, ki je izdala dovoljenje iz odstavka 1, dovoljenje začasno prekliče ali ukine, če niso izpolnjeni pogoji dovoljenja. Država članica o tem takoj obvesti ostale države članice in Komisijo.	Article 78
7.	Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.
Če država članica meni, da oseba, ki ima dovoljenje, ki ga je izdala druga država članica po pogojih odstavka 1, pogojev dovoljenja ne izpolnjuje, ali ne izpolnjuje več, o tem takoj obvesti Komisijo in vpleteno državo članico. Ta sprejme potrebne ukrepe in obvesti Komisijo in prvo državo članico o sprejetih odločitvah ter razlogih zanje.	The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.
Člen 78	Article 79
Države članice zagotovijo, da čas postopka za preučitev vloge za dovoljenje za promet z zdravili na debelo ne preseže 90 dni od dneva, ko pristojni organ zadevne države članice prejme vlogo.	In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:
Če je potrebno, pristojni organ od vlagatelja lahko zahteva, da predloži vse potrebne informacije glede pogojev dovoljenja. Če organ uporabi to možnost, rok, ki ga določa prvi odstavek, preneha teči do predložitve zahtevanih dodatnih informacij.	(a)
Člen 79	they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;
Za pridobitev dovoljenja za promet z zdravili na debelo morajo vlagatelji izpolnjevati naslednje minimalne zahteve:	(b)
(a)	they must have staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned;
imeti morajo ustrezne in primerne prostore, instalacije in opremo, tako da zagotovijo ustrezno shranjevanje in distribucijo zdravil;	(c)
(b)	they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.
imeti morajo osebje in zlasti usposobljeno osebo, ki je uradno imenovana kot odgovorna in izpolnjuje pogoje, predpisane z zakonodajo zadevne države članice;	Article 80
(c)	Holders of the distribution authorization must fulfil the following minimum requirements:
zagotavljati morajo izpolnjevanje pogojev, ki so njihova dolžnost po določbah člena 80.	(a)
Člen 80	they must make the premises, installations and equipment referred to in Article 79(a) accessible at all times to the persons responsible for inspecting them;
Imetniki dovoljenja za promet z zdravili na debelo morajo izpolnjevati naslednje minimalne pogoje:	(b)
(a)	they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorization or who are exempt from obtaining such authorization under the terms of Article 77(3);
prostori, instalacije in oprema iz člena 79(a) morajo biti vedno dostopni osebam, odgovornim za inšpekcijski pregled;	(c)
(b)	they must supply medicinal products only to persons who are themselves in possession of the distribution authorization or who are authorized or entitled to supply medicinal products to the public in the Member State concerned;
z zdravili se smejo oskrbovati samo pri osebah, ki so tudi same imetniki dovoljenja za promet z zdravili na debelo ali pa jim v skladu z določbami člena 77(3) takega dovoljenja ni treba pridobiti;	▼M11
(c)	(ca)
zdravila smejo izdajati samo osebam, ki imajo tudi dovoljenje za promet z zdravili na debelo, ki imajo v zadevni državi članici uradno dovoljenje za izdajanje ali imajo pravico izdajati zdravila širši javnosti;	they must verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts referred to in Article 54a(2);
▼M11	▼B
(ca)	(d)
s preverjanjem zaščitnih elementov na zunanji ovojnini v skladu z zahtevami iz delegiranih aktov, navedenih v členu 54a(2), morajo preveriti, da zdravila, ki so jih dobili, niso ponarejena;	they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned;
▼B	▼M11
(d)	(e)
imeti morajo načrt ukrepov ob izrednih dogodkih, ki zagotavlja učinkovito izvajanje vsakega odpoklica zdravila iz prometa, ki ga odredi pristojni organ ali ga izvede v sodelovanju s proizvajalcem zdravila ali z imetnikom dovoljenja za promet z zadevnim zdravilom;	they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or brokered at least the following information:
▼M11	—
(e)	date,
voditi morajo dokumentacijo v obliki nabavnih/prodajnih računov, na računalniku ali v kateri koli drugi obliki, ki vsebuje vsaj naslednje informacije o vsakem poslu, pri katerem se zdravila prejmejo, odpošljejo ali posredujejo:	—
—	name of the medicinal product,
datum,	—
—	quantity received, supplied or brokered,
ime zdravila,	—
—	name and address of the supplier or consignee, as appropriate,
količina, ki je bila prejeta, dobavljena ali posredovana,	—
—	batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;
ime in naslov dobavitelja ali prejemnika, kot je primerno,	▼B
—	(f)
serijska številka zdravila vsaj za zdravila, ki nosijo zaščitne elemente, kot je določeno v točki (o) člena 54;	they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years;
▼B	(g)
(f)	they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84;
dokumentacijo, navedeno pod (e), ki mora biti na voljo pristojnim organom za inšpekcijski pregled, morajo hraniti za obdobje petih let;	▼M11
(g)	(h)
ravnati morajo v skladu z načeli in smernicami dobre distribucijske prakse za zdravila, kot jih določa člen 84;	they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities;
▼M11	(i)
(h)	they must immediately inform the competent authority and, where applicable, the marketing authorisation holder, of medicinal products they receive or are offered which they identify as falsified or suspect to be falsified.
vzdrževati morajo sistem kakovosti, ki določa odgovornosti, postopke in ukrepe obvladovanja tveganja v zvezi z njihovimi dejavnostmi;	For the purposes of point (b), where the medicinal product is obtained from another wholesale distributor, wholesale distribution authorisation holders must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation.
(i)	Where the medicinal product is obtained from the manufacturer or importer, wholesale distribution authorisation holders must verify that the manufacturer or importer holds a manufacturing authorisation.
nemudoma morajo pristojni organ in po potrebi imetnika dovoljenja za promet obvestiti o zdravilih, ki jih prejmejo ali jim jih ponudijo in za katera ugotovijo ali sumijo, da so ponarejena.	Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holders must verify that the broker involved fulfils the requirements set out in this Directive.
Za namene točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem trgovcu na debelo, preveriti skladnost z načeli in smernicami dobrih distribucijskih praks dobavitelja trgovca na debelo. To vključuje preverjanje, ali ima dobavitelj trgovca na debelo dovoljenje za promet na debelo.	▼M4
Kadar se zdravilo pridobi pri proizvajalcu ali uvozniku, morajo imetniki dovoljenja za promet na debelo preveriti, ali ima proizvajalec ali uvoznik dovoljenje za proizvodnjo.	Article 81
Kadar se zdravila pridobijo s posredovanjem, morajo imetniki dovoljenja za promet na debelo preveriti, da udeleženi posrednik izpolnjuje zahteve iz te direktive.	With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.
▼M4	The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Člen 81	The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.
V zvezi z dobavo zdravil farmacevtom in osebam, ki imajo dovoljenje za izdajo ali smejo izdajati zdravila širši javnosti, države članice imetniku dovoljenja za promet z zdravili na debelo, ki mu ga je izdala druga država članica, ne nalagajo nobenih obveznosti, zlasti obveznosti javnih storitev, ki bi bile strožje od obveznosti, naloženih osebam, katerim so same izdale dovoljenje za opravljanje enakovrednih dejavnosti.	▼B
Imetnik dovoljenja za promet z zdravilom in distributerji omenjenega zdravila, ki je dejansko na trgu v državi članici, v okviru svojih pristojnosti zagotovijo ustrezno in neprekinjeno dobavo tega zdravila farmacevtom in osebam, ki imajo dovoljenje za prodajo zdravil, tako da so pokrite potrebe bolnikov v zadevni državi članici. Načini izvajanja tega člena morajo biti utemeljeni, predvsem z varovanjem javnega zdravja, biti v sorazmerju s ciljem takega varovanja, in v skladu z določbami Pogodbe, zlasti z določbami glede prostega pretoka blaga in konkurence.	Article 82
▼B	For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain:
Člen 82	—
K vsem dobavam zdravil osebi, ki ima dovoljenje ali pravico izdajati zdravila javnosti v zadevni državi članici, mora pooblaščeni trgovec na debelo priložiti dokument, na podlagi katerega je možno ugotoviti:	the date,
—	▼M4
datum,	—
▼M4	the name and pharmaceutical form of the medicinal product,
—	▼B
ime in farmacevtsko obliko zdravila,	—
▼B	the quantity supplied,
—	—
dobavljeno količino,	the name and address of the supplier and consignor,
—	▼M11
ime in naslov dobavitelja in pošiljatelja,	—
▼M11	batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54.
—	▼B
serijska številka zdravila vsaj za zdravila, ki nosijo zaščitne elemente, kot je določeno v točki (o) člena 54.	Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.
▼B	Article 83
Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da so osebe, ki so pooblaščene za izdajanje ali imajo pravico izdajati zdravila širši javnosti, sposobne predložiti informacije, ki omogočajo sledljivost distribucijske poti vsakega zdravila.	The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:
Člen 83	—
Določbe tega naslova ne smejo preprečiti uporabe strožjih zahtev, ki jih države članice določijo v zvezi s prometom na debelo za:	narcotic or psychotropic substances within their territory,
—	—
narkotične ali psihotropne snovi na svojem ozemlju,	medicinal products derived from blood,
—	—
zdravila, pridobljena iz krvi,	immunological medicinal products,
—	—
imunološka zdravila,	radiopharmaceuticals.
—	▼M4
radiofarmacevtske izdelke.	Article 84
▼M4	The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC ( 11 ).
Člen 84	Article 85
Komisija objavi smernice dobre distribucijske prakse. V ta namen se posvetuje z Odborom za zdravila za uporabo v humani medicini in Farmacevtskim odborom, ustanovljenim s Sklepom Sveta 75/320/EGS ( 11 ).	This Title shall apply to homeopathic medicinal products.
Člen 85	▼M12
Ta naslov se uporablja za homeopatska zdravila.	Article 85a
▼M12	In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of the first paragraph of Article 80 shall not apply. Moreover, points (b) and (ca) of the first paragraph of Article 80 shall not apply where a product is directly received from a third country but not imported. However, in that case wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned. Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned. The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.
Člen 85a	▼M11
Za promet z zdravili na debelo v tretje države se ne uporabljata člen 76 in točka (c) prvega odstavka člena 80. Poleg tega se ne uporabljata točki (b) in (ca) prvega odstavka člena 80, kadar se izdelek prejme neposredno iz tretje države, vendar se ne uvozi. Vendar v tem primeru trgovci na debelo zagotovijo, da zdravila pridobijo samo od oseb, ki imajo dovoljenje ali so pooblaščene za dobavljanje zdravil v skladu z veljavnimi pravnimi in upravnimi določbami zadevne tretje države. Če trgovci na debelo zdravila dobavljajo osebam tretjih držav, zagotovijo, da jih dobavljajo samo osebam, ki imajo dovoljenje ali so pooblaščene za prejemanje zdravil za namen prodaje na debelo ali izdajanja zdravil javnosti v skladu z veljavnimi pravnimi in upravnimi določbami zadevne tretje države. Zahteve iz člena 82 se uporabljajo za dobavo zdravil osebam v tretjih državah, ki imajo dovoljenje ali pravico do izdajanja zdravil javnosti.	Article 85b
▼M11	1.
Člen 85b	Persons brokering medicinal products shall ensure that the brokered medicinal products are covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
1.	Persons brokering medicinal products shall have a permanent address and contact details in the Union, so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities.
Osebe, ki posredujejo zdravila, zagotovijo, da so zdravila, ki jih posredujejo, vključena v dovoljenje za promet, ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 ali so ga izdali pristojni organi države članice v skladu s to direktivo.	The requirements set out in points (d) to (i) of Article 80 shall apply mutatis mutandis to the brokering of medicinal products.
Osebe, ki posredujejo zdravila, imajo stalni naslov in kontaktne podatke v Uniji, zato da lahko pristojni organi ustrezno identificirajo, umestijo, sporočajo in nadzirajo njihove dejavnosti.	2.
Zahteve iz točk (d) do (i) člena 80 se smiselno uporabljajo za posredovanje zdravil.	Persons may only broker medicinal products if they are registered with the competent authority of the Member State of their permanent address referred to in paragraph 1. Those persons shall submit, at least, their name, corporate name and permanent address in order to register. They shall notify the competent authority of any changes thereof without unnecessary delay.
2.	Persons brokering medicinal products who had commenced their activity before 2 January 2013 shall register with the competent authority by 2 March 2013.
Osebe lahko zdravila posredujejo le, če imajo stalni naslov iz odstavka 1 registriran pri pristojnem organu države članice. Za registracijo morajo te osebe predložiti vsaj svoje ime, naziv podjetja in stalni naslov. Če se navedeno spremeni, o tem brez nepotrebnega odlašanja obvestijo pristojni organ.	The competent authority shall enter the information referred to in the first subparagraph in a register that shall be publicly accessible.
Osebe, ki posredujejo zdravila in so začele svojo dejavnost pred 2. januarjem 2013, se pri pristojnem organu registrirajo do 2. marca 2013.	3.
Pristojni organ vnese informacije iz prvega pododstavka v javno dostopen register.	The guidelines referred to in Article 84 shall include specific provisions for brokering.
3.	4.
Smernice iz člena 84 vključujejo posebne določbe za posredovanje.	This Article shall be without prejudice to Article 111. Inspections referred to in Article 111 shall be carried out under the responsibility of the Member State where the person brokering medicinal products is registered.
4.	If a person brokering medicinal products does not comply with the requirements set out in this Article, the competent authority may decide to remove that person from the register referred to in paragraph 2. The competent authority shall notify that person thereof.
Ta člen ne posega v člen 111. Za opravljanje inšpekcijskih pregledov iz člena 111 je pristojna država članica, v kateri je registrirana oseba, ki posreduje zdravila.	TITLE VIIA
Če oseba, ki posreduje zdravila, ne izpolnjuje zahtev iz tega člena, lahko pristojni organ odloči, da se ta oseba izbriše iz registra iz odstavka 2. Pristojni organ to osebo obvesti o svoji odločitvi.	SALE AT A DISTANCE TO THE PUBLIC
NASLOV VIIA	Article 85c
PRODAJA JAVNOSTI NA DALJAVO	1.
Člen 85c	Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services ( 12 ) under the following conditions:
1.	(a)
Brez poseganja v nacionalno zakonodajo, ki prepoveduje ponujanje zdravil na recept v prodajo javnosti na daljavo prek storitev informacijske družbe, države članice zagotovijo, da se zdravila ponudijo v prodajo javnosti na daljavo prek storitev informacijske družbe, kakor določa Direktiva 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov o storitvah informacijske družbe ( 12 ), pod naslednjimi pogoji:	the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established;
(a)	(b)
fizična ali pravna oseba, ki ponuja zdravila, ima v skladu z nacionalno zakonodajo države članice, v kateri ima sedež, dovoljenje ali pravico za izdajanje zdravil javnosti tudi na daljavo;	the person referred to in point (a) has notified the Member State in which that person is established of at least the following information:
(b)	(i)
oseba iz točke (a) je državo članico, v kateri ima sedež, uradno obvestila vsaj o naslednjih informacijah:	name or corporate name and permanent address of the place of activity from where those medicinal products are supplied;
(i)	(ii)
imenu ali nazivu podjetja ter stalnem naslovu kraja dejavnosti, od koder se zdravila dobavljajo;	the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services;
(ii)	(iii)
datumu začetka dejavnosti ponujanja zdravil v prodajo javnosti na daljavo prek storitev informacijske družbe;	the address of the website used for that purpose and all relevant information necessary to identify that website;
(iii)	(iv)
naslovu spletnega mesta, ki se uporablja v ta namen, in vseh drugih zadevnih informacijah, ki so potrebne za identifikacijo tega spletnega mesta;	if applicable, the classification in accordance with Title VI of the medicinal products offered for sale at a distance to the public by means of information society services.
(iv)	Where appropriate, that information shall be updated;
po potrebi o razvrstitvi zdravil, ki se ponudijo v prodajo javnosti na daljavo prek storitev informacijske družbe, v skladu z naslovom VI.	(c)
Te informacije se po potrebi posodobijo;	the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 6(1);
(c)	(d)
zdravila so skladna z nacionalno zakonodajo namembne države članice v skladu s členom 6(1);	without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) ( 13 ), the website offering the medicinal products contains at least:
(d)	(i)
brez poseganja v informacijske zahteve iz Direktive 2000/31/ES Evropskega parlamenta in Sveta z dne 8. junija 2000 o nekaterih pravnih vidikih storitev informacijske družbe, zlasti elektronskega poslovanja na notranjem trgu (Direktiva o elektronskem poslovanju) ( 13 ), spletno mesto, ki ponuja zdravila, vsebuje vsaj:	the contact details of the competent authority or the authority notified pursuant to point (b);
(i)	(ii)
kontaktne podatke pristojnega organa ali organa, uradno obveščenega v skladu s točko (b);	a hyperlink to the website referred to in paragraph 4 of the Member State of establishment;
(ii)	(iii)
hiperpovezavo do spletnega mesta iz odstavka 4 države članice sedeža;	the common logo referred to in paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of medicinal products. The common logo shall contain a hyperlink to the entry of the person in the list referred to in point (c) of paragraph 4.
(iii)	2.
skupni logotip iz odstavka 3, ki je jasno objavljen na vseh straneh spletnega mesta, povezanega s ponudbo zdravil v prodajo javnosti na daljavo. Skupni logotip ima hiperpovezavo na vnos osebe na seznamu iz točke (c) odstavka 4.	Member States may impose conditions, justified on grounds of public health protection, for the retail supply on their territory of medicinal products for sale at a distance to the public by means of information society services.
2.	3.
Države članice lahko postavijo pogoje, utemeljene iz razlogov varovanja javnega zdravja, za prodajo na drobno zdravil za prodajo javnosti na daljavo prek storitev informacijske družbe na svojem ozemlju.	A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering medicinal products for sale at a distance to the public is established. That logo shall be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with point (d) of paragraph 1.
3.	In order to harmonise the functioning of the common logo, the Commission shall adopt implementing acts regarding:
Oblikuje se skupni logotip, ki je prepoznaven po vsej Uniji, in ki hkrati omogoči prepoznavo države članice, v kateri ima sedež oseba, ki ponuja zdravila v prodajo javnosti na daljavo. Logotip je vidno prikazan na spletnih mestih, ki ponujajo zdravila v prodajo javnosti na daljavo v skladu s točko (d) odstavka 1.	(a)
Komisija za uskladitev uporabe tega skupnega logotipa sprejme izvedbene akte glede:	the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;
(a)	(b)
tehničnih, elektronskih in kriptografskih zahtev za preverjanje avtentičnosti skupnega logotipa;	the design of the common logo.
(b)	Those implementing acts shall, where necessary, be amended to take account of technical and scientific progress. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).
zasnove skupnega logotipa.	4.
Ti izvedbeni akti se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek. Ti izvedbeni akti se sprejmejo v skladu s postopkom iz člena 121(2).	Each Member State shall set up a website providing at least the following:
4.	(a)
Vsaka država članica oblikuje spletno mesto, ki zagotavlja vsaj:	information on the national legislation applicable to the offering of medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding classification of medicinal products and the conditions for their supply;
(a)	(b)
informacije o nacionalni zakonodaji, ki se uporablja za ponujanje zdravil v prodajo javnosti na daljavo prek storitev informacijske družbe, vključno z informacijami o tem, da utegne priti med državami članicami do razlik pri razvrščanju zdravil in pogojih za njihovo dobavo;	information on the purpose of the common logo;
(b)	(c)
informacije za namene skupnega logotipa;	the list of persons offering the medicinal products for sale at a distance to the public by means of information society services in accordance with paragraph 1 as well as their website addresses;
(c)	(d)
seznam oseb, ki ponujajo zdravila v prodajo javnosti na daljavo prek storitev informacijske družbe v skladu z odstavkom 1, in naslove njihovih spletnih mest;	background information on the risks related to medicinal products supplied illegally to the public by means of information society services.
(d)	This website shall contain a hyperlink to the website referred to in paragraph 5.
osnovne informacije o tveganjih, povezanih z zdravili, ki se javnosti nezakonito izdajajo prek storitev informacijske družbe.	5.
To spletno mesto vsebuje tudi hiperpovezavo do spletnega mesta iz odstavka 5.	The Agency shall set up a website providing the information referred to in points (b) and (d) of paragraph 4, information on the Union legislation applicable to falsified medicinal products as well as hyperlinks to the Member States’ websites referred to in paragraph 4. The Agency’s website shall explicitly mention that the Member States’ websites contain information on persons authorised or entitled to supply medicinal products at a distance to the public by means of information society services in the Member State concerned.
5.	6.
Agencija vzpostavi spletno mesto, ki zagotavlja informacije iz točk (b) in (d) odstavka 4, informacije o veljavni zakonodaji Unije o ponarejenih zdravilih in hiperpovezave do spletnih mest držav članic iz odstavka 4. Na spletnem mestu Agencije je izrecno zapisano, da spletna mesta držav članic vsebujejo informacije o osebah, ki imajo dovoljenje ali pravico, da javnosti izdajajo zdravila na daljavo prek storitev informacijske družbe v zadevni državi članici.	Without prejudice to Directive 2000/31/EC and the requirements set out in this Title, Member States shall take the necessary measures to ensure that other persons than those referred to in paragraph 1 that offer medicinal products for sale at a distance to the public by means of information society services and that operate on their territory are subject to effective, proportionate and dissuasive penalties.
6.	Article 85d
Brez poseganja v Direktivo 2000/31/ES in v zahteve, opredeljene v tem naslovu, države članice sprejmejo potrebne ukrepe, s katerimi zagotovijo, da za osebe, ki niso navedene v odstavku 1 in javnosti ponujajo v prodajo zdravila na daljavo prek storitev informacijske družbe ter poslujejo na njihovih ozemljih, veljajo učinkovite, sorazmerne in odvračilne kazni.	Without prejudice to the competences of the Member States, the Commission shall, in cooperation with the Agency and Member State authorities, conduct or promote information campaigns aimed at the general public on the dangers of falsified medicinal products. Those campaigns shall raise consumer awareness of the risks related to medicinal products supplied illegally at a distance to the public by means of information society services and of the functioning of the common logo, the Member States’ websites and the Agency’s website.
Člen 85d	▼B
Brez poseganja v pristojnosti držav članic Komisija v sodelovanju z Agencijo in organi držav članic izvede ali spodbudi splošni javnosti namenjene informacijske kampanje o tveganjih, povezanih s ponarejenimi zdravili. Te kampanje ozaveščajo potrošnike o tveganjih, povezanih z zdravili, ki se javnosti nezakonito izdajajo na daljavo prek storitev informacijske družbe, ter o vlogi skupnega logotipa, spletnih mest držav članic in spletnem mestu Agencije.	TITLE VIII
▼B	ADVERTISING
NASLOV VIII	Article 86
OGLAŠEVANJE	1.
Člen 86	For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:
1.	—
Za namen tega naslova izraz „oglaševanje zdravil“ vključuje vse oblike obveščanja, vključno z obveščanjem od vrat do vrat, agitiranjem ali spodbujanjem z namenom, da se spodbuja predpisovanje, izdajanje, prodaja ali potrošnja zdravil; vključuje zlasti:	the advertising of medicinal products to the general public,
—	—
oglaševanje zdravil širši javnosti,	advertising of medicinal products to persons qualified to prescribe or supply them,
—	—
oglaševanje zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil,	visits by medical sales representatives to persons qualified to prescribe medicinal products,
—	—
obiske strokovnih sodelavcev za prodajo zdravil pri osebah, usposobljenih za predpisovanje zdravil,	the supply of samples,
—	—
dajanje vzorcev,	the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
—	—
določila glede spodbujanja k predpisovanju ali izdajanju zdravil z darili, ponujanjem ali obljubljanjem koristi ali premij, v denarju ali v naravi, razen če je dejanska vrednost daril majhna,	sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,
—	—
sponzoriranje promocijskih srečanj, ki jih obiskujejo osebe, usposobljene za predpisovanje ali izdajanje zdravil,	sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
—	2.
sponzoriranje znanstvenih kongresov, ki se jih udeležujejo osebe, usposobljene za predpisovanje ali izdajanje zdravil, zlasti v obliki plačila stroškov njihovih potovanj in bivanja s tem v zvezi.	The following are not covered by this Title:
2.	—
Naslov ne vključuje:	the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,
—	—
označevanja in priloženega navodila za uporabo, kar urejajo določbe naslova V,	correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product,
—	—
dopisovanja, po možnosti s priloženimi gradivi, ki niso promocijske narave in so potrebna kot odgovor na specifična vprašanja o določenem zdravilu,	factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims,
—	▼M4
informativnih objav o dejstvih ter referenčna gradiva, na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnih katalogov in cenikov, ki ne vključujejo navedb o lastnostih zdravila,	—
▼M4	information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.
—	▼B
informacije v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega ne, na zdravila.	Article 87
▼B	1.
Člen 87	Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.
1.	2.
Države članice prepovejo vsakršno oglaševanje zdravila, za katerega dovoljenje za promet ni bilo pridobljeno v skladu z zakonodajo Skupnosti.	All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.
2.	3.
Vsi elementi oglaševanja zdravila morajo biti v skladu s podrobnimi podatki, navedenimi v povzetku glavnih značilnostih zdravila.	The advertising of a medicinal product:
3.	—
Oglaševanje zdravila:	shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
—	—
spodbuja smotrno uporabo zdravila, s tem da zdravilo predstavlja objektivno in brez pretiravanja o njegovih lastnostih,	shall not be misleading.
—	▼M4
ni zavajajoče.	Article 88
▼M4	1.
Člen 88	Member States shall prohibit the advertising to the general public of medicinal products which:
1.	(a)
Države članice prepovejo oglaševanje širši javnosti zdravil, ki:	are available on medical prescription only, in accordance with Title VI;
(a)	(b)
se izdajajo le na recept, v skladu z naslovom VI;	contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971.
(b)	2.
vsebujejo psihotropne ali narkotične snovi, kot so navedene v mednarodnih konvencijah, kot sta konvenciji Združenih narodov iz leta 1961 in 1971.	Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
2.	3.
Širši javnosti je dovoljeno oglaševati zdravila, ki so zaradi svoje sestave in namena, namenjena in oblikovana za uporabo brez posredovanja zdravnika za diagnostične namene ali za predpisovanje ali spremljanje zdravljenja, po nasvetu farmacevta, če je to potrebno.	Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.
3.	4.
Države članice lahko na svojem ozemlju prepovejo oglaševanje zdravil širši javnosti, za katere je možno nadomestilo stroškov.	The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
4.	5.
Prepoved iz odstavka 1 se ne uporablja v primeru kampanj za cepljenje, ki ga izvaja industrija in ga odobrijo pristojni organi držav članic.	The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC.
5.	6.
Prepoved iz odstavka 1 se uporablja brez vpliva na člen 14 Direktive 89/552/EGS.	Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes.
6.	▼M4
Države članice prepovejo neposredno razdeljevanje zdravil javnosti s strani industrije v promocijske namene.	TITLE VIIIa
▼M4	INFORMATION AND ADVERTISING
NASLOV VIIIa	Article 88a
OBVEŠČANJE IN OGLAŠEVANJE	Within three years of the entry into force of Directive 2004/726/EC, the Commission shall, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision — particularly on the Internet — and its risks and benefits for patients.
Člen 88a	Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability.
V treh letih po začetku veljavnosti Uredbe 2004/726/ES Komisija po posvetovanju z organizacijami bolnikov in potrošnikov, organizacijami zdravnikov in farmacevtov, državami članicami in drugimi zainteresiranimi strankami Evropskemu parlamentu in Svetu predloži poročilo o obstoječi praksi glede zagotavljanja informacij – predvsem prek interneta – ter o tveganjih in koristih za bolnike.	▼B
Po analizi zgornjih podatkov Komisija, če je to primerno, da predloge o strategiji obveščanja za zagotavljanje kakovostnih, objektivnih, zanesljivih in nepromocijskih informacij o zdravilih ter drugih oblikah zdravljenja ter stališče do vprašanja odgovornosti virov informacij.	Article 89
▼B	1.
Člen 89	Without prejudice to Article 88, all advertising to the general public of a medicinal product shall:
1.	(a)
Brez poseganja v člen 88, se celotno oglaševanje širši javnosti zdravila:	be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product;
(a)	(b)
pripravi tako, da je jasno, da gre za reklamno sporočilo ter, da je izdelek jasno predstavljen kot zdravilo;	include the following minimum information:
(b)	—
da vključuje najmanj naslednje podatke:	the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance,
—	—
ime zdravila, kot tudi splošno ime, če zdravilo vsebuje samo eno zdravilno učinkovino,	the information necessary for correct use of the medicinal product,
—	—
informacije, potrebne za pravilno uporabo zdravila,	an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be.
—	▼M4
jasno čitljivo povabilo uporabniku, da natančno prebere navodila na navodilu za uporabo ali na zunanji ovojnini, odvisno od primera.	2.
▼M4	Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product or its international non-proprietary name, where this exists, or the trademark if it is intended solely as a reminder.
2.	▼B
Države članice se lahko odločijo, da oglaševanje zdravila širši javnosti lahko, ne glede na odstavek 1, vključuje samo ime zdravila ali njegovo mednarodno nelastniško ime, če to obstaja, ali blagovno znamko, če služi izključno kot opomnik.	Article 90
▼B	The advertising of a medicinal product to the general public shall not contain any material which:
Člen 90	(a)
Oglaševanje zdravila širši javnosti ne sme vsebovati podatkov, ki:	gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
(a)	(b)
dajejo vtis, da sta posvet z zdravnikom ali kirurški poseg nepotrebna, zlasti z nudenjem diagnoze ali predlogom zdravljenja po pošti;	suggests that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
(b)	(c)
nakazujejo, da so učinki jemanja zdravila zagotovljeni, da ni neželenih učinkov ali da je boljše kot ali enakovredno drugemu zdravljenju ali drugemu zdravilu;	suggests that the health of the subject can be enhanced by taking the medicine;
(c)	(d)
nakazujejo, da se zdravje osebe lahko izboljša z jemanjem zdravila;	suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to the vaccination campaigns referred to in Article 88(4);
(d)	(e)
nakazujejo, da bi zdravje osebe lahko bilo prizadeto brez jemanja zdravila; ta prepoved se ne uporablja za kampanje o cepljenju iz člena 88(4);	is directed exclusively or principally at children;
(e)	(f)
je usmerjen izključno ali pretežno k otrokom;	refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
(f)	(g)
se sklicuje na priporočila znanstvenikov, zdravstvenih strokovnjakov ali oseb, ki niso ne eno ne drugo, pa bi zaradi svoje slave lahko spodbujali potrošnjo zdravil;	suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
(g)	(h)
nakazujejo, da je zdravilo živilo, kozmetični ali drug potrošniški izdelek;	suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
(h)	(i)
nakazujejo, da se varnost in učinkovitost zdravila pripisuje dejstvu, da je naravnega izvora;	could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
(i)	(j)
bi zaradi opisa ali podrobne predstavitve anamneze lahko privedel do napačne samodiagnoze;	refers, in improper, alarming or misleading terms, to claims of recovery;
(j)	(k)
ob uporabi neprimernih, vznemirljivih ali zavajajočih izrazov o možnostih okrevanja;	uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof.
(k)	▼M4 —————
uporablja neprimerne, vznemirljive ali zavajajoče izraze, slikovne predstavitve sprememb v človeškem telesu, ki jih je povzročila bolezen ali poškodba, ali delovanje zdravila na človeško telo ali dele telesa.	▼B
▼M4 —————	Article 91
▼B	1.
Člen 91	Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include:
1.	—
Oglaševanje zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil, vsebuje:	essential information compatible with the summary of product characteristics;
—	—
osnovne informacije v skladu s povzetkom glavnih značilnosti zdravila,	the supply classification of the medicinal product.
—	Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies.
razvrstitev zdravila glede na izdajanje.	▼M4
Države članice lahko tudi zahtevajo, da oglaševanje zdravila osebam, usposobljenim za predpisovanje ali izdajanje zdravila, vključuje prodajno ceno ali okvirno ceno za različne oblike pakiranja ter pogoje za nadomestilo stroškov s strani organov socialnega varstva.	2.
▼M4	Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder.
2.	▼B
Države članice se lahko odločijo, da oglaševanje zdravila osebam, usposobljenim za predpisovanje in izdajanje zdravila, ne glede na odstavek 1, vključuje samo ime zdravila, ali njegovo mednarodno nelastniško ime, če to obstaja, ali blagovno znamko, če služi izključno kot opomnik.	Article 92
▼B	1.
Člen 92	Any documentation relating to a medicinal product which is transmitted as part of the promotion of that product to persons qualified to prescribe or supply it shall include, as a minimum, the particulars listed in Article 91(1) and shall state the date on which it was drawn up or last revised.
1.	2.
Dokumentacija v zvezi zdravilom, ki se kot del njegove promocije pošilja osebam, usposobljenim za predpisovanje ali izdajanje zdravil, vsebuje najmanj podatke iz člena 91(1) in navaja datum, ko je bila pripravljena ali nazadnje revidirana.	All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned.
2.	3.
Vse informacije v dokumentaciji iz odstavka 1, morajo biti točne, usklajene z zadnjim stanjem, preverljive in dovolj popolne, da prejemniku omogočijo, da si ustvari lastno mnenje o terapevtski vrednosti zadevnega zdravila.	Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated.
3.	Article 93
Navedbe in preglednice ter ostalo slikovno gradivo iz medicinskih revij ali drugih znanstvenih del se v dokumentaciji iz odstavka 1 verodostojno povzame s točno navedbo virov.	1.
Člen 93	Medical sales representatives shall be given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicinal products which they promote.
1.	2.
Podjetje, ki zaposluje strokovne sodelavce za prodajo zdravil, jim mora omogočati ustrezno usposabljanje; imeti morajo dovolj strokovnega znanja, da lahko posredujejo informacije, ki so v največji možni meri natančni in popolni podatki o zdravilu, ki je predmet njihove promocije.	During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement referred to in Article 91(1).
2.	3.
Ob vsakem obisku strokovni sodelavci za prodajo zdravil obiskanim osebam posredujejo ali jim dajo na voljo povzetke glavnih značilnosti zdravila za vsako predstavljeno zdravilo, skupaj s podrobnostmi o ceni in pogojih za nadomestilo plačila, navedenega v členu 91(1), če zakonodaja države članice to dovoljuje.	Medical sales representatives shall transmit to the scientific service referred to in Article 98(1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit.
3.	Article 94
Strokovni službi, navedeni v členu 98(1), strokovni sodelavci za prodajo zdravil prenesejo vse informacije o uporabi zdravil, ki jih oglašujejo, s posebno navedbo kakršnih koli neželenih učinkov, o katerih so jim poročale obiskane osebe.	1.
Člen 94	Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.
1.	▼M4
Pri promocijah zdravil se ne sme dajati, ponujati ali obljubljati daril, denarnih ugodnosti ali nuditi materialne koristi osebam, usposobljenim za predpisovanje ali izdajanje zdravil, razen če so ti majhne vrednosti in se lahko uporabljajo za opravljanje zdravstvene ali lekarniške dejavnosti.	2.
▼M4	Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than health-care professionals.
2.	▼B
Gostoljubnost med promocijskimi srečanji mora biti vedno strogo omejena na glavni namen srečanja, deležni pa je smejo biti samo zdravstveni delavci.	3.
▼B	Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2.
3.	4.
Osebe, usposobljene za predpisovanje ali izdajanje zdravil, se ne smejo potegovati za ali sprejemati kakršnih koli materialnih spodbud, ki so prepovedane na podlagi odstavka 1 ali so v nasprotju z odstavkom 2.	Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by paragraphs 1, 2 and 3.
4.	▼M4
Odstavki 1, 2 in 3 ne vplivajo na obstoječe ukrepe ali poslovno prakso držav članic v zvezi s cenami, maržami ali popusti.	Article 95
▼M4	The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals.
Člen 95	▼B
Določbe člena 94(1) ne preprečujejo gostoljubnosti, neposredne ali posredne, ob dogodkih, katerih cilji so v celoti strokovni ali znanstveni; ponujeno gostoljubje mora biti vedno strogo omejeno na glavni znanstveni cilj srečanja; deležni so ga lahko samo zdravstveni delavci.	Article 96
▼B	1.
Člen 96	Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:
1.	(a)
Brezplačne vzorce se izjemoma daje samo osebam, usposobljenim za njihovo predpisovanje, pod naslednjimi pogoji:	the number of samples for each medicinal product each year on prescription shall be limited;
(a)	(b)
število vzorcev za vsako zdravilo na recept mora biti vsako leto omejeno;	any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent;
(b)	(c)
vse vzorce se dostavi na pisno prošnjo, ki jo predpisovalec podpiše in opremi z datumom;	those supplying samples shall maintain an adequate system of control and accountability;
(c)	▼M4
o prejetih vzorcih se vodi ustrezen sistem nadzora in odgovornosti;	(d)
▼M4	each sample shall be no larger than the smallest presentation on the market;
(d)	▼B
noben vzorec ne sme biti večji od najmanjšega pakiranja na trgu;	(e)
▼B	each sample shall be marked ‘free medical sample — not for sale’ or shall show some other wording having the same meaning;
(e)	(f)
vsak vzorec mora biti označen z napisom „brezplačen zdravniški vzorec — ni za prodajo“, ali z drugimi besedami z enakim pomenom;	each sample shall be accompanied by a copy of the summary of product characteristics;
(f)	(g)
vsem vzorcem je priložen izvod povzetka glavnih značilnosti zdravila;	no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Conventions of 1961 and 1971, may be supplied.
(g)	2.
ne sme se dajati vzorcev zdravil, ki vsebujejo psihotropne ali narkotične snovi v smislu mednarodnih konvencij, kot sta konvenciji Združenih narodov iz leta 1961 in 1971.	Member States may also place further restrictions on the distribution of samples of certain medicinal products.
2.	Article 97
Države članice lahko še dodatno omejijo razdeljevanje vzorcev nekaterih zdravil.	1.
Člen 97	Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Title, may take legal action against such advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings.
1.	2.
Države članice zagotovijo ustrezne in učinkovite postopke za nadzor oglaševanja zdravil. Postopki, ki lahko temeljijo na sistemu predhodnega preučevanja in presoje, v vsakem primeru vključujejo pravne predpise, na podlagi katerih osebe ali organizacije, ki se po zakonodaji države članice štejejo, da imajo pravno utemeljen interes za prepoved vsakega oglaševanja, ki je v neskladju s tem naslovom, lahko pravno ukrepajo proti tovrstnemu oglaševanju ali prijavijo tak oglas upravnemu organu, ki je pristojen za odločanje o pritožbah ali za sprožitev ustreznega sodnega postopka.	Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary, taking into account all the interests involved, and in particular the public interest:
2.	—
Po pravnih predpisih iz odstavka 1 države članice dodelijo sodiščem ali upravnim organom pristojnosti, ki jim omogočajo, da v primerih, kadar sodijo, da so taki ukrepi potrebni, in ob upoštevanju vseh vpletenih interesov, zlasti interesa javnosti:	to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising, or
—	—
odredijo prenehanje oglaševanja, ali sprožijo ustrezen sodni postopek za izdajo odredbe o prenehanju zavajajočega oglaševanja, ali	if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication,
—	even without proof of actual loss or damage or of intention or negligence on the part of the advertiser.
če zavajajoči oglas še ni objavljen, se pa objava bliža, zahtevajo prepoved ali sprožijo ustrezen sodni postopek za prepoved take objave,	3.
tudi brez dokaza o dejanski izgubi ali škodi ali nameri ali malomarnosti s strani oglaševalca.	Member States shall make provision for the measures referred to in the second subparagraph to be taken under an accelerated procedure, either with interim effect or with definitive effect.
3.	It shall be for each Member State to decide which of the two options set out in the first subparagraph to select.
Države članice pripravijo določbe, da se ukrepi iz drugega pododstavka sprejmejo po pospešenem postopku z začasnim ali dokončnim učinkom.	4.
Države članice same odločijo, katero od obeh možnosti iz prvega pododstavka bodo izbrale.	Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision:
4.	—
S ciljem odstranitve nadaljnjih učinkov zavajajočega oglaševanja, za prenehanje katerega je bil izdan dokončen sklep, države članice lahko dodelijo sodiščem ali upravnim organom pristojnosti, ki jim omogočajo:	to require publication of that decision in full or in part and in such form as they deem adequate,
—	—
da zahtevajo objavo takega sklepa v celoti ali delno in v obliki, kakršni menijo, da je ustrezna,	to require in addition the publication of a corrective statement.
—	5.
da dodatno zahtevajo objavo popravka.	Paragraphs 1 to 4 shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1.
5.	Article 98
Odstavki 1 do 4 ne izključujejo prostovoljnega nadzora oglaševanja zdravil, ki ga opravljajo samonadzorni organi in možnosti, da se zatečejo k takim organom, če je poleg sodnih ali upravnih postopkov iz odstavka 1, postopek pred takim organom možen.	1.
Člen 98	The marketing authorization holder shall establish, within his undertaking, a scientific service in charge of information about the medicinal products which he places on the market.
1.	2.
Imetnik dovoljenja za promet z zdravilom v svojem podjetju vzpostavi strokovno službo, odgovorno za informacije o zdravilih, ki jih daje v promet.	The marketing authorization holder shall:
2.	—
Imetnik dovoljenja za promet z zdravilom:	keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination,
—	—
da na voljo ali sporoči organom ali službam, odgovornim za nadzor oglaševanja zdravil, vzorec vsakega oglasa, ki prihaja iz njegovega podjetja skupaj z izjavo, v kateri so navedene osebe, na katere je oglas naslovljen, način razširjanja oglasa ter datum prvega oglaševanja,	ensure that advertising of medicinal products by his undertaking conforms to the requirements of this Title,
—	—
zagotovi, da je oglaševanje zdravil, ki ga izvaja podjetje, v skladu z zahtevami tega naslova,	verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 93(2) and (3),
—	—
preveri, da so strokovni sodelavci za prodajo zdravil, ki jih podjetje zaposluje, ustrezno usposobljeni in izpolnjujejo zahteve iz člena 93(2) in (3),	supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities,
—	—
organom ali službam za nadzor oglaševanja zdravil predloži zahtevane informacije in nudi pomoč, ki jo zahtevajo za izvajanje svojih pristojnosti,	ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.
—	▼M4
zagotovi, da se sklepi organov ali služb za nadzor oglaševanja zdravil, takoj in v celoti upoštevajo.	3.
▼M4	The Member States shall not prohibit the co-promotion of a medicinal product by the holder of the marketing authorisation and one or more companies nominated by him.
3.	▼B
Države članice ne smejo prepovedati sodelovanja pri promociji zdravila med imetnikom dovoljenja za promet z zdravilom in enega ali več podjetij, ki jih ta imenuje.	Article 99
▼B	Member States shall take the appropriate measures to ensure that the provisions of this Title are applied and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of Title be infringed.
Člen 99	▼M4
Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da se določbe tega naslova izvajajo ter določijo zlasti kazni za kršitev določb, sprejetih za izvajanje tega naslova.	Article 100
▼M4	Advertising of the homeopathic medicinal products referred to in Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1).
Člen 100	However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products.
Za oglaševanje homeopatskih zdravil iz člena 14(1) se uporabljajo določbe tega naslova, z izjemo člena 87(1).	▼M10
Za oglaševanje teh zdravil se smejo uporabljati le informacije, navedene v členu 69(1).	TITLE IX
▼M10	PHARMACOVIGILANCE
NASLOV IX	CHAPTER 1
FARMAKOVIGILANCA	General provisions
POGLAVJE 1	Article 101
Splošne določbe	1.
Člen 101	Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in Union pharmacovigilance activities.
1.	The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, and to adverse reactions associated with occupational exposure.
Države članice vodijo sistem farmakovigilance za opravljanje svojih nalog farmakovigilance in sodelovanje v farmakovigilančnih dejavnostih Unije.	2.
Sistem farmakovigilance se uporablja za zbiranje informacij o tveganjih za zdravje bolnikov ali javno zdravje zaradi zdravil. Te informacije se zlasti nanašajo na neželene učinke pri ljudeh, ki izhajajo iz uporabe zdravila v okviru pogojev dovoljenja za promet z zdravilom in uporabe zunaj okvira pogojev dovoljenja za promet z zdravilom, ter na neželene učinke, ki so povezani s poklicno izpostavljenostjo.	Member States shall, by means of the pharmacovigilance system referred to in paragraph 1, evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action concerning the marketing authorisation as necessary. They shall perform a regular audit of their pharmacovigilance system and report the results to the Commission on 21 September 2013 at the latest and then every 2 years thereafter.
2.	3.
S sistemom farmakovigilance iz odstavka 1 države članice znanstveno ovrednotijo vse informacije, preučijo možnosti za zmanjšanje in preprečevanje tveganj in, če je to potrebno, sprejmejo ureditvene ukrepe v zvezi z dovoljenjem za promet z zdravilom. Sistem farmakovigilance redno presojajo in rezultate Komisiji sporočijo najpozneje 21. septembra 2013 in nato vsaki dve leti.	Each Member State shall designate a competent authority for the performance of pharmacovigilance tasks.
3.	4.
Vsaka država članica določi pristojni organ za opravljanje nalog farmakovigilance.	The Commission may request Member States to participate, under the coordination of the Agency, in international harmonisation and standardisation of technical measures in relation to pharmacovigilance.
4.	Article 102
Komisija lahko od držav članic zahteva, da sodelujejo v mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi s farmakovigilanco, ki ju vodi Agencija.	The Member States shall:
Člen 102	(a)
Države članice:	take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority; for these tasks, organisations representing consumers, patients and healthcare professionals may be involved as appropriate;
(a)	(b)
sprejmejo vse ustrezne ukrepe za spodbujanje bolnikov, zdravnikov, farmacevtov in drugih zdravstvenih delavcev, da nacionalnemu pristojnemu organu poročajo o domnevnih neželenih učinkih; v opravljanje teh nalog se lahko po potrebi vključijo organizacije potrošnikov, bolnikov in zdravstvenih delavcev;	facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats;
(b)	(c)
spodbujajo poročanje bolnikov z zagotovitvijo drugih možnih načinov poročanja poleg spletnih oblik;	take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;
(c)	(d)
sprejmejo vse ustrezne ukrepe za pridobitev natančnih in preverljivih podatkov za znanstveno vrednotenje poročil o domnevnih neželenih učinkih;	ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner through publication on the web-portal and through other means of publicly available information as necessary;
(d)	(e)
zagotovijo, da javnost dobi pomembne informacije o vprašanjih farmakovigilance glede uporabe zdravila s pravočasno objavo na spletem portalu in v drugih sredstvih obveščanja javnosti, kakor je potrebno;	ensure, through the methods for collecting information and where necessary through the follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify clearly any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction report, with due regard to the name of the medicinal product, in accordance with Article 1(20), and the batch number;
(e)	(f)
zagotovijo, z načini zbiranja informacij in po potrebi nadaljnjim spremljanjem poročil o domnevnih neželenih učinkih, da so sprejeti vsi ustrezni ukrepi, s katerimi se prepozna vsako biološko zdravilo, ki se predpiše, razdeli ali prodaja na njihovem ozemlju in je predmet poročila o domnevnih neželenih učinkih; ob ustreznem upoštevanju imena zdravila v skladu s členom 1(20) in številke serije;	take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in this Title is subject to effective, proportionate and dissuasive penalties.
(f)	For the purposes of point (a) and (e) of the first paragraph the Member States may impose specific obligations on doctors, pharmacists and other health-care professionals.
sprejmejo potrebne ukrepe za zagotovitev, da za imetnika dovoljenja za promet z zdravilom, ki ne izpolnjuje obveznosti iz tega naslova, veljajo učinkovite, sorazmerne in odvračalne kazni.	Article 103
Za namene točk (a) in (e) prvega odstavka lahko države članice naložijo zdravnikom, farmacevtom in drugim zdravstvenim delavcem posebne obveznosti.	A Member State may delegate any of the tasks entrusted to it under this Title to another Member State subject to a written agreement of the latter. Each Member State may represent no more than one other Member State.
Člen 103	The delegating Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that information public.
Država članica lahko prenese katero koli od nalog, ki so ji zaupane na podlagi tega naslova, na drugo državo članico na podlagi pisnega soglasja slednje. Vsaka država članica lahko zastopa največ še eno drugo državo članico.	Article 104
Država članica, ki prenese naloge, o tem pisno obvesti Komisijo, Agencijo in druge države članice. Država članica, ki prenese naloge, in Agencija tako informacijo objavita.	1.
Člen 104	The marketing authorisation holder shall operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks equivalent to the relevant Member State’s pharmacovigilance system provided for under Article 101(1).
1.	2.
Imetnik dovoljenja za promet z zdravilom izvaja sistem farmakovigilance za opravljanje nalog farmakovigilance, enakovreden sistemu farmakovigilance zadevne države članice v skladu s členom 101(1).	The marketing authorisation holder shall by means of the pharmacovigilance system referred to in paragraph 1 evaluate all information scientifically, consider options for risk minimisation and prevention and take appropriate measures as necessary.
2.	The marketing authorisation holder shall perform a regular audit of his pharmacovigilance system. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented. Once the corrective actions have been fully implemented, the note may be removed.
S sistemom farmakovigilance iz odstavka 1 imetnik dovoljenja za promet z zdravilom znanstveno ovrednoti vse informacije, preuči možnosti za zmanjšanje in preprečevanje tveganj in sprejme primerne ukrepe, kot je potrebno.	3.
Imetnik dovoljenja za promet z zdravilom redno presoja svoj sistem farmakovigilance. V glavni dosje o sistemu farmakovigilance vpiše opombo o glavnih ugotovitvah presoje in na podlagi teh ugotovitev zagotovi pripravo in izvedbo ustreznega načrta popravnih ukrepov. Opomba se lahko umakne po tem, ko so bili v celoti izvedeni popravni ukrepi.	As part of the pharmacovigilance system, the marketing authorisation holder shall:
3.	(a)
Kot del sistema farmakovigilance, imetnik dovoljenja za promet z zdravilom:	have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance;
(a)	(b)
trajno in stalno razpolaga z ustrezno usposobljeno osebo, ki je odgovorna za farmakovigilanco;	maintain and make available on request a pharmacovigilance system master file;
(b)	(c)
vodi in na zahtevo daje na voljo glavni dosje o sistemu farmakovigilance;	operate a risk management system for each medicinal product;
(c)	(d)
izvaja sistem obvladovanja tveganj za vsako zdravilo;	monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions of the marketing authorisation pursuant to Articles 21a, 22 or 22a;
(d)	(e)
spremlja izid ukrepov za zmanjšanje tveganj iz načrta za obvladovanje tveganj ali ki so določeni kot pogoji v dovoljenju za promet z zdravilom na podlagi členov 21a, 22 ali 22a;	update the risk management system and monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products.
(e)	The qualified person referred to in point (a) of the first subparagraph shall reside and operate in the Union and shall be responsible for the establishment and maintenance of the pharmacovigilance system. The marketing authorisation holder shall submit the name and contact details of the qualified person to the competent authority and the Agency.
posodablja sistem obvladovanja tveganj in spremlja podatke o farmakovigilanci, da ugotovi, ali je prišlo do novih tveganj ali da so se tveganja spremenila ter ali se je spremenilo razmerje med tveganjem in koristjo zdravil.	▼M16
Usposobljena oseba iz točke (a) prvega pododstavka prebiva in dela v Uniji in je odgovorna za vzpostavitev in vzdrževanje sistema farmakovigilance. Imetnik dovoljenja za promet pristojnemu organu in Agenciji predloži ime in kontaktne podatke usposobljene osebe.	By way of derogation from the second subparagraph, where the marketing authorisation is granted by the competent authority of United Kingdom in respect of Northern Ireland, the qualified person referred to in point (a) of the first subparagraph may reside and operate in parts of the United Kingdom other than Northern Ireland. This subparagraph shall not apply where the marketing authorisation holder already has at its disposal a qualified person who resides and operates in the Union on 20 April 2022.
▼M16	▼M10
Z odstopanjem od drugega pododstavka lahko, kadar dovoljenje za promet izda pristojni organ Združenega kraljestva v zvezi s Severno Irsko, usposobljena oseba iz prvega pododstavka, točke (a), prebiva in deluje v delih Združenega kraljestva razen Severne Irske. Ta pododstavek se ne uporablja, kadar ima imetnik dovoljenja za promet dne 20. aprila 2022 že na voljo usposobljeno osebo, ki prebiva in deluje v Uniji.	4.
▼M10	Notwithstanding the provisions of paragraph 3, national competent authorities may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.
4.	Article 104a
Ne glede na določbe odstavka 3, lahko pristojni nacionalni organi zahtevajo imenovanje kontaktne osebe za vprašanja farmakovigilance na nacionalni ravni, ki poroča usposobljeni osebi, odgovorni za dejavnosti farmakovigilance.	1.
Člen 104a	Without prejudice to paragraphs 2, 3 and 4 of this Article, holders of marketing authorisations granted before 21 July 2012 shall, by way of derogation from Article 104(3)(c), not be required to operate a risk management system for each medicinal product.
1.	2.
Brez poseganja v odstavke 2, 3 in 4 tega člena in z odstopanjem od točke (c) člena 104(3) imetnikom dovoljenj za promet z zdravili, ki so bila izdana pred 21. julijem 2012, ni treba izvajati sistema obvladovanja tveganj za vsako zdravilo.	The national competent authority may impose an obligation on a marketing authorisation holder to operate a risk management system, as referred to in Article 104(3)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product. In that context, the national competent authority shall also oblige the marketing authorisation holder to submit a detailed description of the risk-management system which he intends to introduce for the medicinal product concerned.
2.	The imposition of such obligations shall be duly justified, notified in writing and shall include the timeframe for submission of the detailed description of the risk-management system.
Pristojni nacionalni organ lahko imetniku dovoljenja za promet z zdravilom naloži obveznost izvajanja sistema obvladovanja tveganj iz točke (c) člena 104(3), če ostajajo varnostni zadržki glede zdravila, ki bi lahko vplivali na razmerje med tveganjem in koristjo zdravila, ki je pridobilo dovoljenje za promet. V ta namen pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom naloži obveznost predložitve podrobnega opisa sistema obvladovanja tveganj, ki ga namerava uvesti za zadevno zdravilo.	3.
Naložitev te obveznosti se ustrezno utemelji in se pisno uradno sporoči ter vsebuje časovni okvir za predložitev podrobnega opisa sistema obvladovanja tveganj.	The national competent authority shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.
3.	4.
Pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom da možnost, da predloži pisne obrazložitve kot odgovor na naložitev obveznosti v roku, ki ga določi organ, če imetnik dovoljenja za promet z zdravilom to zahteva v 30 dneh od prejema pisnega uradnega obvestila o obveznosti.	On the basis of the written observations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the obligation. Where the national competent authority confirms the obligation, the marketing authorisation shall be varied accordingly to include the measures to be taken as part of the risk management system as conditions of the marketing authorisation referred to in point (a) of Article 21a.
4.	Article 105
Pristojni nacionalni organ na podlagi pisnih obrazložitev, ki jih predloži imetnik dovoljenja za promet z zdravilom, umakne ali potrdi obveznosti. Kadar pristojni nacionalni organ potrdi obveznosti, se dovoljenje za promet z zdravilom ustrezno spremeni tako, da vključuje ukrepe, ki se bodo sprejeli v okviru sistema obvladovanja tveganj, kot pogoje za dovoljenje za promet z zdravilom v skladu s točko (a) člena 21a.	The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the national competent authorities in order to guarantee their independence in the performance of those pharmacovigilance activities.
Člen 105	The first paragraph shall not preclude the national competent authorities from charging fees to marketing authorisation holders for performing those activities by the national competent authorities on the condition that their independence in the performance of those pharmacovigilance activities is strictly guaranteed.
Upravljanje sredstev, namenjenih za dejavnosti, ki so povezane s farmakovigilanco, delovanje komunikacijskih mrež in tržni nadzor so pod stalnim nadzorom pristojnih nacionalnih organov, da se zagotovi njihova neodvisnost pri opravljanju teh dejavnosti farmakovigilance.	CHAPTER 2
Prvi odstavek ne izključuje možnosti pristojnih nacionalnih organov, da imetnikom dovoljenj za promet z zdravili zaračunavajo pristojbine za navedene dejavnosti, ki jih opravljajo pristojni nacionalni organi, pod pogojem, da je njihova neodvisnost pri opravljanju teh dejavnosti farmakovigilance strogo zajamčena.	Transparency and communications
POGLAVJE 2	Article 106
Preglednost in obveščanje	Each Member State shall set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines web-portals, the Member States shall make publicly available at least the following:
Člen 106	(a)
Vsaka država članica vzpostavi in vzdržuje nacionalni spletni portal o zdravilih, ki je povezan z evropskim spletnim portalom o zdravilih, vzpostavljenim v skladu s členom 26 Uredbe (ES) št. 726/2004. Na nacionalnih spletnih portalih o zdravilih države članice objavijo najmanj naslednje:	public assessment reports, together with a summary thereof;
(a)	(b)
javna poročila o oceni zdravila, skupaj s povzetkom le-teh;	summaries of product characteristics and package leaflets;
(b)	(c)
povzetke glavnih značilnosti zdravil in navodila za uporabo za bolnika;	summaries of risk management plans for medicinal products authorised in accordance with this Directive;
(c)	(d)
povzetke načrtov za obvladovanje tveganj za zdravila, odobrena v skladu s to direktivo;	the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004;
(d)	(e)
seznam zdravil iz člena 23 Uredbe (ES) št. 726/2004;	information on the different ways of reporting suspected adverse reactions to medicinal products to national competent authorities by healthcare professionals and patients, including the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004.
(e)	Article 106a
informacije o različnih načinih poročanja o domnevnih neželenih učinkih zdravil nacionalnim pristojnim organom s strani zdravstvenih delavcev in bolnikov, vključno s spletnimi strukturiranimi obrazci iz člena 25 Uredbe (ES) št. 726/2004.	1.
Člen 106a	As soon as the marketing authorisation holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, he shall be required to inform the national competent authorities, the Agency and the Commission.
1.	The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading.
Takoj ko namerava imetnik dovoljenja za promet z zdravilom objaviti obvestilo v zvezi z informacijami o vprašanjih farmakovigilance glede uporabe zdravila, mora istočasno ali pred javno objavo o tem obvestiti nacionalne pristojne organe, Agencijo in Komisijo.	2.
Imetnik dovoljenja za promet z zdravilom zagotovi, da so informacije javnosti predstavljene objektivno in da niso zavajajoče.	Unless urgent public announcements are required for the protection of public health, the Member States, the Agency and the Commission shall inform each other not less than 24 hours prior to a public announcement relating to information on pharmacovigilance concerns.
2.	3.
Razen če je zaradi varovanja javnega zdravja potrebno nujno javno obvestilo, se države članice, Agencija in Komisija medsebojno obvestijo najpozneje 24 ur pred javnim obvestilom, ki se nanaša na informacije o vprašanjih farmakovigilance.	For active substances contained in medicinal products authorised in more than one Member State, the Agency shall be responsible for the coordination between national competent authorities of safety announcements and shall provide timetables for the information being made public.
3.	Under the coordination of the Agency, the Member States shall make all reasonable efforts to agree on a common message in relation to the safety of the medicinal product concerned and the timetables for their distribution. The Pharmacovigilance Risk Assessment Committee shall, at the request of the Agency, provide advice on those safety announcements.
Pri zdravilnih učinkovinah v zdravilih, ki so odobrena v več kot eni državi članici, je Agencija odgovorna za usklajevanje varnostnih sporočil med pristojnimi nacionalnimi organi in zagotovitev časovnega razporeda objave informacij.	4.
Države članice si v usklajevanju, ki ga vodi Agencija, primerno prizadevajo za soglasje o skupnih sporočilih v zvezi z varnostjo in časovnem razporedu razširjanja. Odbor za ocenjevanje tveganja na področju farmakovigilance na zahtevo Agencije svetuje o navedenih varnostnih sporočilih.	When the Agency or national competent authorities make public information referred to in paragraphs 2 and 3, any information of a personal or commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health.
4.	CHAPTER 3
Ko Agencija ali pristojni nacionalni organi objavijo informacije iz odstavkov 2 in 3, izbrišejo vse osebne ali poslovno zaupne podatke, razen če je javno razkritje potrebno zaradi varovanja javnega zdravja.	Recording, reporting and assessment of pharmacovigilance data
POGLAVJE 3	Section 1
Evidentiranje, poročanje in ocenjevanje podatkov o farmakovigilanci	Recording and reporting of suspected adverse reactions
Oddelek 1	Article 107
Evidentiranje in poročanje o domnevnih neželenih učinkih	1.
Člen 107	Marketing authorisation holders shall record all suspected adverse reactions in the Union or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals, or occurring in the context of a post-authorisation study.
1.	Marketing authorisation holders shall ensure that those reports are accessible at a single point within the Union.
Imetniki dovoljenj za promet z zdravili vodijo dokumentacijo o vseh domnevnih neželenih učinkih v Uniji ali v tretjih državah, na katere jih spontano opozorijo bolniki sami ali zdravstveni delavci ali pa se pojavijo v okviru študije o zdravilu po pridobitvi dovoljenja za promet.	By way of derogation from the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC.
Imetniki dovoljenj za promet z zdravili zagotovi dostopnost navedenih poročil na eni sami točki v Uniji.	2.
Z odstopanjem od prvega pododstavka se domnevni neželeni učinki, ki se pojavijo v okviru kliničnih preskušanj, evidentirajo in sporočijo v skladu z Direktivo 2001/20/ES.	Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients and healthcare professionals.
2.	3.
Imetniki dovoljenj za promet z zdravili ne zavrnejo poročil o domnevnih neželenih učinkih, ki jih od bolnikov in zdravstvenih delavcev prejmejo elektronsko ali na kateri koli drug ustrezen način.	Marketing authorisation holders shall submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as the ‘Eudravigilance database’) information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the marketing authorisation holder concerned gained knowledge of the event.
3.	Marketing authorisation holders shall submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the marketing authorisation holder concerned gained knowledge of the event.
Imetniki dovoljenj za promet z zdravili elektronsko posredujejo podatke o vseh domnevnih resnih neželenih učinkih, ki se pojavijo v Uniji in v tretjih državah, v podatkovno bazo in omrežje za obdelavo podatkov iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: „podatkovna baza Eudravigilance“) v 15 dneh po dnevu, ko je zadevni imetnik dovoljenja za promet z zdravilom izvedel za dogodek.	For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions.
Imetniki dovoljenj za promet z zdravili elektronsko posredujejo podatke o vseh domnevnih neželenih učinkih, ki niso resni in se pojavijo v Uniji, v podatkovno bazo Eudravigilance v 90 dneh po dnevu, ko je zadevni imetnik dovoljenja za promet z zdravilom izvedel za dogodek.	4.
Za zdravila, ki vsebujejo zdravilne učinkovine s seznama publikacij, ki jih spremlja Agencija na podlagi člena 27 Uredbe (ES) št. 726/2004, imetnikom dovoljenja za promet z zdravili v podatkovno bazo Eudravigilance ni treba sporočati domnevnih neželenih učinkov, opisanih v navedeni medicinski literaturi, vendar spremljajo vso ostalo medicinsko literaturo in poročajo o morebitnih domnevnih neželenih učinkih.	Marketing authorisation holders shall establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports. They shall also collect follow-up information on these reports and submit the updates to the Eudravigilance database.
4.	5.
Imetniki dovoljenj za promet z zdravili vzpostavijo postopke za pridobitev natančnih in preverljivih podatkov za znanstveno vrednotenje poročil o domnevnih neželenih učinkih. Zbirajo tudi nadaljnje informacije o teh poročilih ter posodobljene informacije predložijo v podatkovno bazo Eudravigilance.	Marketing authorisation holders shall collaborate with the Agency and the Member States in the detection of duplicates of suspected adverse reaction reports.
5.	Article 107a
Imetniki dovoljenj za promet z zdravili sodeluje z Agencijo in državami članicami pri odkrivanju dvojnikov poročil o domnevnih neželenih učinkih.	1.
Člen 107a	Each Member State shall record all suspected adverse reactions that occur in its territory which are brought to its attention from healthcare professionals and patients. Member States shall involve patients and healthcare professionals, as appropriate, in the follow-up of any reports they receive in order to comply with Article 102(c) and (e).
1.	Member States shall ensure that reports of such reactions may be submitted by means of the national medicines web-portals or by other means.
Vsaka država članica evidentira vse domnevne neželene učinke, ki se pojavijo na njenem ozemlju, na katere jo opozorijo zdravstveni delavci in bolniki. Države članice vključijo bolnike in zdravstvene delavce, kot je primerno, v spremljanje vseh poročil, ki jih prejme, da bi izpolnile točke (c) in (e) iz člena 102.	2.
Države članice zagotovijo, da se poročila o takih učinkih lahko predložijo s pomočjo nacionalnih spletnih portalov o zdravilih ali na drug način.	For reports submitted by a marketing authorisation holder, Member States on whose territory the suspected adverse reaction occurred may involve the marketing authorisation holder in the follow-up of the reports.
2.	3.
Pri poročilih, ki jih predloži imetnik dovoljenja za promet, lahko država članica, na ozemlju katere so se pojavili domnevni neželeni učinki, vključi imetnika dovoljenja za promet z zdravilom v nadaljnje spremljanje teh poročil.	Member States shall collaborate with the Agency and the marketing authorisation holders in the detection of duplicates of suspected adverse reaction reports.
3.	4.
Države članice sodelujejo z Agencijo in imetniki dovoljenj za promet pri odkrivanju dvojnikov poročil o domnevnih neželenih učinkih.	Member States shall, within 15 days following the receipt of the reports of serious suspected adverse reactions referred to in paragraph 1, submit the reports electronically to the Eudravigilance database.
4.	They shall, within 90 days from the receipt of reports referred to in paragraph 1, submit reports of non-serious suspected adverse reactions electronically to the Eudravigilance database.
Države članice v 15 dneh od prejema poročil o domnevnih resnih neželenih učinkih iz odstavka 1, poročila elektronsko predložijo v podatkovno bazo Eudravigilance.	Marketing authorisation holders shall access those reports through the Eudravigilance database.
V 90 dneh od prejema poročil iz odstavka 1 elektronsko predložijo v podatkovno bazo Eudravigilance poročila o domnevnih neželenih učinkih zdravil, ki niso resni.	5.
Imetniki dovoljenj za promet z zdravili imajo dostop do teh poročil preko podatkovne baze Eudravigilance.	Member States shall ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations and/or institutions, responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 25 of Regulation (EC) No 726/2004.
5.	6.
Države članice zagotovijo, da so poročila o domnevnih neželenih učinkih, ki so posledica napake, povezane z uporabo zdravila, na katera so opozorjene, na voljo podatkovni bazi Eudravigilance in vsem organom, uradom, organizacijam in/ali institucijam, odgovornim za varnost bolnikov v navedeni državi članici. Zagotovijo tudi, da so organi, odgovorni za zdravila v navedeni državi članici, obveščeni o vseh domnevnih neželenih učinkih, na katere so bili opozorjeni kateri koli drugi organi v tej državi članici. Ta poročila se ustrezno zabeležijo v obliki iz člena 25 Uredbe (ES) št. 726/2004.	Unless there are justifiable grounds resulting from pharmacovigilance activities, individual Member States shall not impose any additional obligations on marketing authorisation holders for the reporting of suspected adverse reactions.
6.	Section 2
Posamezne države članice imetnikom dovoljenj za promet z zdravili ne nalagajo nobenih dodatnih obveznosti glede poročanja o domnevnih neželenih učinkih, razen iz utemeljenih razlogov, ki izhajajo iz dejavnosti farmakovigilance.	Periodic safety update reports
Oddelek 2	Article 107b
Redna posodobljena poročila o varnosti zdravila	1.
Člen 107b	Marketing authorisation holders shall submit to the Agency periodic safety update reports containing:
1.	(a)
Imetniki dovoljenj za promet z zdravili posredujejo Agenciji redna posodobljena poročila o varnosti zdravila, ki vsebujejo:	summaries of data relevant to the benefits and risks of the medicinal product, including results of all studies with a consideration of their potential impact on the marketing authorisation;
(a)	(b)
povzetke podatkov, pomembnih za koristi in tveganja zdravila, vključno z rezultati vseh študij ob upoštevanju morebitnega vpliva na dovoljenje za promet z zdravilom;	a scientific evaluation of the risk-benefit balance of the medicinal product;
(b)	(c)
znanstveno vrednotenje razmerja med tveganjem in koristjo zdravila;	all data relating to the volume of sales of the medicinal product and any data in possession of the marketing authorisation holder relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product.
(c)	The evaluation referred to in point (b) shall be based on all available data, including data from clinical trials in unauthorised indications and populations.
vse podatke, ki se nanašajo na obseg prodaje zdravila, in vse podatke, ki jih ima imetnik dovoljenja za promet z zdravilom o številu receptov, vključno z oceno o tem, koliko prebivalstva je izpostavljenega zdravilu.	The periodic safety update reports shall be submitted electronically.
Vrednotenje iz točke (b) temelji na vseh razpoložljivih podatkih, vključno s podatki iz kliničnih preskušanj pri neodobrenih indikacijah in populacijah.	2.
Redna posodobljena poročila o varnosti zdravil se posreduje elektronsko.	The Agency shall make available the reports referred to in paragraph 1 to the national competent authorities, the members of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group by means of the repository referred to in Article 25a of Regulation (EC) No 726/2004.
2.	3.
Agencija da na voljo poročila iz odstavka 1 pristojnim nacionalnim organom, članom Odbora za ocenjevanje tveganja na področju farmakovigilance, Odboru za zdravila za uporabo v humani medicini in skupini za usklajevanje z arhivom iz člena 25a Uredbe (ES) št. 726/2004.	By way of derogation from paragraph 1 of this Article, the holders of marketing authorisations for medicinal products referred to in Article 10(1), or Article 10a, and the holders of registrations for medicinal products referred to in Articles 14 or 16a, shall submit periodic safety update reports for such medicinal products in the following cases:
3.	(a)
Z odstopanjem od odstavka 1 tega člena, imetniki dovoljenj za promet z zdravili iz člena 10(1) ali člena 10a ter imetniki dovoljenj za promet z zdravili iz člena 14 ali 16a predložijo redna posodobljena poročila o varnosti zdravila v naslednjih primerih:	where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or
(a)	(b)
kadar je taka obveznost predpisana kot pogoj v dovoljenju za promet z zdravilom v skladu s členom 21a ali členom 22; ali	when requested by a competent authority on the basis of concerns relating to pharmacovigilance data or due to the lack of periodic safety update reports relating to an active substance after the marketing authorisation has been granted. The assessment reports of the requested periodic safety update reports shall be communicated to the Pharmacovigilance Risk Assessment Committee, which shall consider whether there is a need for a single assessment report for all marketing authorisations for medicinal products containing the same active substance and inform the coordination group or the Committee for Medicinal Products for Human Use accordingly, in order to apply the procedures laid down in Article 107c(4) and Article 107e.
(b)	Article 107c
ko to zahteva pristojni organ na podlagi pomislekov glede podatkov o farmakovigilanci ali zato, ker niso bila predložena redna posodobljena poročila o varnostnih podatkih, povezanih z zdravilno učinkovino, po tem ko je bilo izdano dovoljenje za promet z zdravilom. Poročila o oceni zahtevanih rednih posodobljenih poročil o varnosti zdravila se posredujejo Odboru za ocenjevanje tveganja na področju farmakovigilance, ki preuči, ali je potrebno eno samo poročilo o oceni za vsa dovoljenja za promet z zdravili, ki vsebujejo isto zdravilno učinkovino, ter ustrezno obvesti skupino za usklajevanje ali Odbor za zdravila za uporabo v humani medicini, da se uporabijo postopki iz člena 107c(4) in člena 107e.	1.
Člen 107c	The frequency with which the periodic safety update reports are to be submitted shall be specified in the marketing authorisation.
1.	The dates of submission according to the specified frequency shall be calculated from the date of the authorisation.
Pogostost predložitve rednih posodobljenih poročil o varnosti zdravila je določena v dovoljenju za promet.	2.
Datumi predložitve se glede na odobreno pogostost določijo glede na datum izdaje dovoljenja za promet z zdravilom.	Holders of marketing authorisations which were granted before 21 July 2012, and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation, shall submit the periodic safety update reports in accordance with the second subparagraph of this paragraph until another frequency or other dates of submission of the reports are laid down in the marketing authorisation or determined in accordance with paragraphs 4, 5 or 6.
2.	Periodic safety update reports shall be submitted to the competent authorities immediately upon request or in accordance with the following:
Imetniki dovoljenj za promet z zdravili, ki so bila izdana pred 21. julijem 2012 in za katera pogostost in datumi predložitve rednih posodobljenih poročil o varnosti zdravila niso predpisani v pogojih dovoljenja za promet z zdravilom, redna posodobljena poročila o varnosti zdravila predložijo v skladu z drugim pododstavkom tega odstavka, dokler se v dovoljenju za promet ne določi drugačna pogostost ali drugi datumi predložitve poročil, ali pa se drugačna pogostost ali drugi datumi določijo v skladu z odstavki 4, 5 ali 6.	(a)
Redna posodobljena poročila o varnosti zdravila se predložijo pristojnim organom na zahtevo takoj ali v skladu z naslednjim:	where a medicinal product has not yet been placed on the market, at least every 6 months following authorisation and until the placing on the market;
(a)	(b)
kadar zdravilo še ni bilo dano v promet, najmanj vsakih šest mesecev po izdaji dovoljenja za promet z zdravilom in do trenutka, ko je zdravilo dano v promet;	where a medicinal product has been placed on the market, at least every 6 months during the first 2 years following the initial placing on the market, once a year for the following 2 years and at three-yearly intervals thereafter.
(b)	3.
kadar je bilo zdravilo dano v promet, vsaj vsakih šest mesecev v prvih dveh letih po začetku dajanja zdravila v promet, enkrat letno v naslednjih dveh letih in v triletnih intervalih po tem.	Paragraph 2 shall also apply to medicinal products which are authorised only in one Member State and for which paragraph 4 does not apply.
3.	4.
Odstavek 2 se uporablja tudi za zdravila, ki so odobrena samo v eni državi članici in za katera se ne uporablja odstavek 4.	Where medicinal products that are subject to different marketing authorisations contain the same active substance or the same combination of active substances, the frequency and dates of submission of the periodic safety update reports resulting from the application of paragraphs 1 and 2 may be amended and harmonised to enable a single assessment to be made in the context of a periodic safety update report work-sharing procedure and to set a Union reference date from which the submission dates are calculated.
4.	This harmonised frequency for the submission of the reports and the Union reference date may be determined, after consultation of the Pharmacovigilance Risk Assessment Committee, by one of the following:
Kadar zdravila, ki so predmet različnih dovoljenj za promet z zdravili, vsebujejo isto zdravilno učinkovino ali isto kombinacijo zdravilnih učinkovin, se pogostost in datumi predložitve rednih posodobljenih poročil o varnosti zdravila, ki izhajajo iz uporabe odstavkov 1 in 2, lahko spremenijo in uskladijo, da se omogoči enotna ocena v povezavi s postopkom delitve dela za redno posodobljeno poročilo o varnosti zdravila in da se določi referenčni datum Unije, od katerega se določa datum predložitve.	(a)
To usklajeno pogostost za predložitev poročil in referenčni datum Unije lahko po posvetovanju z Odborom za ocenjevanje tveganja na področju farmakovigilance določi eden od naslednjih:	the Committee for Medicinal Products for Human Use, where at least one of the marketing authorisations for the medicinal products containing the active substance concerned has been granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004;
(a)	(b)
Odbor za zdravila za uporabo v humani medicini, kadar je bilo vsaj eno od dovoljenj za promet za zdravila, ki vsebujejo zadevne zdravilne učinkovine, izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004;	the coordination group, in other cases than those referred to in point (a).
(b)	The harmonised frequency for the submission of the reports determined pursuant to the first and second subparagraphs shall be made public by the Agency. Marketing authorisation holders shall submit an application for a variation of the marketing authorisation accordingly.
skupina za usklajevanje, v primerih, ki niso navedeni v točki (a).	5.
Usklajeno pogostost za predložitev poročil določeno v skladu s prvim in drugim pododstavkom objavi Agencija. Imetniki dovoljenj za promet z zdravili skladno s tem predložijo vlogo za spremembo dovoljenja za promet z zdravilom.	For the purposes of paragraph 4, the Union reference date for medicinal products containing the same active substance or the same combination of active substances shall be one of the following:
5.	(a)
Za namene odstavka 4 je referenčni datum Unije za zdravila, ki vsebujejo isto zdravilno učinkovino ali isto kombinacijo zdravilnih učinkovin, eden od naslednjih:	the date of the first marketing authorisation in the Union of a medicinal product containing that active substance or that combination active substances;
(a)	(b)
datum prvega dovoljenja za promet v Uniji za zdravilo, ki vsebuje to zdravilno učinkovino ali to kombinacijo zdravilnih učinkovin;	if the date referred to in point (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations for a medicinal product containing that active substance or that combination of active substances.
(b)	6.
če datuma iz točke (a) ni mogoče določiti, prvi znani datum dovoljenja za promet za zdravilo, ki vsebuje to zdravilno učinkovino ali to kombinacijo zdravilnih učinkovin.	Marketing authorisation holders shall be allowed to submit requests to the Committee for Medicinal Products for Human Use or the coordination group, as appropriate, to determine Union reference dates or to change the frequency of submission periodic safety update reports on one of the following grounds:
6.	(a)
Imetniki dovoljenj za promet z zdravili lahko Odboru za zdravila za uporabo v humani medicini ali skupini za usklajevanje predložijo zahtevo za določitev referenčnih datumov v Uniji ali spremembo pogostosti predložitve rednih posodobljenih poročil o varnosti zdravila:	for reasons relating to public health;
(a)	(b)
iz razlogov javnega zdravja;	in order to avoid a duplication of the assessment;
(b)	(c)
da se prepreči podvajanje ocenjevanja;	in order to achieve international harmonisation.
(c)	Such requests shall be submitted in writing and shall be duly justified. The Committee for Medicinal Products for Human Use or the coordination group shall, following the consultation with the Pharmacovigilance Risk Assessment Committee, shall either approve or deny such requests. Any change in the dates or the frequency of submission of periodic safety update reports shall be made public by the Agency. The marketing authorisation holders shall accordingly submit an application for a variation of the marketing authorisation.
da se doseže mednarodna usklajenost.	7.
Take zahteve se predložijo pisno in so ustrezno utemeljene. Odbor za zdravila za uporabo v humani medicini ali skupina za usklajevanje po posvetovanju z Odborom za ocenjevanje tveganja na področju farmakovigilance bodisi odobri bodisi zavrne takšne zahteve. Vsako spremembo datumov ali pogostosti predložitve rednih posodobljenih poročil o varnosti zdravila objavi Agencija. Imetniki dovoljenj za promet z zdravili skladno s tem predložijo vlogo za spremembo dovoljenj za promet z zdravili.	The Agency shall make public a list of Union reference dates and frequency of submission of periodic safety update reports by means of the European medicines web-portal.
7.	Any change to the dates of submission and frequency of periodic safety update reports specified in the marketing authorisation as a result of the application of paragraphs 4, 5 and 6 shall take effect 6 months after the date of such publication.
Agencija objavi seznam referenčnih datumov Unije in pogostost predložitve rednih posodobljenih poročil o varnosti zdravila na evropskem spletnem portalu o zdravilih.	Article 107d
Vsaka sprememba datumov predložitve in pogostosti rednih posodobljenih poročil o varnosti zdravila, določenih v dovoljenju za promet z zdravilom, zaradi uporabe odstavkov 4, 5 in 6 začnejo veljati šest mesecev od dneva take objave.	The national competent authorities shall assess periodic safety update reports to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance of medicinal products.
Člen 107d	Article 107e
Pristojni nacionalni organi ocenjujejo redna posodobljena poročila o varnosti zdravila, da ugotovijo, ali je prišlo do novih tveganj ali da so se tveganja spremenila ter ali se je spremenilo razmerje med tveganjem in koristjo zdravil.	1.
Člen 107e	A single assessment of periodic safety update reports shall be performed for medicinal products authorised in more than one Member State and, in the cases of paragraphs 4 to 6 of Article 107c, for all medicinal products containing the same active substance or the same combination of active substances and for which a Union reference date and frequency of periodic safety update reports has been established.
1.	The single assessment shall be conducted by either of the following:
Enotno ocenjevanje rednih posodobljenih poročil o varnosti zdravila se opravi za zdravila, ki so odobrena v več kot eni državi članici, v primerih odstavkov 4 do 6 člena 107c pa za vsa zdravila, ki vsebujejo isto zdravilno učinkovino ali isto kombinacijo zdravilnih učinkovin z drugimi zdravilnimi učinkovinami in za katera sta bila določena referenčni datum Unije in pogostost rednih posodobljenih poročil o varnosti zdravila.	(a)
Enotno oceno opravi eden od naslednjih:	a Member State appointed by the coordination group where none of the marketing authorisations concerned has been granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004; or
(a)	(b)
država članica, ki jo imenuje skupina za usklajevanje, kadar nobeno od zadevnih dovoljenj za promet z zdravilom ni bilo izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004; ali	a rapporteur appointed by the Pharmacovigilance Risk Assessment Committee, where at least one of the marketing authorisations concerned has been granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004.
(b)	When selecting the Member State in accordance with point (a) of the second subparagraph, the coordination group shall take into account whether any Member State is acting as a reference Member State, in accordance with Article 28(1).
poročevalec, ki ga imenuje Odbor za ocenjevanje tveganja na področju farmakovigilance, kadar je bilo vsaj eno od zadevnih dovoljenj za promet z zdravilom izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004.	2.
Skupina za usklajevanje pri izbiri države članice v skladu s točko (a) drugega pododstavka upošteva, ali kakšna država članica opravlja funkcijo referenčne države članice, v skladu s členom 28(1).	The Member State or rapporteur, as appropriate, shall prepare an assessment report within 60 days of receipt of the periodic safety update report and send it to the Agency and to the Member States concerned. The Agency shall send the report to the marketing authorisation holder.
2.	Within 30 days of receipt of the assessment report, the Member States and the marketing authorisation holder may submit comments to the Agency and to the rapporteur or Member State.
Država članica ali poročevalec pripravi poročilo o oceni v 60 dneh po prejemu rednega posodobljenega poročila o varnosti zdravila in ga pošlje Agenciji in zadevnim državam članicam. Agencija posreduje poročilo imetniku dovoljenja za promet z zdravilom.	3.
V 30 dneh od prejema poročila o oceni lahko države članice in imetnik dovoljenja za promet z zdravilom predložijo pripombe Agenciji in poročevalcu ali državi članici.	Following the receipt of the comments referred to in paragraph 2, the rapporteur or Member State shall within 15 days update the assessment report taking into account any comments submitted, and forward it to the Pharmacovigilance Risk Assessment Committee. The Pharmacovigilance Risk Assessment Committee shall adopt the assessment report with or without further changes at its next meeting and issue a recommendation. The recommendation shall mention the divergent positions with the grounds on which they are based. The Agency shall include the adopted assessment report and the recommendation in the repository set up under Article 25a of Regulation (EC) No 726/2004 and forward both to the marketing authorisation holder.
3.	Article 107f
Po prejemu pripomb iz odstavka 2 poročevalec ali država članica v 15 dneh posodobi poročilo o oceni, pri čemer upošteva vse posredovane pripombe, in ga posreduje Odboru za ocenjevanje tveganja na področju farmakovigilance. Navedeni odbor na svojem naslednjem sestanku sprejme poročilo o oceni z nadaljnjimi spremembami ali brez njih in izda priporočilo. V priporočilu se navedejo različna stališča, vključno z njihovimi utemeljitvami. Agencija vključi sprejeto poročilo o oceni in priporočilo v arhiv, vzpostavljen na podlagi člena 25a Uredbe (ES) št. 726/2004 in ju posreduje imetniku dovoljenja za promet z zdravilom.	Following the assessment of periodic safety update reports, the national competent authorities shall consider whether any action concerning the marketing authorisation for the medicinal product concerned is necessary.
Člen 107f	They shall maintain, vary, suspend or revoke the marketing authorisation as appropriate.
Pristojni nacionalni organi po oceni rednih posodobljenih poročil o varnosti zdravila preučijo, ali so za zadevno zdravilo potrebni kakršni koli ukrepi glede dovoljenja za promet za zadevno zdravilo.	Article 107g
Če je to primerno, ohranijo, spremenijo, začasno prekličejo ali ukinejo dovoljenje za promet z zdravilom.	1.
Člen 107g	In the case of a single assessment of periodic safety update reports that recommends any action concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Committee, consider the report and reach a position on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the agreed position.
1.	2.
V primeru enotne ocene rednih posodobljenih poročil o varnosti zdravila, ki priporoča kakršen koli ukrep, ki zadeva pogoje več kot enega dovoljenja za promet v skladu s členom 107e(1), ki ne vključuje nobenega dovoljenja za promet z zdravilom, izdanega v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po prejemu poročila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči poročilo in sprejme stališče o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet, vključno s časovnim razporedom za izvajanje sprejetega stališča.	If, within the coordination group, the Member States represented reach agreement on the action to be taken by consensus, the chairman shall record the agreement and send it to the marketing authorisation holder and the Member States. The Member States shall adopt necessary measures to maintain, vary, suspend or revoke the marketing authorisations concerned in accordance with the timetable for implementation determined in the agreement.
2.	In the event of a variation, the marketing authorisation holder shall submit to the national competent authorities an appropriate application for a modification, including an updated summary of product characteristics and package leaflet within the determined timetable for implementation.
Če v okviru skupine za usklajevanje zastopane države članice soglasno dosežejo dogovor o ukrepih, ki se sprejmejo, predsednik zabeleži strinjanje in to posreduje imetniku dovoljenja za promet z zdravilom in državam članicam. Države članice sprejmejo ustrezne ukrepe, da ohranijo, spremenijo, začasno prekličejo ali ukinejo zadevno dovoljenje za promet z zdravilom v skladu s časovnim razporedom za izvajanje, določenim v dogovoru.	If an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34.
V primeru spremembe, imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži ustrezno prošnjo za spremembo, vključno s posodobljenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo v določenem časovnem razporedu za izvajanje.	Where the agreement reached by the Member States represented within the coordination group or the position of the majority of Member States differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or the majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če dogovora ni mogoče doseči soglasno, se stališče večine zastopanih držav članic v okviru skupine za usklajevanje posreduje Komisiji, ki uporabi postopek, določen v členih 33 in 34.	3.
Če se dogovor, ki so ga v skupini za usklajevanje dosegle zastopane države članice, ali stališče večine držav članic razlikuje od priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, koordinacijska skupina temu dogovoru oziroma stališču večine priloži podrobno razlago za razhajanja skupaj s priporočilom.	In the case of a single assessment of periodic safety update reports that recommends any action concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.
3.	Where this opinion of the Committee for Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences together with the recommendation.
V primeru enotne ocene rednih posodobljenih poročil o varnosti zdravila, ki priporočajo kakršne koli ukrepe, ki zadevajo več kot eno dovoljenje za promet z zdravilom v skladu s členom 107e(1), ki vključuje vsaj eno dovoljenje za promet z zdravilom, izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu poročila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet z zdravilom, vključno s časovnim razporedom za izvajanje mnenja.	4.
Če se to mnenje Odbora za zdravila za uporabo v humani medicini razlikuje od priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, Odbor za zdravila za uporabo v humani medicini svojemu mnenju priloži podrobno razlago znanstvenih utemeljitev za razhajanja skupaj s priporočilom.	On the basis of the opinion of the Committee for Medicinal Products for Human Use referred to in paragraph 3, the Commission shall:
4.	(a)
Na podlagi mnenja Odbora za zdravila za uporabo v humani medicini iz odstavka 3 Komisija:	adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations granted by the Member States and concerned by the procedure provided for in this section; and
(a)	(b)
sprejme odločitev, naslovljeno na države članice, o ukrepih, ki jih je treba sprejeti glede dovoljenj za promet z zdravili, ki jih izdajo države članice in ki jih zadeva postopek na podlagi tega oddelka; ter	where the opinion states that regulatory action concerning the marketing authorisation is necessary, adopt a decision to vary, suspend or revoke the marketing authorisations granted in accordance with the centralised procedure provided for in Regulation (EC) No 726/2004 and concerned by the procedure provided for in this section.
(b)	Articles 33 and 34 of this Directive shall apply to the adoption of the decision referred to in point (a) of the first subparagraph of this paragraph and to its implementation by the Member States.
kadar obstaja mnenje, da je potreben ureditveni ukrep o dovoljenju za promet z zdravilom, sprejme odločitev o spremembi, začasnem preklicu ali ukinitvi dovoljenj za promet z zdravili, izdanih v skladu s centraliziranim postopkom iz Uredbe (ES) št. 726/2004, in ki jih zadeva postopek na podlagi tega oddelka.	Article 10 of Regulation (EC) No 726/2004 shall apply to the decision referred to in point (b) of the first subparagraph of this paragraph. Where the Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of this Directive.
Za sprejetje odločitve iz točke (a) prvega pododstavka tega odstavka in za izvajanje odločitve v državah članicah se uporabljata člena 33 in 34 te direktive.	Section 3
Za odločitev iz točke (b) prvega pododstavka tega odstavka se uporablja člen 10 Uredbe (ES) št. 726/2004. Kadar Komisija sprejme tako odločitev, lahko sprejme tudi odločitev, naslovljeno na države članice na podlagi člena 127a te direktive.	Signal detection
Oddelek 3	Article 107h
Zaznavanje znakov	1.
Člen 107h	Regarding medicinal products authorised in accordance with this Directive, national competent authorities in collaboration with the Agency, shall take the following measures:
1.	(a)
Glede zdravil, odobrenih v skladu s to direktivo, pristojni nacionalni organi v sodelovanju z Agencijo sprejmejo naslednje ukrepe:	monitor the outcome of risk minimisation measures contained in risk management plans and of the conditions referred to in Articles 21a, 22 or 22a;
(a)	(b)
spremljajo izid ukrepov za zmanjšanje tveganj iz načrtov za obvladovanje tveganj in pogojev iz členov 21a, 22 ali 22a;	assess updates to the risk management system;
(b)	(c)
ocenjujejo posodobitve sistema obvladovanja tveganj;	monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the risk-benefit balance.
(c)	2.
spremljajo podatke v podatkovni bazi Eudravigilance, da ugotovijo, ali je prišlo do novih tveganj ali da so se tveganja spremenila in če vplivajo na razmerje med tveganjem in koristjo zdravila.	The Pharmacovigilance Risk Assessment Committee shall perform the initial analysis and prioritisation of signals of new risks or risks that have changed or changes to the risk-benefit balance. Where it considers that follow-up action may be necessary, the assessment of those signals and agreement on any subsequent action concerning the marketing authorisation shall be conducted in a timescale commensurate with the extent and seriousness of the issue.
2.	3.
Odbor za ocenjevanje tveganja na področju farmakovigilance opravi začetno analizo in opredeli prednostne znake o novih tveganjih ali o tveganjih, ki so se spremenila ali o spremembah razmerja med tveganjem in koristjo zdravil. Kadar meni, da so potrebni nadaljnji ukrepi, se ocena teh znakov in dogovor o vseh naknadnih ukrepih glede dovoljenja za promet z zdravilom izvedeta v časovnem okviru, ki je sorazmeren z obsegom in resnostjo zadeve.	The Agency and national competent authorities and the marketing authorisation holder shall inform each other in the event of new risks or risks that have changed or changes to the risk-benefit balance being detected.
3.	Member States shall ensure that marketing authorisation holders inform the Agency and national competent authorities in the event of new risks or risks that have changed or when changes to the risk-benefit balance have been detected.
V primeru odkritja novih ali spremenjenih tveganj ali sprememb razmerja med tveganjem in koristjo zdravila se Agencija in pristojni nacionalni organi ter imetnik dovoljenja za promet z zdravilom o tem obvestijo.	Section 4
Države članice zagotovijo, da imetniki dovoljenj za promet z zdravili obvestijo Agencijo in pristojne nacionalne organe o odkritju novih ali spremenjenih tveganj ali spremembe razmerja med tveganjem in koristjo zdravila.	Urgent Union procedure
Oddelek 4	Article 107i
Nujni postopek Unije	▼M12
Člen 107i	1.
▼M12	A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiate the procedure provided for in this section by informing the other Member States, the Agency and the Commission where:
1.	(a)
Država članica ali Komisija, kakor je ustrezno, na osnovi zadržkov, ki izhajajo iz ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, začne postopek iz tega oddelka tako, da druge države članice, Agencijo in Komisijo obvesti, kadar:	it considers suspending or revoking a marketing authorisation;
(a)	(b)
obravnava možnost začasnega odvzema ali ukinitve dovoljenja za promet;	it considers prohibiting the supply of a medicinal product;
(b)	(c)
obravnava možnost prepovedi dobav zdravila;	it considers refusing the renewal of a marketing authorisation; or
(c)	(d)
obravnava možnost zavrnitve podaljšanja dovoljenja za promet; ali	it is informed by the marketing authorisation holder that, on the basis of safety concerns, the holder has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or intends to take such action or has not applied for the renewal of a marketing authorisation.
(d)	1a.
jo imetnik dovoljenja za promet obvesti, da je imetnik dovoljenja zaradi varnostnih zadržkov prekinil dajanje zdravila v promet ali ukrepal za umik dovoljenja za promet ali to namerava storiti ali pa ni zaprosil za podaljšanje dovoljenja za promet.	A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, inform the other Member States, the Agency and the Commission where it considers that a new contraindication, a reduction in the recommended dose or a restriction to the indications of a medicinal product is necessary. The information shall outline the action considered and the reasons therefor.
1a.	Any Member State or the Commission, as appropriate, shall, when urgent action is considered necessary, initiate the procedure provided for in this section in any of the cases referred to in this paragraph.
Država članica ali Komisija, kakor je ustrezno, na osnovi zadržkov, ki izhajajo iz ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, obvesti druge države članice, Agencijo in Komisijo, kadar meni, da so potrebne nove kontraindikacije, zmanjšanje priporočenega odmerka ali omejitev indikacij zdravila. V obvestilu so opisani obravnavani ukrepi in razlogi zanje.	Where the procedure provided for in this section is not initiated, for medicinal products authorised in accordance with the procedures laid down in Chapter 4 of Title III, the case shall be brought to the attention of the coordination group.
Vsaka država članica ali Komisija, kakor je ustrezno, v katerem koli od primerov iz tega odstavka začne postopek iz tega oddelka, ko meni, da so potrebni nujni ukrepi.	Article 31 shall be applicable where the interests of the Union are involved.
Če postopek iz tega oddelka ni začet, se v primeru, ko so zdravila odobrena v skladu s postopki iz poglavja 4 naslova III, zadeva posreduje skupini za usklajevanje.	1b.
Člen 31 se uporabi, kadar so vključeni interesi Unije.	Where the procedure provided for in this section is initiated, the Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.
1b.	Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make the information that the procedure has been initiated available to marketing authorisation holders.
Če je postopek iz tega oddelka začet, Agencija preveri, ali je varnostni zadržek povezan z drugimi zdravili, ki niso zajeta v obvestilu, in ali je skupen vsem zdravilom, ki pripadajo istemu nizu ali terapevtski skupini.	▼M10
Če so zadevna zdravila odobrena v več kot eni državi članici, Agencija brez odlašanja obvesti začetnika postopka o ugotovitvah tega preverjanja, uporabijo pa se postopki iz členov 107j in 107k. Sicer pa varnostni zadržek obravnava zadevna država članica. Agencija ali država članica, kakor je primerno, obvesti imetnike dovoljenja za promet o začetku postopka.	2.
▼M10	Without prejudice to the provisions of ►M12 paragraphs 1 and 1a of this Article, ◄ and Articles 107j and 107k, a Member State may, where urgent action is necessary to protect public health, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted. It shall inform the Commission, the Agency and the other Member States no later than the following working day of the reasons for its action.
2.	3.
Brez poseganja v določbe ►M12 odstavkov 1 in 1a tega člena ◄ in členov 107j in 107k lahko država članica, če je potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno prekliče dovoljenje za promet z zdravilom in prepove uporabo zadevnega zdravila na svojem ozemlju do sprejetja dokončne odločitve. O razlogih za svoje ukrepe obvesti Komisijo, Agencijo in ostale države članice najpozneje naslednji delovni dan.	At any stage of the procedure laid down in Articles 107j to 107k, the Commission may request Member States in which the medicinal product is authorised to take temporary measures immediately.
3.	Where the scope of the procedure, as determined ►M12 in accordance with paragraphs 1 and 1a ◄ , includes medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Commission may, at any stage of the procedure initiated under this section, take temporary measures immediately in relation to those marketing authorisations.
V kateri koli fazi postopka iz členov 107j in 107k lahko Komisija zahteva, da države članice, v katerih je zdravilo odobreno, takoj sprejmejo začasne ukrepe.	4.
Kadar področje uporabe postopka, kakor je določeno ►M12 v skladu z odstavkoma 1 in 1a ◄ , vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, lahko Komisija v kateri koli fazi postopka, sproženega na podlagi tega oddelka, takoj sprejme začasne ukrepe v zvezi z navedenimi dovoljenji za promet z zdravilom.	The information referred to in this Article may relate to individual medicinal products or to a range of medicinal products or a therapeutic class.
4.	If the Agency identifies that the safety concern relates to more medicinal products than those which are covered by the information or that it is common to all medicinal products belonging to the same range or therapeutic class, it shall extend the scope of the procedure accordingly.
Obvestila iz tega člena se lahko nanašajo na eno zdravilo ali na skupino zdravil ali terapevtsko skupino.	Where the scope of the procedure initiated under this Article concerns a range of medicinal products or therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure.
Če Agencija ugotovi, da se varnostni zadržek nanaša na več zdravil, kot jih zajema obvestilo, ali na vsa zdravila, ki sodijo v navedeno skupino ali terapevtsko skupino, ustrezno razširi področje uporabe postopka.	5.
Kadar področje uporabe postopka, sproženega na podlagi tega člena, zadeva skupino zdravil ali terapevtsko skupino, so zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, ki sodijo v navedeno skupino ali terapevtsko skupino, tudi vključena v postopek.	At the time of the information referred to ►M12 in paragraphs 1 and 1a, ◄ the Member State shall make available to the Agency all relevant scientific information that it has at its disposal and any assessment by the Member State.
5.	Article 107j
V času obvestila ►M12 iz odstavkov 1 in 1a ◄ država članica Agenciji da na voljo vse zadevne znanstvene informacije, ki jih ima na voljo, ter vse ocene države članice.	1.
Člen 107j	Following receipt of the information referred to ►M12 in paragraphs 1 and 1a of Article 107i, ◄ the Agency shall publicly announce the initiation of the procedure by means of the European medicines web-portal. In parallel, Member States may publicly announce the initiation on their national medicines web-portals.
1.	The announcement shall specify the matter submitted to the Agency in accordance with Article 107i, and the medicinal products and, where applicable, the active substances concerned. It shall contain information on the right of the marketing authorisation holders, healthcare professionals and the public to submit to the Agency information relevant to the procedure and it shall state how such information may be submitted.
Po tem ko je prejela obvestilo ►M12 iz odstavkov 1 in 1a člena 107i ◄ Agencija objavi začetek postopka na evropskem spletnem portalu o zdravilih. Istočasno lahko države članice obvestijo javnost o sprožitvi postopka na svojih nacionalnih spletnih portalih o zdravilih.	2.
V objavi se navedejo zadeva, predložena v skladu s členom 107i, zadevna zdravila, in kadar je primerno, zadevne zdravilne učinkovine. Objava vsebuje informacije o pravici imetnikov dovoljenj za promet z zdravili, zdravstvenih delavcev in javnosti, da Agenciji predložijo informacije, pomembne za postopek, ter možne načine predložitve teh informacij.	The Pharmacovigilance Risk Assessment Committee shall assess the matter which has been submitted to the Agency in accordance with Article 107i. The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use and the Reference Member State for the medicinal products concerned.
2.	For the purposes of that assessment, the marketing authorisation holder may submit comments in writing.
Odbor za ocenjevanje tveganja na področju farmakovigilance oceni zadevo, ki je bila predložena Agenciji v skladu s členom 107i. Poročevalec tesno sodeluje s poročevalcem, ki ga imenujeta Odbor za zdravila za uporabo v humani medicini in referenčna država članica za zadevna zdravila.	Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern. The hearings shall be held in accordance with the modalities specified by the Agency and shall be announced by means of the European medicines web-portal. The announcement shall specify the modalities of participation.
Za namene navedene ocene lahko imetniki dovoljenja za promet z zdravilom pisno podajo svoje pripombe.	In the public hearing, due regard shall be given to the therapeutic effect of the medicinal product.
Če nujnost zadeve to dovoljuje, Odbor za ocenjevanje tveganja na področju farmakovigilance lahko opravi javno obravnavo, in če to šteje za primerno na podlagi utemeljenih razlogov, zlasti kar zadeva obseg in resnost varnostnega zadržka. Obravnave se opravijo na način, ki ga natančno določi Agencija, in se objavijo na evropskem spletnem portalu o zdravilih. V obvestilu se natančno določijo načini sodelovanja.	The Agency shall, in consultation with the parties concerned, draw up Rules of Procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No 726/2004.
Na javni obravnavi se ustrezno pozornost nameni terapevtskim učinkom zdravila.	Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.
Agencija, po posvetovanju z zainteresiranimi stranmi, določi poslovnik, ki se uporablja za organizacijo in izvedbo javnih obravnav, v skladu s členom 78 Uredbe (ES) št. 726/2004.	3.
Kadar ima imetnik dovoljenja za promet ali druga oseba, ki namerava predložiti informacije, zaupne podatke, pomembne za vsebino postopka, lahko zahteva, da te podatke predstavi Odboru za ocenjevanje tveganja na področju farmakovigilance na obravnavi, ki ni javna.	Within 60 days of the information being submitted, the Pharmacovigilance Risk Assessment Committee shall make a recommendation, stating the reasons on which it is based, having due regard to the therapeutic effect of the medicinal product. The recommendation shall mention the divergent positions and the grounds on which they are based. In the case of urgency, and on the basis of a proposal by its chairman, the Pharmacovigilance Risk Assessment Committee may agree to a shorter deadline. The recommendation shall include any or a combination of the following conclusions:
3.	(a)
V 60 dneh po predložitvi informacij Odbor za ocenjevanje tveganja na področju farmakovigilance pripravi priporočilo, v katerem navede razloge, na katerih to priporočilo temelji, ob upoštevanju terapevtskih učinkov zdravila. V priporočilu se navedejo različna stališča, vključno z njihovimi utemeljitvami. Odbor za ocenjevanje tveganja na področju farmakovigilance lahko v izrednih razmerah in na predlog svojega predsednika doseže dogovor o krajšem roku. Priporočilo vsebuje enega ali kombinacijo naslednjih sklepov:	no further evaluation or action is required at Union level;
(a)	(b)
na ravni Unije se ne zahteva nobeno nadaljnje ocenjevanje ali ukrepanje;	the marketing authorisation holder should conduct further evaluation of data together with the follow-up of the results of that evaluation;
(b)	(c)
imetnik dovoljenja za promet bi moral opraviti nadaljnje ocenjevanje podatkov skupaj z nadaljnjim spremljanjem rezultatov navedenega ocenjevanja;	the marketing authorisation holder should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study;
(c)	(d)
imetnik dovoljenja za promet bi moral financirati študijo o varnosti zdravila po pridobitvi dovoljenja za promet skupaj z nadaljnjo oceno rezultatov navedene študije;	the Member States or marketing authorisation holder should implement risk minimisation measures;
(d)	(e)
države članice ali imetnik dovoljenja za promet z zdravilom bi moral izvesti ukrepe za zmanjšanje tveganj;	the marketing authorisation should be suspended, revoked or not renewed;
(e)	(f)
dovoljenje za promet z zdravilom bi bilo treba začasno preklicati, ukiniti ali ga ne podaljšati;	the marketing authorisation should be varied.
(f)	For the purposes of point (d) of the first subparagraph, the recommendation shall specify the risk minimisation measures recommended and any conditions or restrictions to which the marketing authorisation should be made subject.
dovoljenje za promet z zdravilom bi bilo treba spremeniti.	Where, in the cases referred to in point (f) of the first subparagraph, it is recommended to change or add information in the summary of product characteristics or the labelling or package leaflet, the recommendation shall suggest the wording of such changed or added information and where in the summary of the product characteristics, labelling or package leaflet such wording should be placed.
Za namene točke (d) prvega pododstavka priporočilo določa priporočene ukrepe za zmanjšanje tveganj ter pogoje ali omejitve, ki veljajo za dovoljenje za promet z zdravilom.	Article 107k
Kadar je v primerih iz točke (f) prvega pododstavka priporočeno, da se v povzetku glavnih značilnosti zdravila, označevanju ali navodilu za uporabo spremenijo ali dodajo informacije, priporočilo predlaga besedilo takih spremenjenih ali dodanih informacij in kje v povzetku glavnih značilnosti zdravila, označevanju ali navodilu za uporabo naj bo to besedilo.	1.
Člen 107k	Where the scope of the procedure, as determined in accordance with Article 107i(4), does not include any marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and reach a position on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisation concerned, including a timetable for the implementation of the agreed position. Where an urgent adoption of the position is necessary, and on the basis of a proposal by its chairman, the coordination group may agree to a shorter deadline.
1.	2.
Kadar področje uporabe postopka, kakor je določeno v skladu s členom 107i(4) ne vključuje nobenega dovoljenja za promet z zdravilom, izdanega v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po prejemu priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči priporočilo in doseže dogovor o stališču o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet z zdravilom, vključno s časovnim razporedom za izvajanje dogovorjenega stališča. Skupina za usklajevanje lahko, kjer je potrebno nujno sprejetje stališča in na podlagi predloga svojega predsednika, doseže dogovor o krajšem roku.	If, within the coordination group, the Member States represented reach agreement on the action to be taken by consensus, the chairman shall record the agreement and send it to the marketing authorisation holder and the Member States. The Member States shall adopt necessary measures to maintain, vary, suspend, revoke or refuse renewal of the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.
2.	In the event that a variation is agreed upon, the marketing authorisation holder shall submit to the national competent authorities an appropriate application for a variation, including an updated summary of product characteristics and package leaflet within the determined timetable for implementation.
Če v okviru skupine za usklajevanje zastopane države članice soglasno dosežejo dogovor o ukrepih, ki se sprejmejo, predsednik zabeleži strinjanje in to posreduje imetniku dovoljenja za promet z zdravilom in državam članicam. Države članice sprejmejo ustrezne ukrepe, da ohranijo, spremenijo, začasno prekličejo, ukinejo ali zavrnejo podaljšanje zadevnega dovoljenja za promet z zdravilom v skladu s časovnim razporedom za izvajanje, določenim v dogovoru.	If an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34. However, by way of derogation from Article 34(1), the procedure referred to in Article 121(2) shall apply.
V primeru dogovora o spremembi, imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži ustrezno vlogo za spremembo, vključno s posodobljenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo v časovnem roku določenem za izvajanje.	Where the agreement reached by the Member States represented within the coordination group or the position of the majority of the Member States represented within the coordination group differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če dogovora ni mogoče doseči soglasno, se stališče večine zastopanih držav članic v okviru skupine za usklajevanje posreduje Komisiji, ki uporabi postopek, določen v členih 33 in 34. Vendar se z odstopanjem od člena 34(1) uporablja postopek iz člena 121(2).	3.
Če dogovor, ki so ga v skupini za usklajevanje dosegle zastopane države članice, ali stališče večine zastopanih držav članic v skupini za usklajevanje ni v skladu s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, skupina za usklajevanje temu dogovoru ali stališču večine skupaj s priporočilom priloži podrobno razlago znanstvenih utemeljitev za razhajanja.	Where the scope of the procedure, as determined in accordance with Article 107i(4), includes at least one marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and adopt an opinion on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisations concerned. Where an urgent adoption of the opinion is necessary, and on the basis of a proposal by its chairman, the Committee for Medicinal Products for Human Use may agree to a shorter deadline.
3.	Where the opinion of the Committee for Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences together with the recommendation.
Kadar področje uporabe postopka, kakor je določeno v členu 107i(4), vključuje vsaj eno dovoljenje za promet z zdravilom, izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči priporočilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet z zdravilom. Odbor za zdravila za uporabo v humani medicini lahko, kjer je potrebno nujno sprejetje mnenja in na podlagi predloga svojega predsednika, doseže dogovor o krajšem roku.	4.
Če mnenje Odbora za zdravila za uporabo v humani medicini ni skladno s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, Odbor za zdravila za uporabo v humani medicini svojemu mnenju skupaj s priporočilom priloži podrobno znanstveno razlago za razhajanja.	On the basis of the opinion of the Committee for Medicinal Products for Human Use referred to in paragraph 3, the Commission shall:
4.	(a)
Na podlagi mnenja Odbora za zdravila za uporabo v humani medicini iz odstavka 3 Komisija:	adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations that are granted by the Member States and that are subject to the procedure provided for in this section; and
(a)	(b)
sprejme odločitev, naslovljeno na države članice, o ukrepih, ki jih je treba sprejeti glede dovoljenj za promet z zdravili, ki so jih izdale države članice in ob upoštevanju postopka iz tega oddelka; ter	where the opinion is that regulatory action is necessary, adopt a decision to vary, suspend, revoke or refuse renewal of the marketing authorisations granted in accordance with Regulation (EC) No 726/2004 and subject to the procedure provided for in this section.
(b)	Articles 33 and 34 of this Directive shall apply to the adoption of the decision referred to in point (a) of the first subparagraph of this paragraph and to its implementation by the Member States. However, by way of derogation from Article 34(1) of this Directive, the procedure referred to in Article 121(2) thereof shall apply.
kadar obstaja mnenje, da je potreben ureditveni ukrep, sprejme odločitev o spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja dovoljenj za promet z zdravili, izdanih v skladu z Uredbo (ES) št. 726/2004, in ob upoštevanju postopka iz tega oddelka.	Article 10 of Regulation (EC) No 726/2004 shall apply to the decision referred to in point (b) of the first subparagraph of this paragraph. However, by way of derogation from Article 10(2) of that Regulation, the procedure referred to in Article 87(2) thereof shall apply. Where the Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of this Directive.
Za sprejetje odločitve iz točke (a) prvega pododstavka tega odstavka in za izvajanje odločitve v državah članicah se uporabljata člena 33 in 34 te direktive. Vendar se z odstopanjem od člena 34(1) te direktive uporablja postopek iz člena 121(2).	Section 5
Za odločitev iz točke (b) prvega pododstavka tega odstavka se uporablja člen 10 Uredbe (ES) št. 726/2004. Vendar se z odstopanjem od člena 10(2) navedene uredbe uporablja postopek iz člena 87(2) navedene uredbe. Kadar Komisija sprejme tako odločitev, lahko sprejme tudi odločitev, naslovljeno na države članice na podlagi člena 127a te direktive.	Publication of assessments
Oddelek 5	Article 107l
Objava ocen	The Agency shall make public the final assessment conclusions, recommendations, opinions and decisions referred to in Articles 107b to 107k by means of the European medicines web-portal.
Člen 107l	CHAPTER 4
Agencija objavi sklepe, priporočila, mnenja in odločitve končnega ocenjevanja iz členov 107b do 107k na evropskem spletnem portalu o zdravilih.	Supervision of post-authorisation safety studies
POGLAVJE 4	Article 107m
Nadzor študij o varnosti zdravila po pridobitvi dovoljenja za promet	1.
Člen 107m	This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals.
1.	2.
To poglavje se uporablja za neintervencijske študije varnosti po pridobitvi dovoljenja za promet, ki jih prostovoljno ali na zahtevo v skladu s členom 21a ali 22a začne, upravlja ali financira imetnik dovoljenja za promet z zdravilom in ki vključujejo zbiranje varnostnih podatkov od bolnikov ali zdravstvenih delavcev.	This Chapter is without prejudice to national and Union requirements for ensuring the well-being and rights of participants in non-interventional post-authorisation safety studies.
2.	3.
To poglavje ne posega v nacionalne zahteve in zahteve Unije po zagotavljanju dobrega počutja in pravic udeležencev v neintervencijskih študijah varnosti po pridobitvi dovoljenja za promet.	The studies shall not be performed where the act of conducting the study promotes the use of a medicinal product.
3.	4.
Študije se ne izvedejo, kadar izvajanje študije spodbuja uporabo zdravila.	Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be restricted to the compensation for time and expenses incurred.
4.	5.
Plačila zdravstvenim delavcem za sodelovanje pri neintervencijskih študijah varnosti po pridobitvi dovoljenja za promet so omejena na nadomestilo za čas in nastale stroške.	The national competent authority may require the marketing authorisation holder to submit the protocol and the progress reports to the competent authorities of the Member States in which the study is conducted.
5.	6.
Pristojni nacionalni organ lahko od imetnika dovoljenja za promet z zdravilom zahteva, da pristojnim organom držav članic, v katerih se izvaja študija, predloži protokol in poročila o napredku.	The marketing authorisation holder shall send the final report to the competent authorities of the Member States in which the study was conducted within 12 months of the end of data collection.
6.	7.
Imetnik dovoljenja za promet z zdravilom pošlje končno poročilo pristojnim organom držav članic, v katerih se je izvajala študija, v 12 mesecih po koncu zbiranja podatkov.	While a study is being conducted, the marketing authorisation holder shall monitor the data generated and consider its implications for the risk-benefit balance of the medicinal product concerned.
7.	Any new information which might influence the evaluation of the risk-benefit balance of the medicinal product shall be communicated to the competent authorities of the Member State in which the medicinal product has been authorised in accordance with Article 23.
Med izvajanjem študije imetnik dovoljenja za promet z zdravilom spremlja zbrane podatke in preuči njihove posledice za razmerje med tveganjem in koristjo zadevnega zdravila.	The obligation laid down in the second subparagraph is without prejudice to the information on the results of studies that the marketing authorisation holder shall make available by means of the periodic safety update reports as laid down in Article 107b.
Vse nove informacije, ki bi lahko vplivale na oceno razmerja med tveganjem in koristjo zdravila, se sporočijo pristojnim organom držav članic, kjer je zdravilo odobreno v skladu s členom 23.	8.
Obveznost iz drugega pododstavka ne posega v informacije o rezultatih študij, ki jih imetnik dovoljenja za promet z zdravilom da na voljo z rednimi posodobljenimi poročili o varnosti zdravila, kot je določeno v členu 107b.	Articles 107n to 107q shall apply exclusively to studies referred to in paragraph 1 which are conducted pursuant to an obligation imposed in accordance with Articles 21a or 22a.
8.	Article 107n
Členi 107n do 107q se uporabljajo izključno za študije iz odstavka 1, ki se izvedejo na podlagi obveznosti, naložene v skladu s členom 21a ali 22a.	1.
Člen 107n	Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a. For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted.
1.	2.
Pred izvedbo študije imetnik dovoljenja za promet z zdravilom predloži osnutek protokola Odboru za ocenjevanje tveganja na področju farmakovigilance, razen za študije, ki bodo izvedene samo v eni državi članici, ki študijo zahteva v skladu s členom 22a. Za takšne študije se od imetnika dovoljenja za promet z zdravilom zahteva, da osnutek protokola predloži pristojnemu nacionalnemu organu države članice, v kateri se izvaja študija.	Within 60 days of the submission of the draft protocol the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall issue:
2.	(a)
V 60 dneh po predložitvi osnutka protokola pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance izda:	a letter endorsing the draft protocol;
(a)	(b)
pismo o odobritvi osnutka protokola;	a letter of objection, which shall set out in detail the grounds for the objection, in any of the following cases:
(b)	(i)
pismo o ugovoru, ki temelji na podrobnih razlogih za ugovor, kadar:	it considers that the conduct of the study promotes the use of a medicinal product;
(i)	(ii)
meni, da izvajanje študije spodbuja uporabo zdravila;	it considers that the design of the study does not fulfil the study objectives; or
(ii)	(c)
meni, da zasnova študije ne izpolnjuje ciljev študije; ali	a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Directive 2001/20/EC.
(c)	3.
pismo, v katerem uradno obvešča imetnika dovoljenja za promet z zdravilom, da gre za klinično preskušanje, ki sodi v področje uporabe Direktive 2001/20/ES.	The study may commence only when the written endorsement from the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued.
3.	Where a letter of endorsement as referred to in paragraph 2(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol.
Študija se lahko začne samo s pisno odobritvijo pristojnega nacionalnega organa ali Odbora za ocenjevanje tveganja na področju farmakovigilance.	Article 107o
Kadar je bilo izdano pismo o odobritvi iz točke (a) odstavka 2, imetnik dovoljenja za promet z zdravilom posreduje protokol pristojnim organom držav članic, v katerih je načrtovana izvedba študije, nato pa lahko začne izvajati študijo v skladu z odobrenim protokolom.	After a study has been commenced, any substantial amendments to the protocol shall be submitted, before their implementation, to the national competent authority or to the Pharmacovigilance Risk Assessment Committee, as appropriate. The national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall assess the amendments and inform the marketing authorisation holder of its endorsement or objection. Where applicable, the marketing authorisation holder shall inform Member States in which the study is conducted.
Člen 107o	Article 107p
Po začetku študije se vsaka vsebinska sprememba protokola, preden se začne izvajati, predloži pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance. Pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance oceni spremembe in obvesti imetnika dovoljenja za promet z zdravilom o svoji odobritvi ali ugovoru. Imetnik dovoljenja za promet z zdravilom, kadar je to primerno, obvesti države članice, kjer se študija izvaja.	1.
Člen 107p	Upon completion of the study, a final study report shall be submitted to the national competent authority or the Pharmacovigilance Risk Assessment Committee within 12 months of the end of data collection unless a written waiver has been granted by the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate.
1.	2.
Po končani študiji se zaključna poročila o študiji predložijo pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance v 12 mesecih po koncu zbiranja podatkov, razen če se pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance temu pisno odpove.	The marketing authorisation holder shall evaluate whether the results of the study have an impact on the marketing authorisation and shall, if necessary, submit to the national competent authorities an application to vary the marketing authorisation.
2.	3.
Imetnik dovoljenja za promet z zdravilom oceni, ali rezultati študije vplivajo na dovoljenje za promet z zdravilom in kadar je potrebno, pristojnim nacionalnim organom predloži vlogo za spremembo dovoljenja za promet z zdravilom.	Together with the final study report, the marketing authorisation holder shall electronically submit an abstract of the study results to the national competent authority or the Pharmacovigilance Risk Assessment Committee.
3.	Article 107q
Imetnik dovoljenja za promet z zdravilom skupaj z zaključnim poročilom o študiji pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance elektronsko predloži izvleček študije.	1.
Člen 107q	Based on the results of the study and after consultation of the marketing authorisation holder, the Pharmacovigilance Risk Assessment Committee may make recommendations concerning the marketing authorisation, stating the reasons on which they are based. The recommendations shall mention the divergent positions and the grounds on which they are based.
1.	2.
Odbor za ocenjevanje tveganja na področju farmakovigilance na podlagi rezultatov študije in po posvetovanju z imetnikom dovoljenja za promet z zdravilom lahko izdela priporočilo glede dovoljenja za promet, v katerem navede razloge, na katerih to priporočilo temelji. V priporočilu se navedejo različna stališča, vključno z njihovimi utemeljitvami.	When recommendations for the variation, suspension or revocation of the marketing authorisation are made for a medicinal product authorised by the Member States pursuant to this Directive, the Member States represented within the coordination group shall agree a position on the matter taking into account the recommendation referred to in paragraph 1 and including a timetable for the implementation of the agreed position.
2.	If, within the coordination group, the Member States represented reach agreement on the action to be taken by consensus, the chairman shall record the agreement and send it to the marketing authorisation holder and the Member States. The Member States shall adopt necessary measures to vary, suspend or revoke the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.
V primeru priporočil za spremembo, začasni preklic ali ukinitev dovoljenja za promet za zdravilo, ki ga odobrijo države članice na podlagi te direktive, države članice zastopane v skupini za usklajevanje sprejmejo stališče o zadevi ob upoštevanju priporočila iz odstavka 1, vključno s časovnim razporedom za izvajanje sprejetega stališča.	In the event that a variation is agreed upon, the marketing authorisation holder shall submit to the national competent authorities an appropriate application for a variation, including an updated summary of product characteristics and package leaflet within the determined timetable for implementation.
Če v okviru skupine za usklajevanje zastopane države članice soglasno dosežejo dogovor o ukrepih, ki se sprejmejo, predsednik zabeleži strinjanje in to posreduje imetniku dovoljenja za promet z zdravilom in državam članicam. Države članice sprejmejo ustrezne ukrepe, da spremenijo, začasno prekličejo ali ukinejo zadevno dovoljenje za promet z zdravilom v skladu s časovnim razporedom za izvajanje, določenim v dogovoru.	The agreement shall be made public on the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
V primeru dogovora o spremembi, imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži ustrezno vlogo za spremembo, vključno s posodobljenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo v časovnem roku določenem za uveljavitev.	If an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 33 and 34.
Dogovor se objavi na evropskem spletnem portalu o zdravilih, vzpostavljenem v skladu s členom 26 Uredbe (ES) št. 726/2004.	Where the agreement reached by the Member States represented within the coordination group or the position of the majority of Member States differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če dogovora ni mogoče doseči soglasno, se stališče večine zastopanih držav članic v okviru skupine za usklajevanje posreduje Komisiji, ki uporabi postopek, določen v členih 33 in 34.	CHAPTER 5
Če dogovor, ki so ga v skupini za usklajevanje dosegle zastopane države članice, ali stališče večine držav članic ni v skladu s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, skupina za usklajevanje temu dogovoru ali stališču večine skupaj s priporočilom priloži podrobno razlago znanstvenih utemeljitev za razhajanja.	Implementation, Delegation and Guidance
POGLAVJE 5	Article 108
Izvajanje, prenos pooblastil in smernice	In order to harmonise the performance of the pharmacovigilance activities provided for in this Directive, the Commission shall adopt implementing measures in the following areas for which pharmacovigilance activities are provided for in Article 8(3), and in Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p:
Člen 108	(a)
Da bi uskladili opravljanje dejavnosti na področju farmakovigilance iz te direktive, Komisija sprejme izvedbene ukrepe na naslednjih področjih za katera so predvidene dejavnosti farmakovigilance, ki so določena v členih 8(3) in členih 101, 104, 104a, 107, 107a, 107b, 107h, 107n in 107p:	the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;
(a)	(b)
vsebina in vzdrževanje glavnega dosjeja o sistemu farmakovigilance, ki ga opravlja imetnik dovoljenja za promet z zdravilom;	the minimum requirements for the quality system for the performance of pharmacovigilance activities by the national competent authorities and the marketing authorisation holder;
(b)	(c)
minimalne zahteve za sistem kakovosti za izvajanje dejavnosti na področju farmakovigilance s strani pristojnih nacionalnih organov in imetnikov dovoljenj za promet z zdravili;	the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
(c)	(d)
uporaba mednarodno dogovorjene terminologije, oblik in standardov za izvajanje dejavnosti farmakovigilance;	the minimum requirements for the monitoring of data in the Eudravigilance database to determine whether there are new risks or whether risks have changed;
(d)	(e)
minimalne zahteve za spremljanje podatkov v podatkovni bazi Eudravigilance, da se ugotovi, ali je prišlo do novih tveganj ali da so se tveganja spremenila;	the format and content of the electronic transmission of suspected adverse reactions by Member States and the marketing authorisation holder;
(e)	(f)
oblika in vsebina elektronskega prenosa obvestil o domnevnih neželenih učinkih s strani držav članic in imetnikov dovoljenj za promet z zdravili;	the format and content of electronic periodic safety update reports and risk management plans;
(f)	(g)
oblika in vsebina elektronskih rednih posodobljenih poročil o varnosti zdravila in načrtov za obvladovanje tveganj;	the format of protocols, abstracts and final study reports for the post-authorisation safety studies.
(g)	Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 121(2).
oblika protokolov, izvlečkov in zaključnih poročil za študije o varnosti zdravila po pridobitvi dovoljenja za promet.	Article 108a
V navedenih ukrepih se upošteva delo mednarodnega usklajevanja, opravljeno na področju farmakovigilance in se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek. Ti ukrepi se sprejmejo v skladu s postopkom iz člena 121(2).	In order to facilitate the performance of pharmacovigilance activities within the Union, the Agency shall, in cooperation with competent authorities and other interested parties, draw up:
Člen 108a	(a)
Za spodbujanje dejavnosti na področju farmakovigilance v Uniji, Agencija v sodelovanju s pristojnimi organi in drugimi zainteresiranimi stranmi oblikuje:	guidance on good pharmacovigilance practices for both competent authorities and marketing authorisation holders;
(a)	(b)
smernice o dobri praksi na področju farmakovigilance za pristojne organe in imetnike dovoljenj za promet z zdravili;	scientific guidance on post-authorisation efficacy studies.
(b)	Article 108b
znanstvene smernice o študijah učinkovitosti po pridobitvi dovoljenja za promet z zdravilom.	The Commission shall make public a report on the performance of pharmacovigilance tasks by the Member States on 21 July 2015 at the latest and then every 3 years thereafter.
Člen 108b	▼B
Komisija objavi poročilo o tem, kako države članice izvajajo naloge farmakovigilance najpozneje 21. julija 2015 in nato vsaka tri leta.	TITLE X
▼B	SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA
NASLOV X	▼M1
POSEBNE DOLOČBE O ZDRAVILIH, PRIDOBLJENIH IZ ČLOVEŠKE KRVI IN PLAZME	Article 109
▼M1	For the collection and testing of human blood and human plasma, Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC ( 14 ) shall apply.
Člen 109	▼B
Za zbiranje in testiranje človeške krvi in človeške plazme se uporablja Direktiva 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, testiranje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES ( 14 ).	Article 110
▼B	Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations. They shall notify the Commission of such measures.
Člen 110	TITLE XI
Države članice sprejmejo potrebne ukrepe za spodbujanje samozadostnosti Skupnosti pri oskrbi s človeško krvjo ali človeško plazmo. V ta namen spodbujajo prostovoljno, neplačano darovanje krvi in plazme ter sprejmejo potrebne ukrepe za razvoj proizvodnje in uporabe zdravil, pridobljenih iz človeške krvi ali človeške plazme, ki prihaja iz prostovoljnega in neplačanega darovanja. O takih ukrepih obvestijo Komisijo.	SUPERVISION AND SANCTIONS
NASLOV XI	Article 111
NADZOR IN SANKCIJE	▼M11
Člen 111	1.
▼M11	The competent authority of the Member State concerned shall, in cooperation with the Agency, ensure that the legal requirements governing medicinal products are complied with, by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples. This cooperation shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted. Member States and the Agency shall cooperate in the coordination of inspections in third countries. The inspections shall include but not be limited to the ones mentioned in paragraphs 1a to 1f.
1.	1a.
Pristojni organ zadevne države članice v sodelovanju z Agencijo zagotovi z inšpekcijskimi pregledi, po potrebi nenapovedanimi, ter, kadar je to primerno, s prošnjo za testiranje vzorcev, naslovljeno na Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, pooblaščen za ta namen, da so pravne zahteve, ki urejajo področje zdravil, izpolnjene. To sodelovanje zajema izmenjavo informacij z Agencijo tako o načrtovanih kot o izvedenih inšpekcijskih pregledih. Države članice in Agencija sodelujejo pri usklajevanju inšpekcijskih pregledov v tretjih državah. Ti pregledi zajemajo tudi preglede iz odstavkov 1a do 1f, vendar niso omejeni samo nanje.	Manufacturers, located in the Union or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections.
1a.	1b.
Za proizvajalce zdravil s sedežem v Uniji ali v tretjih državah in trgovce na debelo se inšpekcijski pregledi izvajajo redno.	The competent authority of the Member State concerned shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located on its territory, and effective follow-up thereof.
1b.	Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Directive, including the principles and guidelines of good manufacturing practice and good distribution practices referred to in point (f) of Article 46 and in Article 47, the competent authority may carry out inspections at the premises of:
Pristojni organ zadevne države članice ima nadzorni sistem, ki glede na tveganje vključuje ustrezno pogoste inšpekcijske preglede v prostorih proizvajalcev, uvoznikov ali distributerjev zdravilnih učinkovin na njihovem ozemlju, in učinkovito nadaljnje spremljanje.	(a)
Kadar meni, da obstaja utemeljen sum neupoštevanja pravnih zahtev iz te direktive, vključno načel in smernic dobre proizvodne prakse in dobrih distribucijskih praks iz točke (f) člena 46 in iz člena 47, lahko pristojni organ izvede inšpekcijske preglede v prostorih:	manufacturers or distributors of active substances located in third countries;
(a)	(b)
proizvajalcev ali distributerjev zdravilnih učinkovin s sedežem v tretjih državah;	manufacturers or importers of excipients.
(b)	1c.
proizvajalcev ali uvoznikov pomožnih snovi.	Inspections referred to in paragraphs 1a and 1b may also be carried out in the Union and in third countries at the request of a Member State, the Commission or the Agency.
1c.	1d.
Inšpekcijski pregledi iz odstavkov 1a in 1b se lahko v Uniji in tretjih državah izvedejo tudi na zahtevo države članice, Komisije ali Agencije.	Inspections may also take place at the premises of marketing authorisation holders and of brokers of medicinal products.
1d.	1e.
Inšpekcijski pregledi se lahko opravijo v prostorih imetnikov dovoljenja za promet in posrednikov zdravil.	In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body of the nomenclatures and the quality norms within the meaning of the Convention relating to the elaboration of the European Pharmacopoeia (the European Directorate for the Quality of Medicines and Healthcare) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph.
1e.	1f.
Da se preveri, ali so podatki, predloženi za pridobitev certifikata ustreznosti, v skladu z monografijami Evropske farmakopeje, lahko organ za standardizacijo nomenklature in kakovostnih norm v smislu konvencije o razčlenitvi Evropske farmakopeje (Evropska direkcija za kakovost zdravil in zdravstva) zaprosi Komisijo ali Agencijo, naj zahteva tak inšpekcijski pregled, kadar zadevno vhodno snov obravnava monografija Evropske farmakopeje.	The competent authority of the Member State concerned may carry out inspections of starting material manufacturers at the specific request of the manufacturer.
1f.	1g.
Pristojni organ zadevne države članice lahko opravi inšpekcijske preglede pri proizvajalcih vhodnih snovi na posebno zahtevo posameznega proizvajalca.	Inspections shall be carried out by officials representing the competent authority who shall be empowered to:
1g.	(a)
Inšpekcijske preglede opravljajo uradne osebe, ki zastopajo pristojni organ in so pooblaščene za:	inspect the manufacturing or commercial establishments of manufacturers of medicinal products, of active substances or of excipients, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20;
(a)	(b)
inšpekcijski pregled proizvodnih ali poslovnih zgradb proizvajalcev zdravil, zdravilnih učinkovin ali pomožnih snovi in vseh laboratorijev, ki jih imetnik dovoljenja za proizvodnjo uporablja za izvajanje kontrole v skladu s členom 20;	take samples including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by a Member State;
(b)	(c)
jemanje vzorcev, tudi za neodvisne preskuse, ki jih opravlja Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, ki ga za ta namen določi država članica;	examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 placing restrictions on these powers with regard to the description of the manufacturing method;
(c)	(d)
pregled vseh dokumentov v zvezi s predmetom inšpekcijskega pregleda, ob upoštevanju določb, ki so bile v državah članicah v veljavi na dan 21. maja 1975 in ki omejujejo ta pooblastila glede na opis proizvodnega postopka;	inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX.
(d)	1h.
pregled prostorov, evidenc, dokumentov in glavne dokumentacije sistema farmakovigilance, ki jih imetnik dovoljenja za promet ali druga podjetja, ki jih imetnik uporablja, uporabljajo za izvajanje dejavnosti, opisanih v naslovu IX.	Inspections shall be carried out in accordance with the guidelines referred to in Article 111a.
1h.	▼B
Inšpekcijski pregledi se opravljajo v skladu s smernicami iz člena 111a.	2.
▼B	Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency.
2.	▼M11
Države članice ustrezno ukrepajo, da zagotovijo, da se proizvodni procesi, uporabljeni pri proizvodnji imunoloških zdravil, primerno validirajo in da se dosega konsistentnost med serijami.	3.
▼M11	After every inspection as referred to in paragraph 1, the competent authority shall report on whether the inspected entity complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in Articles 47 and 84, as applicable, or on whether the marketing authorisation holder complies with the requirements laid down in Title IX.
3.	The competent authority which carried out the inspection shall communicate the content of those reports to the inspected entity.
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali pregledani subjekt upošteva načela in smernice dobre proizvodne prakse in dobrih distribucijskih praks iz členov 47 in 84, kot je primerno, in ali imetnik dovoljenja za promet izpolnjuje zahteve, določene v naslovu IX.	Before adopting the report, the competent authority shall give the inspected entity concerned the opportunity to submit comments.
Pristojni organ, ki je opravil inšpekcijski pregled, vsebino navedenih poročil pošlje pregledanemu subjektu.	4.
Pred sprejetjem poročila pristojni organ zadevnemu pregledanemu subjektu omogoči, da predloži pripombe.	Without prejudice to any arrangements which may have been concluded between the Union and third countries, a Member State, the Commission or the Agency may require a manufacturer established in a third country to submit to an inspection as referred to in this Article.
4.	5.
Brez poseganja v dogovore, ki bi utegnili biti sklenjeni med Unijo in tretjimi državami, lahko država članica, Komisija ali Agencija od proizvajalca s sedežem v tretji državi zahteva, da se pri njem opravi inšpekcijski pregled iz tega člena.	Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or good distribution practices shall, when applicable, be issued to the inspected entity if the outcome of the inspection shows that it complies with the principles and guidelines of good manufacturing practice or good distribution practices as provided for by Union legislation.
5.	If inspections are performed as part of the certification procedure for the monographs of the European Pharmacopoeia, a certificate shall be drawn up.
V 90 dneh od inšpekcijskega pregleda iz odstavka 1 se pregledanemu subjektu, kadar je to ustrezno, izda certifikat dobre proizvodne prakse ali dobrih distribucijskih praks, če rezultat inšpekcijskega pregleda pokaže, da upošteva načela in smernice dobre proizvodne prakse ali dobrih distribucijskih praks, kakor so določene v zakonodaji Unije.	6.
Če se inšpekcijski pregledi opravijo kot del postopka za izdajo certifikata ustreznosti za monografije Evropske farmakopeje, se pripravi certifikat.	Member States shall enter the certificates of good manufacturing practice and good distribution practices which they issue in a Union database managed by the Agency on behalf of the Union. Pursuant to Article 52a(7), Member States shall also enter information in that database regarding the registration of importers, manufacturers and distributors of active substances. The database shall be publicly accessible.
6.	▼M10
Države članice vnesejo certifikate dobre proizvodne prakse in dobrih distribucijskih praks, ki jih izdajo, v podatkovno bazo Unije, ki jo v njenem imenu upravlja Agencija. V skladu s členom 52a(7) države članice v to podatkovno bazo vnesejo tudi informacije o registraciji uvoznikov, proizvajalcev in distributerjev zdravilnih učinkovin. Podatkovna baza je javno dostopna.	7.
▼M10	If the outcome of the inspection as referred to in points (a), (b) and (c) of ►M11 paragraph 1g ◄ or the outcome of an inspection of a distributor of medicinal products or active substances or a manufacturer of excipients ►M11 ————— ◄ is that the inspected entity does not comply with the legal requirements and/or the principles and guidelines of good manufacturing practice or good distribution practices as provided for by Union law, the information shall be entered in the Union database as provided for in paragraph 6.
7.	▼M10
Če rezultat inšpekcijskega pregleda iz točk (a), (b) in (c) ►M11 odstavka 1g ◄ ali rezultat inšpekcijskega pregleda pri distributerju zdravil ali zdravilnih učinkovin ali pri izdelovalcu pomožnih snovi, ►M11 ————— ◄ pokaže, da pregledan subjekt ne izpolnjuje pravnih zahtev in/ali načel in smernic dobre proizvodne prakse ali dobre distribucijske prakse iz zakonodaje Unije, se te informacije vnesejo v podatkovno bazo Unije, kot določa odstavek 6.	8.
▼M10	If the outcome of the inspection referred to in ►M11 point (d) of paragraph 1g ◄ is that the marketing authorisation holder does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file and with Title IX, the competent authority of the Member State concerned shall bring the deficiencies to the attention of the marketing authorisation holder and give him the opportunity to submit comments.
8.	In such case the Member State concerned shall inform the other Member States, the Agency and the Commission.
Če rezultat inšpekcijskega pregleda iz ►M11 točke (d) odstavka 1g ◄ pokaže, da imetnik dovoljenja za promet z zdravilom ne ravna v skladu s sistemom farmakovigilance, kot je opisano v glavnem dosjeju o sistemu farmakovigilance in naslovom IX, pristojni organ zadevne države članice imetnika dovoljenja za promet z zdravilom opozori na pomanjkljivosti in mu da možnost, da predloži pripombe.	Where appropriate, the Member State concerned shall take the necessary measures to ensure that a marketing authorisation holder is subject to effective, proportionate and dissuasive penalties.
V takem primeru zadevna država članica obvesti druge države članice, Agencijo in Komisijo.	▼M11
Kadar je primerno, zadevna država članica sprejme potrebne ukrepe za zagotovitev, da za imetnika dovoljenja za promet veljajo učinkovite, sorazmerne in odvračilne kazni.	Article 111a
▼M11	The Commission shall adopt detailed guidelines laying down the principles applicable to inspections referred to in Article 111.
Člen 111a	Member States shall, in cooperation with the Agency, establish the form and content of the authorisation referred to in Articles 40(1) and 77(1), of the reports referred to in Article 111(3), of the certificates of good manufacturing practice and of the certificates of good distribution practices referred to in Article 111(5).
Komisija sprejme podrobne smernice, v katerih so določena načela, ki se uporabljajo za inšpekcijske preglede iz člena 111.	Article 111b
Države članice v sodelovanju z Agencijo določijo obliko in vsebino dovoljenja iz člena 40(1) in člena 77(1), poročil iz člena 111(3), certifikatov dobre proizvodne prakse in dobrih distribucijskih praks iz člena 111(5).	1.
Člen 111b	At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union. If the assessment confirms such equivalence, the Commission shall adopt a decision to include the third country in a list. The assessment shall take the form of a review of relevant documentation and, unless arrangements as referred to in Article 51(2) of this Directive are in place that cover this area of activity, that assessment shall include an on-site review of the third country’s regulatory system and, if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances. In the assessment particular account shall be taken of:
1.	(a)
Komisija na zahtevo tretje države oceni, ali ureditveni okvir te države, ki velja za zdravilne učinkovine, ki se izvozijo v Unijo, ter zadevni nadzor in dejavnosti izvrševanja zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Uniji. Če ocena potrdi enakovrednost, Komisija sprejme odločitev o uvrstitvi tretje države na seznam. Ocena predstavlja pregled zadevne dokumentacije in, razen kadar obstajajo dogovori iz člena 51(2) te direktive, ki zajemajo to področje dejavnosti, ta ocena zajema tudi pregled na kraju samem regulativnega sistema tretje države, po potrebi pa tudi opazovan inšpekcijski pregled enega ali več proizvodnih mest za izdelavo zdravilnih učinkovin v tretji državi članici. Pri tej oceni se upoštevajo predvsem:	the country’s rules for good manufacturing practice;
(a)	(b)
pravila države o dobri proizvodni praksi;	the regularity of inspections to verify compliance with good manufacturing practice;
(b)	(c)
rednost inšpekcijskih pregledov, da se preveri upoštevanje dobre proizvodne prakse;	the effectiveness of enforcement of good manufacturing practice;
(c)	(d)
učinkovitost izvrševanja dobre proizvodne prakse;	the regularity and rapidity of information provided by the third country relating to non-compliant producers of active substances.
(d)	2.
rednost in hitrost tretjih držav pri pošiljanju informacij o neskladnih proizvajalcih zdravilnih učinkovin.	The Commission shall adopt the necessary implementing acts to apply the requirements set out in points (a) to (d) of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).
2.	3.
Komisija sprejme potrebne izvedbene akte za uporabo zahtev iz točk (a) do (d) odstavka 1 tega člena. Ti izvedbeni akti se sprejmejo v skladu s postopkom iz člena 121(2).	The Commission shall verify regularly whether the conditions laid down in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been included in the list referred to in paragraph 1.
3.	4.
Komisija redno preverja, ali so izpolnjeni pogoji iz odstavka 1. Prvo preverjanje se opravi najpozneje 3 leta po uvrstitvi države na seznam iz odstavka 1.	The Commission shall perform the assessment and verification referred to in paragraphs 1 and 3 in cooperation with the Agency and the competent authorities of the Member States.
4.	▼M16
Komisija izvede oceno in preverjanje iz odstavkov 1 in 3 v sodelovanju z Agencijo in pristojnimi organi držav članic.	Article 111c
▼M16	1.
Člen 111c	The Commission shall continuously monitor developments in the United Kingdom that could affect the level of protection regarding the regulatory functions referred to in Article 8(2a) and (2b), Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3) and Article 126c that are carried out in parts of the United Kingdom other than Northern Ireland taking into account, in particular, the following elements:
1.	(a)
Komisija stalno spremlja razvoj dogodkov v Združenem kraljestvu, ki bi lahko vplivali na raven varstva v zvezi z regulativnimi funkcijami iz člena 8(2a) in (2b), člena 20, drugi odstavek, člena 40(1a) in (3a), člena 48(3), člena 104(3) in člena 126c, ki se izvajajo v delih Združenega kraljestva razen Severne Irske, ob upoštevanju zlasti naslednjih elementov:	the rules governing the granting of marketing authorisations, the obligations of the marketing authorisation holder, the granting of manufacturing authorisations, the obligations of the manufacturing authorisation holder, the qualified persons and their obligations, quality control testing, batch release and pharmacovigilance as laid down in United Kingdom law;
(a)	(b)
pravil, ki urejajo izdajo dovoljenj za promet, obveznosti imetnika dovoljenja za promet, izdajo dovoljenj za proizvodnjo, obveznosti imetnika dovoljenja za proizvodnjo, usposobljene osebe in njihove obveznosti, preskušanje z namenom kontrole kakovosti, sprostitev serije in farmakovigilanco, kot je določeno v pravu Združenega kraljestva;	whether the competent authorities of the United Kingdom ensure the effective enforcement within their territory of the rules referred to in point (a), by means of, inter alia, inspections and audits of marketing authorisation holders, manufacturing authorisation holders and wholesale distributors located in their territories, and on-the-spot checks at their premises regarding the exercise of the regulatory functions referred to in point (a).
(b)	2.
dejstva, ali pristojni organi Združenega kraljestva na svojem ozemlju zagotovijo učinkovito izvrševanje pravil iz točke (a), med drugim z inšpekcijskimi pregledi in revizijami imetnikov dovoljenj za promet, imetnikov dovoljenj za proizvodnjo in trgovcev na debelo, ki se nahajajo na njihovih ozemljih, ter pregledi na kraju samem v njihovih prostorih v zvezi z izvajanjem regulativnih funkcij iz točke (a).	Where the Commission finds that the level of protection of public health ensured by the United Kingdom through rules governing the production, distribution and use of medicinal products as well as the effective enforcement of those rules is no longer essentially equivalent to that guaranteed within the Union, or where sufficient information is not available to the Commission to enable it to establish whether an essentially equivalent level of protection of public health is ensured by the United Kingdom, the Commission shall inform the United Kingdom through a written notification of that finding and of the detailed reasons therefor.
2.	For a period of six months following the written notification made pursuant to the first subparagraph, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that written notification. In justified cases, the Commission may extend that period by three months.
Kadar Komisija ugotovi, da raven varstva javnega zdravja, ki jo zagotavlja Združeno kraljestvo s pravili, ki urejajo proizvodnjo, distribucijo in uporabo zdravil, ter z učinkovitim izvrševanjem navedenih pravil, v bistvu ni več enakovredna ravni varstva, zagotovljeni v Uniji, ali kadar Komisija nima na voljo zadostnih informacij, da bi ugotovila, ali Združeno kraljestvo zagotavlja v bistvu enakovredno raven varstva javnega zdravja, Združeno kraljestvo s pisnim uradnim obvestilom obvesti o tej ugotovitvi in podrobnih razlogih zanjo.	3.
V obdobju šestih mesecev po pisnem uradnem obvestilu, podanem na podagi prvega pododstavka, se Komisija posvetuje z Združenim kraljestvom za odpravo razmer, na podlagi katerih je bilo poslano to pisno uradno obvestilo. V upravičenih primerih lahko Komisija to obdobje podaljša za tri mesece.	If the situation giving rise to the written notification made pursuant to paragraph 2, first subparagraph, is not remedied within the time-limit referred to in paragraph 2, second subparagraph, the Commission shall be empowered to adopt a delegated act specifying the provisions among those referred to in paragraph 1 whose application shall be suspended.
3.	4.
Če se razmere, na podlagi katerih je bilo poslano pisno uradno obvestilo na podlagi odstavka 2, prvi pododstavek, ne odpravijo v roku iz odstavka 2, drugi pododstavek, se na Komisijo prenese pooblastilo za sprejetje delegiranega akta, v katerem se opredelijo določbe med tistimi iz odstavka 1, katerih uporaba se začasno prekine.	Where a delegated act pursuant to paragraph 3 has been adopted, the provisions referred to in the introductory sentence of paragraph 1 as specified in the delegated act shall cease to apply on the first day of the month following the entry into force of the delegated act.
4.	5.
Kadar je bil sprejet delegirani akt na podlagi odstavka 3, se določbe iz uvodnega stavka odstavka 1, kakor so navedene v delegiranem aktu, prenehajo uporabljati prvi dan v mesecu, ki sledi začetku veljavnosti delegiranega akta.	Where the situation giving rise to the adoption of the delegated act pursuant to paragraph 3 has been remedied, the Commission shall adopt a delegated act specifying those suspended provisions that shall apply again. In that case, the provisions specified in the delegated act adopted pursuant to this paragraph shall apply again on the first day of the month following the entry into force of the delegated act referred to in this paragraph.
5.	▼B
Kadar so bile razmere, zaradi katerih je bil sprejet delegirani akt na podlagi odstavka 3, odpravljene, Komisija sprejme delegirani akt, v katerem navede te določbe, katerih uporaba je začasno prekinjena, ki se ponovno uporabljajo. V temem primeru se določbe, navedene v delegiranem aktu, sprejetem na podlagi tega odstavka, ponovno uporabljajo prvi dan v mesecu po začetku veljavnosti delegiranega akta iz tega odstavka.	Article 112
▼B	Member States shall take all appropriate measures to ensure that the holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, furnish proof of the controls carried out on the medicinal product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 8(3)(h).
Člen 112	Article 113
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da imetnik dovoljenja za promet z zdravilom, in kadar je to primerno, imetnik dovoljenja za proizvodnjo, predloži dokaz o opravljenih nadzorih zdravila in/ali sestavin ter o nadzorih vmesnih faz postopka proizvodnje, v skladu s postopki, določenimi v členu 8(3)(h).	For the purpose of implementing Article 112, Member States may require manufacturers of immunological products to submit to a competent authority copies of all the control reports signed by the qualified person in accordance with Article 51.
Člen 113	Article 114
Za izvajanje člena 112 države članice lahko zahtevajo od proizvajalcev imunoloških zdravil, da pristojnemu organu predložijo izvode vseh poročil o nadzoru, ki jih podpiše odgovorna oseba v skladu s členom 51.	1.
Člen 114	Where it considers it necessary in the interests of public health, a Member State may require the holder of an authorization for marketing:
1.	—
Kadar država članica meni, da je to potrebno v interesu javnega zdravja, lahko od imetnika dovoljenja za promet z:	live vaccines,
—	—
živimi cepivi,	immunological medicinal products used in the primary immunization of infants or of other groups at risk,
—	—
imunološkimi zdravili, ki se uporabljajo v primarni imunizaciji dojenčkov ali drugih skupin s tveganjem,	immunological medicinal products used in public health immunization programmes,
—	—
imunološkimi zdravili, ki se uporabljajo v javnih zdravstvenih programih imunizacije,	new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,
—	to submit samples from each batch of the bulk and/or the medicinal product for examination ►M4 by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose ◄ before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.
novimi imunološkimi zdravili ali imunološkimi zdravili, proizvedenimi z uporabo novih ali spremenjenih vrst tehnologije ali novimi za določenega proizvajalca, med prehodnim obdobjem, ki je običajno navedeno v dovoljenju za promet z zdravilom,	2.
zahteva, da predloži vzorce vsake serije iz zbirnega vsebnika in/ali zdravila za pregled ►M4 v Uradnem kontrolnem laboratoriju za preskušanje zdravil ali laboratoriju, ki ga je za ta namen pooblastila država članica ◄ , pred dajanjem v promet, razen v primeru serije, proizvedene v drugi državi članici, ki jo je pristojni organ te države članice predhodno že pregledal ter potrdil, da ustreza odobrenim specifikacijam. Države članice zagotovijo, da se tak pregled opravi v 60-ih dneh od prejema vzorcev.	Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing ►M4 by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose ◄ before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.
2.	Article 115
Če v interesu javnega zdravja zakonodaja države članice tako predpisuje, pristojni organi od imetnika dovoljenja za promet z zdravili, pridobljenimi iz človeške krvi ali človeške plazme, lahko zahtevajo, da predloži vzorce vsake serije iz zbirnega vsebnika in/ali zdravila za preskušanje ►M4 v Uradnem kontrolnem laboratoriju za preskušanje zdravil ali laboratoriju, ki ga je za ta namen pooblastila država članica ◄ , pred sprostitvijo v prost promet, razen če niso zadevne serije pred tem že pregledali pristojni organi druge države članice in potrdili, da ustreza odobrenim specifikacijam. Države članice zagotovijo, da se tak pregled opravi v 60-ih dneh od prejema vzorcev.	Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination. To this end manufacturers shall notify the competent authorities of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma. The competent authority may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 19, or after a marketing authorization has been granted.
Člen 115	▼M10
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da se proizvodni proces in proces čiščenja pri pripravi zdravil, pridobljenih iz človeške krvi ali človeške plazme, pravilno validirata, da se dosega konsistentnost med serijami ter jamčijo, če stanje tehnologije to dopušča, da ni prišlo do specifične virusne kontaminacije. V ta namen proizvajalci uradno obvestijo pristojne organe o uporabljenem postopku za zmanjšanje ali odstranitev patogenih virusov, ki se lahko prenašajo z zdravili, pridobljenimi iz človeške krvi ali človeške plazme. Pristojni organ lahko predloži vzorce iz zbirnega vsebnika in/ali zdravila za preskus v državnem laboratoriju ali laboratoriju, pooblaščenem za ta namen, med preučevanjem vloge na podlagi člena 19 ali po izdaji dovoljenja za promet z zdravilom.	Article 116
▼M10	The competent authorities shall suspend, revoke or vary a marketing authorisation if the view is taken that the medicinal product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not favourable, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product.
Člen 116	►C2 A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 8, 10, 10a, 10b, 10c or 11 ◄ are incorrect or have not been amended in accordance with Article 23, or where any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled or where the controls referred to in Article 112 have not been carried out.
Pristojni organi začasno prekličejo, ukinejo ali spremenijo dovoljenje za promet z zdravilom, kadar se pokaže, da je zdravilo škodljivo ali ni terapevtsko učinkovito ali razmerje med tveganji in koristjo ni ugodno ali kadar njegova kakovostna in količinska sestava ne ustrezata deklarirani sestavi. Šteje se, da zdravilo terapevtsko ni učinkovito, če se ugotovi, da z njim ni mogoče doseči terapevtskih rezultatov.	▼M11
►C2 Dovoljenje za promet se lahko začasno prekliče, ukine ali spremeni, kadar so podrobni podatki v vlogi, kot je določeno v členih 8, 10, 10a, 10b, 10c ali 11, ◄ nepravilni ali niso bili spremenjeni v skladu s členom 23 ali kadar pogoji ali obveznosti iz členov 21a, 22 ali 22a niso bili izpolnjeni ali kontrole iz člena 112 niso bile opravljene.	The second paragraph of this Article also applies in cases where the manufacture of the medicinal product is not carried out in compliance with the particulars provided pursuant to point (d) of Article 8(3), or where controls are not carried out in compliance with the control methods described pursuant to point (h) of Article 8(3).
▼M11	▼B
Drugi odstavek tega člena velja tudi v primerih, ko proizvodnja zdravil ni izvedena v skladu s podatki, predloženimi v skladu s točko (d) člena 8(3), oziroma ko kontrolni preskusi niso izvedeni v skladu s kontrolnimi metodami, opisanimi v točki (h) člena 8(3).	Article 117
▼B	▼M4
Člen 117	1.
▼M4	Without prejudice to the measures provided for in Article 116, Member States shall take all appropriate steps to ensure that the supply of the medicinal product is prohibited and the medicinal product withdrawn from the market, if the view is taken that:
1.	▼M10
Ne glede na ukrepe, predpisane v členu 116, države članice sprejmejo vse ustrezne ukrepe, da zagotovijo prepoved izdajanja ali umik zdravila iz prometa, če se pokaže, da:	(a)
▼M10	the medicinal product is harmful; or
(a)	▼M4
zdravilo je škodljivo; ali	(b)
▼M4	it lacks therapeutic efficacy; or
(b)	▼M10
nima terapevtskega učinka; ali	(c)
▼M10	the risk-benefit balance is not favourable; or
(c)	▼M4
razmerje med tveganji in koristjo ni ugodno; ali	(d)
▼M4	its qualitative and quantitative composition is not as declared; or
(d)	(e)
kakovostna in količinska sestava zdravila ne ustrezata deklarirani; ali	the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled.
(e)	▼B
če niso bile opravljene kontrole zdravila in/ali sestavin ter kontrole vmesnih faz proizvodnega procesa ali če niso bile izpolnjene nekatere druge zahteve ali obveznosti v zvezi z izdanim dovoljenjem za izdelavo.	2.
▼B	The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.
2.	▼M10
Pristojni organ lahko omeji prepoved izdajanja zdravila ali umakne zdravilo iz prometa samo za sporne serije.	3.
▼M10	The competent authority may, for a medicinal product for which the supply has been prohibited or which has been withdrawn from the market in accordance with paragraphs 1 and 2, in exceptional circumstances during a transitional period allow the supply of the medicinal product to patients who are already being treated with the medicinal product.
3.	▼M11
Pristojni organ lahko za zdravilo, katerega dobave so bile prepovedane ali je umaknjen s tržišča v skladu z odstavkoma 1 in 2, v izrednih okoliščinah med prehodnim obdobjem dovoli izdajanje zdravila bolnikom, ki se s tem zdravilom že zdravijo.	Article 117a
▼M11	1.
Člen 117a	Member States shall have a system in place which aims at preventing medicinal products that are suspected to present a danger to health from reaching the patient.
1.	2.
Države članice imajo vzpostavljen sistem, da se zdravilom, ki vzbujajo sum, da so nevarna za zdravje, prepreči dostop do bolnika.	The system referred to in paragraph 1 shall cover the receipt and handling of notifications of suspected falsified medicinal products as well as of suspected quality defects of medicinal products. The system shall also cover recalls of medicinal products by marketing authorisation holders or withdrawals of medicinal products from the market ordered by national competent authorities from all relevant actors in the supply chain both during and outside normal working hours. The system shall also make it possible to recall, where necessary with the assistance of health professionals, medicinal products from patients who received such products.
2.	3.
Sistem iz odstavka 1 krije sprejemanje in obravnavanje uradnih obvestil o domnevno ponarejenih zdravilih ter o domnevnih odstopih od kakovosti zdravil. Sistem krije tudi odpoklice zdravil s strani imetnikov dovoljenja ali umike zdravil s trga, ki jih zahtevajo nacionalni pristojni organi od vseh zadevnih subjektov v dobavni verigi, v rednem delovnem času in zunaj njega. Sistem omogoča tudi odpoklic zdravil do bolnikov, ki taka zdravila prejmejo, po potrebi ob pomoči zdravstvenih delavcev.	If the medicinal product in question is suspected of presenting a serious risk to public health, the competent authority of the Member State in which that product was first identified shall, without any delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.
3.	4.
Če se za zadevno zdravilo domneva, da pomeni resno tveganje za javno zdravje, pristojni organ države članice, v kateri je bilo zdravilo najprej identificirano, nemudoma posreduje takojšnje opozorilo vsem državam članicam in subjektom v dobavni verigi v tej državi članici. Če je verjetno, da so tovrstna zdravila že prišla do bolnikov, se v roku 24 ur izda nujna javna objava, da se ta zdravila do bolnikov odpokličejo. Te objave vsebujejo dovolj informacij o domnevni napaki v kakovosti ali ponareditvi in o tveganjih, povezanih s tem.	Member States shall by 22 July 2013 notify the Commission of the details of their respective national systems referred to in this Article.
4.	▼B
Države članice do 22. julija 2013 uradno obvestijo Komisijo o podrobnostih svojih nacionalnih sistemov iz tega člena.	Article 118
▼B	1.
Člen 118	The competent authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where any one of the requirements laid down in Article 41 is no longer met.
1.	2.
Pristojni organ ukine ali začasno prekliče dovoljenje za promet za skupino pripravkov ali vse pripravke, kadar katera koli od zahtev iz člena 41 ni več izpolnjena.	In addition to the measures specified in Article 117, the competent authority may suspend manufacture or imports of medicinal products coming from third countries, or suspend or revoke the manufacturing authorization for a category of preparations or all preparations where Articles 42, 46, 51 and 112 are not complied with.
2.	▼M11
Poleg ukrepov, navedenih v členu 117, pristojni organ lahko začasno prekine proizvodnjo ali uvoz zdravil iz tretjih držav ali ukine ali začasno prekliče dovoljenje za proizvodnjo za skupino pripravkov ali za vse pripravke, kadar določbe členov 42, 46, 51 in 112 niso izpolnjene.	Article 118a
▼M11	1.
Člen 118a	The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that those penalties are implemented. The penalties must be effective, proportionate and dissuasive.
1.	Those penalties shall not be inferior to those applicable to infringements of national law of similar nature and importance.
Države članice določijo predpise o kaznih za kršenje določb nacionalne zakonodaje, sprejetih v skladu s to direktivo, in sprejmejo vse potrebne ukrepe, da zagotovijo izvrševanje teh kazni. Te kazni morajo biti učinkovite, sorazmerne in odvračilne.	2.
Te kazni niso manjše od kazni za kršitve nacionalnega prava podobne narave in teže.	The rules referred to in paragraph 1 shall address, inter alia, the following:
2.	(a)
Predpisi iz odstavka 1 med drugim urejajo:	the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as the sale of falsified medicinal products at a distance to the public by means of information society services;
(a)	(b)
proizvodnjo, distribucijo, posredovanje, uvoz in izvoz ponarejenih zdravil, ter prodajo ponarejenih zdravil na daljavo prek storitev informacijske družbe;	non-compliance with the provisions laid down in this Directive on manufacturing, distribution, import and export of active substances;
(b)	(c)
neskladnost z določbami te direktive o proizvodnji, distribuciji, uvozu in izvozu zdravilnih učinkovin;	non-compliance with the provisions laid down in this Directive on the use of excipients.
(c)	Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.
neskladnost z določbami te direktive o uporabi pomožnih snovi.	3.
Pri kaznih se po potrebi upošteva tveganje za javno zdravje s ponarejanjem zdravil.	The Member States shall notify the national provisions adopted pursuant to this Article to the Commission by 2 January 2013 and shall notify any subsequent amendment of those provisions without delay.
3.	By 2 January 2018, the Commission shall submit a report to the European Parliament and to the Council giving an overview of the transposition measures of Member States as regards this Article, together with an evaluation of the effectiveness of those measures.
Države članice obvestijo Komisijo o nacionalnih predpisih, sprejetih v skladu s tem členom, do 2. januarja 2013 in jo nemudoma obvestijo o kakršni koli poznejši spremembi teh predpisov.	Article 118b
Komisija Evropskemu parlamentu in Svetu do 2. januarja 2018 predloži poročilo o pregledu ukrepov držav članic za prenos glede tega člena, skupaj z oceno učinkovitosti teh ukrepov.	Member States shall organise meetings involving patients ‘and consumers’ organisations and, as necessary, Member States’ enforcement officers, in order to communicate public information about the actions undertaken in the area of prevention and enforcement to combat the falsification of medicinal products.
Člen 118b	Article 118c
Države članice organizirajo srečanja organizacij bolnikov in potrošnikov, po potrebi tudi organov pregona držav članic, da se javnost obvesti o izvedenih preventivnih in izvršilnih ukrepih v boju proti ponarejanju zdravil.	Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.
Člen 118c	▼M4
Države članice pri uporabi te direktive storijo vse, kar je potrebno, da se zagotovi sodelovanje med pristojnimi organi za zdravila in carinskimi organi.	Article 119
▼M4	The provisions of this Title shall apply to homeopathic medicinal products.
Člen 119	▼B
Določbe tega naslova se uporabljajo za homeopatska zdravila.	TITLE XII
▼B	STANDING COMMITTEE
NASLOV XII	▼M15
STALNI ODBOR	Article 120
▼M15	The Commission is empowered to adopt delegated acts in accordance with Article 121a amending Annex I to take account of scientific and technical progress.
Člen 120	▼M4
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za spremembo Priloge I, da se upoštevata znanstveni in tehnični napredek.	Article 121
▼M4	1.
Člen 121	The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called ‘the Standing Committee’, in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector.
1.	2.
Komisiji pomaga Stalni odbor za zdravila za uporabo v humani medicini, v nadaljnjem besedilu „Stalni odbor“, glede prilagajanja tehničnemu napredku direktiv za odstranjevanje tehničnih ovir v trgovanju na področju zdravil.	Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
2.	The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Pri sklicevanju na ta odstavek se ob upoštevanju določb člena 8 Sklepa 1999/468/ES uporabljata člena 5 in 7 navedenega sklepa.	▼M15 —————
Obdobje iz člena 5(6) Sklepa 1999/468/ES so trije meseci.	▼M4
▼M15 —————	3.
▼M4	Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3.	The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
Pri sklicevanju na ta odstavek se ob upoštevanju določb člena 8 Sklepa 1999/468/ES uporabljata člena 4 in 7 navedenega sklepa. Obdobje iz člena 4(3) Sklepa 1999/468/ES je en mesec.	▼M7
▼M7	4.
4.	The rules of procedure of the Standing Committee shall be made public.
Poslovnik stalnega odbora se objavi.	▼M15
▼M15	Article 121a
Člen 121a	1.
1.	The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.	2.
2.	The power to adopt delegated acts referred to in Article 14(1), Article 22b, Article 23b, Article 46a, Article 47, Article 52b, Article 54a and Article 120 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Pooblastilo za sprejemanje delegiranih aktov iz člena 14(1), člena 22b, člena 23b, člena 46a, člena 47, člena 52b, člena 54a in člena 120 se prenese na Komisijo za obdobje petih let od 26. julija 2019. Komisija pripravi poročilo o prenosu pooblastila najpozneje devet mesecev pred koncem petletnega obdobja. Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.	▼M16
▼M16	The power to adopt delegated acts referred to in Article 111c(3) and (5) shall be conferred on the Commission for an indeterminate period of time from 20 April 2022.
Pooblastilo za sprejemanje delegiranih aktov iz člena 111c(3) in (5) se prenese na Komisijo za nedoločen čas od 20. aprila 2022.	▼M16
▼M16	3.
3.	The delegation of power referred to in Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) and (5), and Article 120 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Prenos pooblastila iz člena 14(1), členov 22b, 23b, 46a, 47, 52b, 54a, člena 111c(3) in (5) ter člena 120 lahko kadar koli prekliče Evropski parlament ali Svet. S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa. Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu. Sklep ne vpliva na veljavnost že veljavnih delegiranih aktov.	▼M15
▼M15	4.
4.	Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ( 15 ).
Komisija se pred sprejetjem delegiranega akta posvetuje s strokovnjaki, ki jih imenujejo države članice, v skladu z načeli, določenimi v Medinstitucionalnem sporazumu z dne 13. aprila 2016 o boljši pripravi zakonodaje ( 15 ).	5.
5.	As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Komisija takoj po sprejetju delegiranega akta o njem sočasno uradno obvesti Evropski parlament in Svet.	▼M16
▼M16	6.
6.	A delegated act adopted pursuant to Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) or (5), or Article 120 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Delegirani akt, sprejet na podlagi člena 14(1), členov 22b, 23b, 46a, 47, 52b, 54a, člena 111c(3) ali (5) ali člena 120, začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala. Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za dva meseca.	▼B
▼B	TITLE XIII
NASLOV XIII	GENERAL PROVISIONS
SPLOŠNE DOLOČBE	▼M4
▼M4	Article 122
Člen 122	1.
1.	Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements placed on the authorisations referred to in Articles 40 and 77, on the certificates referred to in Article 111(5) or on the marketing authorisations are fulfilled.
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo medsebojno obveščanje med zadevnimi pristojnimi organi o informacijah, kot je ustrezno, da se zagotavlja izpolnjevanje zahtev za izdajo dovoljenj iz člena 40 in 77, za izdajo certifikatov iz člena 111(5), ali za izdajo dovoljenj za promet z zdravili.	▼M10
▼M10	2.
2.	Upon reasoned request, Member States shall send electronically the reports referred to in Article 111(3) to the competent authorities of another Member State or to the Agency.
Na utemeljeno zahtevo države članice pristojnim organom druge države članice ali Agenciji elektronsko pošljejo poročila iz člena 111(3).	▼M4
▼M4	3.
3.	The conclusions reached in accordance with Article 111(1) shall be valid throughout the Community.
Odločitve, sprejete v skladu s členom 111(1), veljajo v vsej Skupnosti.	However, in exceptional cases, if a Member State is unable, for reasons relating to public health, to accept the conclusions reached following an inspection under Article 111(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned.
V izjemnih primerih, če država članica zaradi razlogov javnega zdravja ne more sprejeti odločitev, sprejetih na podlagi inšpekcijskega pregleda po členu 111(1), država članica o tem nemudoma obvesti Komisijo in Agencijo. Agencija obvesti zadevne države članice.	When the Commission is informed of these divergences of opinion, it may, after consulting the Member States concerned, ask the inspector who performed the original inspection to perform a new inspection; the inspector may be accompanied by two other inspectors from Member States which are not parties to the disagreement.
Kadar je Komisija obveščena o teh razhajanjih mnenj, lahko po posvetovanju z zadevnimi državami članicami, inšpektorja, ki je opravil prvotni pregled, prosi, da opravi ponovni pregled; inšpektorja lahko spremljata še dva inšpektorja iz držav članic, ki niso stranke v tem sporu.	▼B
▼B	Article 123
Člen 123	1.
1.	Each Member State shall take all the appropriate measures to ensure that decisions authorizing marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Agency forthwith.
Vsaka država članica sprejme ustrezne ukrepe, da zagotovi takojšnje obveščanje Agencije o odločitvah glede odobritve dovoljenja za promet, zavrnitve ali preklica dovoljenja za promet z zdravilom, o razveljavitvi odločitve glede zavrnitve ali preklica dovoljenja za promet z zdravilom, o prepovedi izdajanja ali umiku zdravila iz prometa, skupaj z razlogi za take odločitve.	▼M12
▼M12	2.
2.	The marketing authorisation holder shall be obliged to notify the Member States concerned forthwith of any action taken by the holder to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in Article 116 or Article 117(1).
Imetnik dovoljenja za promet je dolžan zadevne države članice takoj obvestiti o vseh ukrepih, ki jih je sprejel za začasen umik zdravila iz prometa, umik zdravila iz prometa, za zahtevo za umik dovoljenja za promet ali za nepodaljšanje dovoljenja za promet, skupaj z razlogi za tako ukrepanje. Imetnik dovoljenja za promet zlasti navede, ali tako ukrepanje temelji na katerem koli od razlogov iz člena 116 ali člena 117(1).	2a.
2a.	The marketing authorisation holder shall also make the notification pursuant to paragraph 2 of this Article in cases where the action is taken in a third country and where such action is based on any of the grounds set out in Article 116 or Article 117(1).
Imetnik dovoljenja za promet pošlje obvestilo v skladu z odstavkom 2 tega člena tudi, kadar ukrepa v tretji državi in kadar ukrep temelji na razlogih iz člena 116 ali člena 117(1).	2b.
2b.	The marketing authorisation holder shall furthermore notify the Agency where the action referred to in paragraph 2 or 2a of this Article is based on any of the grounds referred to in Article 116 or Article 117(1).
Imetnik dovoljenja za promet poleg tega obvesti Agencijo, kadar ukrep iz odstavka 2 ali 2a tega člena temelji na katerem koli od razlogov iz člena 116 ali člena 117(1).	2c.
2c.	The Agency shall forward notifications received in accordance with paragraph 2b to all Member States without undue delay.
Agencija v skladu z odstavkom 2b informacije nemudoma posreduje vsem državam članicam.	▼B
▼B	3.
3.	Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization, with a copy to the Agency.
Države članice zagotovijo, da se Svetovno zdravstveno organizacijo, ter s kopijo tudi Agencijo, takoj ustrezno obvesti o ukrepih, sprejetih v skladu z odstavkoma 1 in 2, ki lahko vplivajo na varovanje javnega zdravja v tretjih državah.	▼M12
▼M12	4.
4.	Each year, the Agency shall make public a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended in the Union, whose supply has been prohibited or which have been withdrawn from the market, including the reasons for such action.
Agencija vsako leto objavi seznam zdravil, za katera je bilo dovoljenje za promet v Uniji zavrnjeno, ukinjeno ali začasno odvzeto, katerih dobava je bila prepovedana ali ki so bila umaknjena s trga, skupaj z razlogi za tako ukrepanje.	▼B
▼B	Article 124
Člen 124	Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 122 and 123.
Države članice se medsebojno obveščajo o vseh potrebnih informacijah za zagotavljanje kakovosti in varnosti homeopatskih zdravil, ki se proizvajajo in dajejo v promet v Skupnosti, zlasti o informacijah iz členov 122 in 123.	Article 125
Člen 125	Every decision referred to in this Directive which is taken by the competent authority of a Member State shall state in detail the reasons on which it is based.
Pristojni organ države članice navede podrobne razloge za vsako odločitev, sprejeto na podlagi te direktive.	Such decision shall be notified to the party concerned, together with information as to the redress available to him under the laws in force and of the time-limit allowed for access to such redress.
O odločitvi obvesti zainteresirano stranko skupaj z informacijo o možnosti poprave, ki je stranki na voljo po veljavni zakonodaji in o časovnem roku, v katerem je omogočeno koriščenje dane možnosti.	▼M4
▼M4	Decisions to grant or revoke a marketing authorisation shall be made publicly available.
Sklepi o izdaji ali umiku dovoljenja za promet z zdravilom se javno objavijo.	▼B
▼B	Article 126
Člen 126	An authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive.
Dovoljenje za promet z zdravilom se sme zavrniti, umakniti ali preklicati samo na podlagi določb iz te direktive.	No decision concerning suspension of manufacture or of importation of medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a medicinal product may be taken except on the grounds set out in Articles 117 and 118.
Sklep o začasni prekinitvi proizvodnje ali uvoza zdravil iz tretjih držav, o prepovedi izdajanja ali umiku zdravila iz prometa se sme sprejeti samo na podlagi določb iz členov 117 in 118.	▼M4
▼M4	Article 126a
Člen 126a	1.
1.	In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product.
Kadar zdravilo nima dovoljenja za promet ali v primeru nerešene vloge za pridobitev dovoljenja za promet za zdravilo, za katero je bilo v skladu s to direktivo dovoljenje izdano v drugi državi članici, država članica lahko iz utemeljenih razlogov javnega zdravja odobri dajanje omenjenega zdravila na trg.	▼M10
▼M10	2.
2.	When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Titles V, VI, VIII, IX and XI. Member States may decide that Article 63(1) and (2) shall not apply to medicinal products authorised under paragraph 1.
Kadar država članica izkoristi to možnost, sprejme potrebne ukrepe za zagotovitev, da so izpolnjene zahteve iz te direktive, zlasti tiste iz naslovov V, VI, VIII, IX in XI. Države članice lahko sklenejo, da se člen 63(1) in (2) ne uporablja za zdravila, odobrena v skladu z odstavkom 1.	3.
3.	Before granting such a marketing authorisation, a Member State:
Pred izdajo takšnega dovoljenja za promet z zdravilom država članica:	(a)
(a)	shall notify the marketing authorisation holder, in the Member State in which the medicinal product concerned is authorised, of the proposal to grant a marketing authorisation under this Article in respect of the medicinal product concerned.
uradno obvesti imetnika dovoljenja za promet z zdravilom v državi članici, v kateri je zadevno zdravilo odobreno, o predlogu za izdajo dovoljenja za promet z zdravilom na podlagi tega člena, kar zadeva zadevno zdravilo;	(b)
(b)	may request the competent authority in that Member State to submit copies of the assessment report referred to in Article 21(4) and of the marketing authorisation in force in respect of the medicinal product concerned. If so requested, the competent authority in that Member State shall supply, within 30 days of receipt of the request, a copy of the assessment report and the marketing authorisation in respect of the medicinal product concerned.
od pristojnega organa v tej državi lahko zahteva, da predloži izvod poročila o oceni zdravila iz člena 21(4) ter izvod veljavnega dovoljenja za promet z zadevnim zdravilom. V primeru takšne zahteve pristojni organ v tej državi v 30 dneh od prejema zahteve predloži izvod poročila o oceni zdravila in dovoljenje za promet z zadevnim zdravilom.	▼M4
▼M4	4.
4.	The Commission shall set up a publicly accessible register of medicinal products authorised under paragraph 1. Member States shall notify the Commission if any medicinal product is authorised, or ceases to be authorised, under paragraph 1, including the name or corporate name and permanent address of the authorisation holder. The Commission shall amend the register of medicinal products accordingly and make this register available on their website.
Komisija vzpostavi javno dostopen register zdravil, ki imajo dovoljenje za promet, izdano na podlagi odstavka 1. Države članice obvestijo Komisijo, kadar zdravilo ima dovoljenje za promet ali kadar dovoljenja za promet nima, na podlagi odstavka 1, vključno z imenom ali nazivom podjetja in stalnim naslovom imetnika dovoljenja. Komisija ustrezno dopolni register zdravil in ga objavi na svoji spletni strani.	5.
5.	No later than 30 April 2008, the Commission shall present a report to the European Parliament and the Council concerning the application of this provision with a view to proposing any necessary amendments.
Najpozneje do 30. aprila 2008 Komisija predstavi poročilo Evropskemu parlamentu in Svetu glede uporabe te določbe zaradi predlaganja katere koli potrebne spremembe.	Article 126b
Člen 126b	In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry which could affect their impartiality. These persons shall make an annual declaration of their financial interests.
Za zagotavljanje neodvisnosti in preglednosti, države članice zagotovijo, da člani osebja pristojnega organa, odgovornega za izdajanje dovoljenj, poročevalci in strokovnjaki, ki so vključeni v izdajo dovoljenj in nadzor zdravil, nimajo finančnih ali drugih interesov v farmacevtski industriji, ki bi lahko vplivali na njihovo nepristranskost. Te osebe pripravijo letno izjavo o svojih finančnih interesih. Poleg tega države članice zagotovijo, da pristojni organ javno objavi svoj poslovnik in poslovnik svojih odborov, dnevne rede za svoje sestanke in zapisnike sestankov, skupaj s sprejetimi sklepi, podrobnostmi glasovanja in razlage glasovanja, vključno z manjšinskimi mnenji.	In addition, the Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.
▼M16	▼M16
Člen 126c	Article 126c
1.	1.
Z odstopanjem od člena 126a lahko pristojni organi Cipra in Malte do 31. decembra 2024 v odsotnosti dovoljenja za promet ali nerešene vloge za dovoljenje za promet iz utemeljenih javnozdravstvenih razlogov odobrijo dajanje zdravila, odobrenega v delih Združenega kraljestva razen Severne Irske, v promet na svojem nacionalnem trgu.	By way of derogation from Article 126a, until 31 December 2024, in the absence of a marketing authorisation or of a pending application for a marketing authorisation the competent authorities of Cyprus and Malta may authorise for justified public health reasons the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.
Pristojni organi Cipra in Malte lahko prav tako ohranijo v veljavi ali do 31. decembra 2024 podaljšajo dovoljenja za promet, ki so bila izdana na podlagi člena 126a pred 20. aprilom 2022, ki na njihovem nacionalnem trgu dovoljujejo dajanje v promet zdravila, odobrenega v delih Združenega kraljestva razen Severne Irske.	The competent authorities of Cyprus and Malta may also maintain in force or, until 31 December 2024, extend marketing authorisations that were granted pursuant to Article 126a before 20 April 2022 which authorise the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.
Dovoljenja, ki so izdana, podaljšana ali ohranjena v veljavi na podlagi prvega ali drugega pododstavka, ne veljajo po 31. decembru 2026.	Authorisations that are granted, extended or maintained in force pursuant to the first or second subparagraph shall not be valid after 31 December 2026.
2.	2.
Z odstopanjem od člena 8(2) lahko pristojni organi Malte in Cipra izdajo dovoljenja za promet iz odstavka 1 tega člena imetnikom dovoljenj za promet s sedežem v delih Združenega kraljestva razen Severne Irske.	By way of derogation from Article 8(2), the competent authorities of Malta and Cyprus may grant marketing authorisations as referred to in paragraph 1 of this Article to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.
3.	3.
Kadar pristojni organi Cipra ali Malte izdajo ali podaljšajo dovoljenje za promet iz odstavka 1, zagotovijo skladnost z zahtevami iz te direktive.	Where the competent authorities of Cyprus or Malta grant or extend a marketing authorisation as referred to in paragraph 1, they shall ensure compliance with the requirements of this Directive.
4.	4.
Pred izdajo dovoljenja za promet na podlagi odstavka 1 pristojni organi Cipra ali Malte:	Before granting a marketing authorisation pursuant to paragraph 1, the competent authorities of Cyprus or Malta:
(a)	(a)
imetnika dovoljenja za promet, ki se nahaja v delih Združenega kraljestva razen Severne Irske, obvestijo o predlogu glede izdaje dovoljenja za promet ali podaljšanja veljavnosti dovoljenja za promet na podlagi tega člena v zvezi z zadevnim zdravilom;	shall notify the marketing authorisation holder in parts of the United Kingdom other than Northern Ireland of the proposal to grant a marketing authorisation or to extend a marketing authorisation under this Article in respect of the medicinal product concerned;
(b)	(b)
lahko od pristojnega organa Združenega kraljestva zahtevajo predložitev ustreznih informacij o dovoljenju za promet z zadevnim zdravilom.	may request the competent authority in the United Kingdom to submit the relevant information regarding the marketing authorisation of the medicinal product concerned.
▼B	▼B
Člen 127	Article 127
1.	1.
Na zahtevo proizvajalca, izvoznika ali organov tretje države uvoznice, države članice potrdijo, da ima proizvajalec zdravil dovoljenja za proizvodnjo zdravil. Pri izdajanju teh potrdil države članice upoštevajo naslednje pogoje:	At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization. When issuing such certificates Member States shall comply with the following conditions:
(a)	(a)
obstoječe upravne dogovore Svetovne zdravstvene organizacije;	they shall have regard to the prevailing administrative arrangements of the World Health Organization;
(b)	(b)
za zdravila, namenjena za izvoz, za katera že imajo dovoljenje za promet na svojem ozemlju, predložijo povzetek glavnih značilnosti zdravila, kot je odobren v skladu s členom 21.	for medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 21.
2.	2.
Če proizvajalec nima dovoljenja za promet z zdravilom, organom za izdajo potrdil iz odstavka 1 predloži izjavo z obrazložitvijo razloga, zakaj dovoljenje za promet z zdravilom ni na voljo.	When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to in paragraph 1, with a declaration explaining why no marketing authorization is available.
▼M10	▼M10
Člen 127a	Article 127a
Kadar se zdravilo odobri v skladu z Uredbo (ES) št. 726/2004 in Odbor za zdravila za uporabo v humani medicini v svojem mnenju opozori na priporočene pogoje ali omejitve, kot je določeno v točkah (c), (ca), (cb) ali (cc) člena 9(4) Uredbe, Komisija lahko sprejme odločbo, naslovljeno na države članice, v skladu s postopkom iz členov 33 in 34 te direktive, za izvajanje navedenih pogojev ali omejitev.	When a medicinal product is to be authorised in accordance with Regulation (EC) No 726/2004, and the Committee for Medicinal Products for Human Use in its opinion refers to recommended conditions or restrictions as provided for in points (c), (ca), (cb) or (cc) of Article 9(4) thereof, the Commission may adopt a decision addressed to the Member States, in accordance with Articles 33 and 34 of this Directive, for the implementation of those conditions or restrictions.
▼M4	▼M4
Člen 127b	Article 127b
Države članice zagotovijo, da za zdravila, ki niso bila uporabljena ali jim je pretekel rok uporabnosti, veljajo ustrezni sistemi zbiranja.	Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.
▼M16	▼M16
Člen 127c	Article 127c
Odstopanja iz člena 8(2a) in (2b), člena 18a, člena 20, drugi odstavek, člena 40(1a) in (3a), člena 48(3), člena 104(3a) in člena 126c ne vplivajo na obveznosti imetnika dovoljenja za promet, da zagotovi kakovost, varnost in učinkovitost zdravila, danega v promet na trgu Cipra, Irske, Malte ali Severne Irske, iz te direktive.	The derogations set out in Article 8(2a) and(2b), Article 18a, Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3a) and Article 126c shall not affect the obligations of the marketing authorisation holder to ensure the quality, safety and efficacy of the medicinal product placed on the markets of Cyprus, Ireland, Malta or Northern Ireland laid down in this Directive.
Člen 127d	Article 127d
1.	1.
Do 20. maja 2022 pristojni organi Cipra, Irske, Malte in Združenega kraljestva v zvezi s Severno Irsko pripravijo seznam zdravil, za katera so uporabili ali nameravajo uporabiti odstopanja iz te direktive, o njem uradno obvestijo Komisijo in ga objavijo na svojem spletišču.	By 20 May 2022, the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland shall establish, notify to the Commission and publish on their website a list of medicinal products to which they have applied or intend to apply the derogations as set out in this Directive.
2.	2.
Pristojni organi Cipra, Irske, Malte in Združenega kraljestva v zvezi s Severno Irsko zagotovijo, da se seznam iz odstavka 1 na neodvisen način posodablja in upravlja vsaj vsakih šest mesecev.	The competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland shall ensure that the list referred to in paragraph 1 is updated and managed in an independent manner, at least on a six-monthly basis.
▼B	▼B
NASLOV XIV	TITLE XIV
KONČNE DOLOČBE	FINAL PROVISIONS
Člen 128	Article 128
Direktive 65/65/EGS, 75/318/EGS, 75/319/EGS, 89/342/EGS, 89/343/EGS, 89/381/EGS, 92/25/EGS, 92/26/EGS, 92/27/EGS, 92/28/EGS in 92/73/EGS, spremenjene z direktivami iz dela A Priloge II, se razveljavijo, ne da bi posegale v obveznosti držav članic, kar zadeva časovne roke za izvajanje, določene v delu B Priloge II.	Directives 65/65/EEC, 75/318/EEC, 75/319/EEC, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/25/EEC, 92/26/EEC, 92/27/EEC, 92/28/EEC and 92/73/EEC, amended by the Directives referred to in Annex II, Part A, are repealed, without prejudice to the obligations of the Member States concerning the time-limits for implementation set out in Annex II, Part B.
Sklici na razveljavljene direktive pomenijo sklice na to direktivo in se berejo v skladu s korelacijsko preglednico v Prilogi III.	References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Člen 129	Article 129
Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropskih skupnosti.	This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Člen 130	Article 130
Ta direktiva je naslovljena na države članice.	This Directive is addressed to the Member States.
▼M2	▼M2
PRILOGA I	ANNEX I
ANALIZNI, FARMAKOLOŠKO-TOKSIKOLOŠKI IN KLINIČNI STANDARDI TER PROTOKOLI ZA PRESKUŠANJE ZDRAVIL	ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
VSEBINA	TABLE OF CONTENTS
Uvod in splošna načela	Introduction and general principles
Del I: \| Standardizirane zahteve za dokumentacijo za pridobitev dovoljenja za promet z zdravilom	Part I: Standardised marketing authorisation dossier requirements
1. \| Modul 1: Administrativni podatki	1.
1.1 \| Pregled vsebine	1.1.
1.2 \| Obrazec vloge	1.2.
1.3 \| Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo	1.3.
1.3.1 \| Povzetek glavnih značilnosti zdravila	1.3.1.
1.3.2 \| Označevanje in navodilo za uporabo	1.3.2.
1.3.3 \| Osnutki in vzorci	1.3.3.
1.3.4 \| Povzetek glavnih značilnosti zdravila, ki je že dobilo dovoljenje v državah članicah	1.3.4.
1.4 \| Podatki o strokovnjakih	1.4.
1.5 \| Posebne zahteve za različne vrste vlog	1.5.
1.6 \| Ocena tveganja za okolje	1.6.
2. \| Modul 2: Povzetki	2.
2.1 \| Celoten pregled vsebine	2.1.
2.2 \| Uvod	2.2.
2.3 \| Celoten povzetek o kakovosti zdravila	2.3.
2.4 \| Pregled neklinične dokumentacije	2.4.
2.5 \| Pregled klinične dokumentacije	2.5.
2.6 \| Povzetek neklinične dokumentacije	2.6.
2.7 \| Povzetek klinične dokumentacije	2.7.
3. \| Modul 3: Kemijski, farmacevtski in biološki podatki za zdravila, ki vsebujejo kemične in/ali biološke zdravilne učinkovine	3.
3.1 \| Struktura in oblika	3.1.
3.2 \| Vsebina: osnovna načela in zahteve	3.2.
3.2.1 \| Zdravilna/e učinkovina/e	3.2.1.
3.2.1.1 \| Splošni podatki in podatki o vhodnih snoveh in surovinah	3.2.1.1.
3.2.1.2 \| Postopek proizvodnje zdravilne(-ih) učinkovine/učinkovin	3.2.1.2.
3.2.1.3 \| Opis lastnosti zdravilne(-ih) učinkovine/učinkovin	3.2.1.3.
3.2.1.4 \| Kontrola zdravilne(-ih) učinkovine/učinkovin	3.2.1.4.
3.2.1.5 \| Referenčni standardi ali snovi	3.2.1.5.
3.2.1.6 \| Vsebnik in sistem zapiranja zdravilne učinkovine	3.2.1.6.
3.2.1.7 \| Stabilnost zdravilne(-ih) učinkovine/učinkovin	3.2.1.7.
3.2.2 \| Končni izdelek	3.2.2.
3.2.2.1 \| Opis in sestava končnega izdelka	3.2.2.1.
3.2.2.2 \| Farmacevtski razvoj	3.2.2.2.
3.2.2.3 \| Postopek proizvodnje končnega izdelka	3.2.2.3.
3.2.2.4 \| Kontrola pomožnih snovi	3.2.2.4.
3.2.2.5 \| Kontrola končnega izdelka	3.2.2.5.
3.2.2.6 \| Referenčni standardi ali snovi	3.2.2.6.
3.2.2.7 \| Vsebnik in zapiranje končnega izdelka	3.2.2.7.
3.2.2.8 \| Stabilnost končnega izdelka	3.2.2.8.
4. \| Modul 4: Neklinična poročila	4.
4.1 \| Struktura in oblika	4.1.
4.2 \| Vsebina: osnovna načela in zahteve	4.2.
4.2.1 \| Farmakologija	4.2.1.
4.2.2 \| Farmakokinetika	4.2.2.
4.2.3 \| Toksikologija	4.2.3.
5. \| Modul 5: Poročila o kliničnih študijah	5.
5.1 \| Struktura in oblika	5.1.
5.2 \| Vsebina: Osnovna načela in zahteve	5.2.
5.2.1 \| Poročila o biofarmacevtskih študijah	5.2.1.
5.2.2 \| Poročila o študijah, ki se nanašajo na farmakokinetiko ob uporabi človeških bioloških materialov	5.2.2.
5.2.3 \| Poročila o farmakokinetičnih študijah pri ljudeh	5.2.3.
5.2.4 \| Poročila o farmakodinamičnih študijah pri ljudeh	5.2.4.
5.2.5 \| Poročila o študijah učinkovitosti in varnosti	5.2.5.
5.2.5.1 \| Poročila o kontroliranih kliničnih študijah, ki se nanašajo na določeno indikacijo	5.2.5.1.
5.2.5.2 \| Poročila o nekontroliranih kliničnih študijah analiz podatkov iz več kot ene študije in druga poročila o kliničnih študijah	5.2.5.2.
5.2.6 \| Poročila o izkušnjah z zdravilom po začetku trženja	5.2.6.
5.2.7 \| Obrazci za poročanje o posameznih primerih in seznami posameznih primerov bolnikov	5.2.7.
Del II: \| Posebne dokumentacije za pridobitev dovoljenja za promet z zdravilom in zahteve	Part II: Specific marketing authorisation dossiers and requirements
1. \| Dobro uveljavljena medicinska uporaba	1.
2. \| Bistveno podobna zdravila	2.
3. \| Dodatni podatki, ki se zahtevajo v posebnih primerih	3.
4. \| Podobna biološka zdravila	4.
5. \| Zdravila z določeno kombinacijo	5.
6. \| Dokumentacija za vloge v izjemnih okoliščinah	6.
7. \| Mešane vloge za pridobitev dovoljenja za promet z zdravilom	7.
Del III: \| Posebna zdravila	Part III: Particular medicinal products
1. \| Biološka zdravila	1.
1.1 \| Zdravila, pridobljena iz človeške plazme	1.1.
1.2 \| Cepiva	1.2.
2. \| Radiofarmacevtski izdelki in predhodne sestavine	2.
2.1 \| Radiofarmacevtski izdelki	2.1.
2.2 \| Radiofarmacevtski predhodne sestavine za namene radiološkega označevanja	2.2.
3. \| Homeopatska zdravila	3.
4. \| Zdravila rastlinskega izvora	4.
5. \| Zdravila sirote	5.
Del IV: \| Zdravila za napredno zdravljenje	Part IV: \| Advanced therapy medicinal products
1. \| Uvod	1. \| Introduction
2. \| Opredelitve	2. \| Definitions
2.1 \| Zdravilo za gensko zdravljenje	2.1. \| Gene therapy medicinal product
2.2 \| Zdravilo za somatsko celično zdravljenje	2.2. \| Somatic cell therapy medicinal product
3. \| Posebne zahteve v zvezi z modulom 3	3. \| Specific requirements regarding Module 3
3.1 \| Posebne zahteve za vsa zdravila za napredno zdravljenje	3.1. \| Specific requirements for all advanced therapy medicinal products
3.2 \| Posebne zahteve za zdravila za gensko zdravljenje	3.2. \| Specific requirements for gene therapy medicinal products
3.2.1 \| Uvod: končni izdelek, zdravilna učinkovina in vhodne snovi	3.2.1. \| Introduction: finished product, active substance and starting materials
3.2.1.1 \| Zdravilo za gensko zdravljenje, ki vsebuje rekombinantna zaporedja nukleinskih kislin ali gensko spremenjene mikroorganizme ali viruse	3.2.1.1. \| Gene therapy medicinal product containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)
3.2.1.2 \| Zdravilo za gensko zdravljenje, ki vsebuje gensko spremenjene celice	3.2.1.2. \| Gene therapy medicinal product containing genetically modified cells
3.2.1.3	3.2.1.3.
3.2.1.4	3.2.1.4.
3.2.1.5	3.2.1.5.
3.2.2 \| Posebne zahteve	3.2.2. \| Specific requirements
3.3 \| Posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva	3.3. \| Specific requirements for somatic cell therapy medicinal products and tissue engineered products
3.3.1 \| Uvod: končni izdelek, zdravilna učinkovina in vhodne snovi	3.3.1. \| Introduction: finished product, active substance and starting materials
3.3.2 \| Posebne zahteve	3.3.2. \| Specific requirements
3.3.2.1 \| Vhodne snovi	3.3.2.1. \| Starting materials
3.3.2.2 \| Postopek izdelave	3.3.2.2. \| Manufacturing process
3.3.2.3 \| Opis lastnosti in strategija nadzora	3.3.2.3. \| Characterisation and control strategy
3.3.2.4 \| Pomožne snovi	3.3.2.4. \| Excipients
3.3.2.5 \| Razvojne študije	3.3.2.5. \| Developmental studies
3.3.2.6 \| Referenčni materiali	3.3.2.6. \| Reference materials
3.4 \| Posebne zahteve za zdravila za napredno zdravljenje, ki vključujejo pripomočke	3.4. \| Specific requirements for advanced therapy medicinal products containing devices
3.4.1 \| Zdravila za napredno zdravljenje, ki vključujejo pripomočke, kot so opredeljeni v členu 7 Uredbe (ES) št. 1394/2007	3.4.1. \| Advanced therapy medicinal product containing devices as referred to in Article 7 of Regulation (EC) No 1394/2007
3.4.2 \| Kombinirana zdravila za napredno zdravljenje, kot so opredeljena v členu 2(1)(d) Uredbe (ES) št. 1394/2007	3.4.2. \| Combined advanced therapy medicinal products as defined in Article 2(1)(d) of Regulation (EC) No 1394/2007
4. \| Posebne zahteve v zvezi z modulom 4	4. \| Specific requirements regarding module 4
4.1 \| Posebne zahteve za vsa zdravila za napredno zdravljenje	4.1. \| Specific requirements for all advanced therapy medicinal products
4.2 \| Posebne zahteve za zdravila za gensko zdravljenje	4.2. \| Specific requirements for gene therapy medicinal products
4.2.1 \| Farmakologija	4.2.1. \| Pharmacology
4.2.2 \| Farmakokinetika	4.2.2. \| Pharmacokinetics
4.2.3 \| Toksikologija	4.2.3. \| Toxicology
4.3 \| Posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva	4.3. \| Specific requirements for somatic cell therapy medicinal products and tissue engineered products
4.3.1 \| Farmakologija	4.3.1. \| Pharmacology
4.3.2 \| Farmakokinetika	4.3.2. \| Pharmacokinetics
4.3.3 \| Toksikologija	4.3.3. \| Toxicology
5. \| Posebne zahteve v zvezi z modulom 5	5. \| Specific requirements regarding module 5
5.1 \| Posebne zahteve za vsa zdravila za napredno zdravljenje	5.1. \| Specific requirements for all advanced therapy medicinal products
5.2 \| Posebne zahteve za zdravila za gensko zdravljenje	5.2. \| Specific requirements for gene therapy medicinal products
5.2.1 \| Študije o farmakokinetiki pri ljudeh	5.2.1. \| Human pharmacokinetic studies
5.2.2 \| Študije o farmakodinamiki pri ljudeh	5.2.2. \| Human pharmacodynamic studies
5.2.3 \| Študije o varnosti	5.2.3. \| Safety studies
5.3 \| Posebne zahteve za zdravila za somatsko celično zdravljenje	5.3. \| Specific requirements for somatic cell therapy medicinal products
5.3.1 \| Zdravila za somatsko celično zdravljenje, pri katerih temelji način delovanja na proizvodnji določenih aktivnih biomolekul	5.3.1. \| Somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s)
5.3.2 \| Biološka porazdelitev, obstojnost in dolgoročna vsaditev sestavin zdravil za somatsko celično zdravljenje	5.3.2. \| Biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components
5.3.3 \| Študije o varnosti	5.3.3. \| Safety studies
5.4 \| Posebne zahteve za izdelke tkivnega inženirstva	5.4. \| Specific requirements for tissue engineered products
5.4.1 \| Študije o farmakokinetiki	5.4.1. \| Pharmacokinetic studies
5.4.2 \| Študije o farmakodinamiki	5.4.2. \| Pharmacodynamic studies
5.4.3 \| Študije o varnosti	5.4.3. \| Safety studies
Uvod in splošna načela	Introduction and general principles
(1) \| Podrobni podatki in dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi členov 8 in 10(1), se predložijo v skladu z zahtevami iz te priloge ter ob upoštevanju navodil, ki jih je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski skupnosti, zvezek 2 B, Obvestilo vlagateljem, Zdravila za ljudi, Oblika in vsebina dokumentacije, Skupni tehnični dokument (CTD).	(1) \| The particulars and documents accompanying an application for marketing authorisation pursuant to Articles 8 and 10 (1) shall be presented in accordance with the requirements set out in this Annex and shall follow the guidance published by the Commission in The rules governing medicinal products in the European Community, Volume 2 B, Notice to applicants, Medicinal products for human use, Presentation and content of the dossier, Common Technical Document (CTD).
(2) \| Podrobni podatki in dokumenti se predložijo v petih modulih: Modul 1 Evropski skupnosti zagotavlja podrobno opredeljene administrativne podatke; Module 2 zagotavlja povzetke o kakovosti, neklinične in klinične povzetke, Modul 3 zagotavlja kemične, farmacevtske in biološke podatke, Modul 4 zagotavlja neklinična poročila in Modul 5 poročila o kliničnih študijah. Ta oblika uveljavlja splošno strukturo za vse regije ICH ( 16 ) (Evropska skupnost, Združene države Amerike, Japonska). Navedenih pet modulov se predloži v strogi skladnosti s strukturo, vsebino in sistemom številčenja, podrobno opisanimi v zvezku 2 B Obvestilo vlagateljem, ki so navedeni zgoraj.	(2) \| The particulars and documents shall be presented as five modules: Module 1 provides European Community specific administrative data; Module 2 provides quality, non-clinical and clinical summaries, Module 3 provides chemical, pharmaceutical and biological information, Module 4 provides non-clinical reports and Module 5 provides clinical study reports. This presentation implements a common format for all ICH ( 16 ) regions (European Community, United States of America, Japan). These five Modules shall be presented in strict accordance with the format, content and numbering system delineated in details in Volume 2 B of the Notice to Applicants referred to above.
(3) \| Oblika-CTD-Evropske skupnosti se uporablja za vloge za pridobitev vseh vrst dovoljenj za promet z zdravilom, ne glede na postopek, ki se bo uporabljal (t.j. centralizirani, postopek medsebojnega priznavanja ali nacionalni) in ne glede na to, ali gre za popolno ali skrajšano vlogo. Uporablja se tudi za vse vrste zdravil, vključno z novimi kemijskimi molekulami (NCE), radiofarmacevtskimi izdelki, derivati plazme, cepivi, zdravili rastlinskega izvora, itd.	(3) \| The European Community-CTD-presentation is applicable for all types of marketing authorisation applications irrespective of the procedure to be applied (i.e. centralised, mutual recognition or national) and of whether they are based on a full or abridged application. It is also applicable for all types of products including new chemical entities (NCE), radio-pharmaceuticals, plasma derivatives, vaccines, herbal medicinal products, etc.
(4) \| Pri sestavljanju dokumentacije za vlogo za pridobitev dovoljenja za promet z zdravilom vlagatelji upoštevajo znanstvene smernice o kakovosti, varnosti in učinkovitosti zdravil za ljudi, ki jih je sprejel Odbor za lastniška zdravila (CPMP) in objavila Evropska agencija za vrednotenje zdravil (EMEA) in druge farmacevtske smernice Skupnosti, ki jih je Komisija objavila v različnih zvezkih Pravil, ki urejajo zdravila v Evropski skupnosti.	(4) \| In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
(5) \| V zvezi z delom dokumentacije o kakovosti (kemijski, farmacevtski in biološki) se uporabljajo vse monografije, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.	(5) \| With respect to the quality part (chemical, pharmaceutical and biological) of the dossier, all monographs including general monographs and general chapters of the European Pharmacopoeia are applicable.
(6) \| Postopek proizvodnje mora biti v skladu z zahtevami Direktive Komisije 91/356/EGS o določitvi načel in smernic dobre proizvodne prakse (GMP) za zdravila za ljudi ( 17 ) ter z načeli in smernicami dobre proizvodne prakse, ki jih je Komisija objavila v zvezku 4 Pravil, ki urejajo zdravila v Evropski skupnosti.	(6) \| The manufacturing process shall comply with the requirements of Commission Directive 91/356/EEC laying down the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use ( 17 ) and with the principles and guidelines on GMP, published by the Commission in The rules governing medicinal products in the European Community, Volume 4.
(7) \| V vlogo se vključijo vsi podatki, ki so pomembni za vrednotenje zadevnega zdravila, če so ugodni ali neugodni za zdravilo. Zlasti je treba navesti vse pomembne podrobnosti o vseh nepopolnih ali opuščenih farmakološko-toksikoloških ali kliničnih preskusih ali preskušanjih zdravila in/ali dokončanih preskušanjih v zvezi s terapevtskimi indikacijami, ki jih vloga ne zajema.	(7) \| All information, which is relevant to the evaluation of the medicinal product concerned, shall be included in the application, whether favourable or unfavourable to the product. In particular, all relevant details shall be given of any incomplete or abandoned pharmaco-toxicological or clinical test or trial relating to the medicinal product and/or completed trials concerning therapeutic indications not covered by the application.
(8) \| Vsa klinična preskušanja, ki se izvajajo znotraj Evropske skupnosti, morajo izpolnjevati zahteve Direktive 2001/20/ES Evropskega parlamenta in Sveta o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi ( 18 ). Da bi se med ocenjevanjem vloge upoštevala klinična preskušanja, opravljena izven Evropske skupnosti, ki pa se nanašajo na zdravila, predvidena za uporabo v Evropski skupnosti, se ta načrtujejo, izvajajo in se o njih poroča, po katerikoli zadevni dobri klinični praksi in etičnih načelih, na podlagi načel, ki so enakovredna določbam Direktive 2001/20/ES. Izvajajo se v skladu z etičnimi načeli, ki se upoštevajo, na primer, v Helsinški deklaraciji.	(8) \| All clinical trials, conducted within the European Community, must comply with the requirements of Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use ( 18 ). To be taken into account during the assessment of an application, clinical trials, conducted outside the European Community, which relate to medicinal products intended to be used in the European Community, shall be designed, implemented and reported on what good clinical practice and ethical principles are concerned, on the basis of principles, which are equivalent to the provisions of Directive 2001/20/EC. They shall be carried out in accordance with the ethical principles that are reflected, for example, in the Declaration of Helsinki.
(9) \| Neklinične (farmokološko-toksikološke) študije se izvajajo v skladu z določbami o dobri laboratorijski praksi iz Direktive Sveta 87/18/EGS o uskladitvi predpisov in administrativnih določb o uporabi načel dobre laboratorijske prakse in preverjanju uporabe načel za preskuse kemičnih snovi ( 19 ), ter 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) ( 20 ).	(9) \| Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances ( 19 ) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP) ( 20 ).
(10) \| Države članice tudi zagotovijo, da se vsi preskusi na živalih opravljajo v skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskusne in druge znanstvene namene.	(10) \| Member States shall also ensure that all tests on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes.
(11) \| Za spremljanje ocene razmerja med koristjo in tveganjem, se pristojnemu organu predložijo vsi novi podatki, ki niso v prvotni vlogi, ter vsi podatki o farmakovigilanci. Ko je zdravilo že pridobilo dovoljenje za promet, se pristojnim organom predložijo vse spremembe podatkov v dokumentaciji, v skladu z zahtevami uredb Komisije (ES) št. 1084/2003 ( 21 ) in (ES) št. 1085/2003 ( 22 ), ali, če je ustrezno, v skladu z nacionalnimi predpisi kot tudi zahtevami zvezka 9 Pravil, ki urejajo zdravila v Evropski skupnosti in jih je izdala Komisija. \| Ta priloga je razdeljena na štiri različne dele: \| — \| Del I opisuje strukturo vloge, povzetek glavnih značilnosti zdravila, označevanje, navodilo za uporabo in zahteve za obliko standardne vloge (moduli 1 do 5). \| — \| Del II omogoča odstopanje za „Posebne vloge“, to je dobro uveljavljena medicinska uporaba, bistveno podobna zdravila, zdravila z določeno kombinacijo, podobna biološka zdravila, izredne okoliščine in mešane vloge (delno bibliografske in delno lastne študije). \| — \| Del III obravnava „Podrobne zahteve za vloge“ za biološka zdravila (glavna dokumentacija o plazmi; glavna dokumentacija o antigenu cepiva), radiofarmacevtski izdelki, homeopatska zdravila, zdravila rastlinskega izvora in zdravila sirote. \| — \| Del IV obravnava „Zdravila za napredno zdravljenje“ in posebne zahteve za zdravila za gensko zdravljenje (ki uporablja človeške avtologne ali alogenske sisteme, ali ksenogenske sisteme) in zdravila za celično zdravljenje tako človeškega kot živalskega izvora in ksenogenska transplantacijska zdravila.	(11) \| In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmaco-vigilance information shall be submitted to the competent authority. After marketing authorisation has been granted, any change to the data in the dossier shall be submitted to the competent authorities in accordance with the requirements of Commission Regulations (EC) No 1084/2003 ( 21 ) and (EC) No 1085/2003 ( 22 ) of the Commission or, if relevant, in accordance with national provisions, as well as the requirements in Volume 9 of Commission publication The rules governing medicinal products in the European Community. \| This Annex is divided in four different parts: \| — \| Part I describes the application format, the summary of product characteristics, the labelling, the leaflet and presentation requirements for standard applications (Modules 1 to 5). \| — \| Part II provides derogation for ‘Specific applications’, i.e. well-established medicinal use, essentially similar products, fixed combinations, similar biological products, exceptional circumstances and mixed applications (part bibliographic and part own studies). \| — \| Part III deals with ‘Particular application requirements’ for biological medicinal products (Plasma Master File; Vaccine Antigen Master File), radio-pharmaceuticals, homeopathic medicinal products, herbal medicinal products and orphan medicinal products. \| — \| Part IV deals with ‘Advanced therapy medicinal products’ and concerns specific requirements for gene therapy medicinal products (using human autologous or allogeneic system, or xenogeneic system) and cell therapy medicinal products both of human or animal origin and xenogeneic transplantation medicinal products.
DEL I	PART I
STANDARDIZIRANE ZAHTEVE GLEDE DOKUMENTACIJE ZA PRIDOBITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM	STANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS
1. MODUL 1: ADMINISTRATIVNI PODATKI	1. MODULE 1: ADMINISTRATIVE INFORMATION
1.1 Vsebina	1.1. Table of contents
Prikaže se celotna vsebina Modulov 1 do 5 v dokumentaciji, predloženi ob vlogi za pridobitev dovoljenja za promet z zdravilom.	A comprehensive table of contents of Modules 1 to 5 of the dossier submitted for marketing authorisation application shall be presented.
1.2 Obrazec vloge	1.2. Application form
Zdravilo, ki je predmet vloge, se opredeli z imenom ter imenom zdravilne(-ih) učinkovine/učinkovin, skupaj s farmacevtsko obliko, načinom dajanja, jakostjo ter končnim pakiranjem, vključno z ovojnino.	The medicinal product, which is the subject of the application, shall be identified by name and name of the active substance(s), together with the pharmaceutical form, the route of administration, the strength and the final presentation, including packaging.
Navede se ime in naslov vlagatelja, skupaj z imenom in naslovom proizvajalcev in mest proizvodnje, vključenih v različne faze proizvodnje (vključno z proizvajalcem končnega izdelka ter proizvajalcem/proizvajalci aktivne(-ih) učinkovine/učinkovin), in kadar je to primerno, ime in naslov uvoznika.	The name and address of the applicant shall be given, together with the name and address of the manufacturers and the sites involved in the different stages of the manufacture (including the manufacturer of the finished product and the manufacturer(s) of the active substance(s)), and where relevant the name and address of the importer.
Vlagatelj opredeli vrsto vloge in navede, katere vzorce tudi prilaga, če jih.	The applicant shall identify the type of application and indicate what samples, if any, are also provided.
K administrativnim podatkom se priložijo kopije dovoljenja za proizvodnjo, kakor je določeno v členu 40, skupaj s seznamom držav, v katerih je zdravilo že pridobilo dovoljenje za promet, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členom 11, kakor so jih odobrile države članice, ter seznam držav, v katerih je vloga vložena.	Annexed to the administrative data shall be copies of the manufacturing authorisation as defined in Article 40, together with a list of countries in which authorisation has been granted, copies of all the summaries of product characteristics in accordance with Article 11 as approved by Member States and a list of countries in which an application has been submitted.
Kakor je napisano v obrazcu vloge, vlagatelji, med drugim, navedejo podrobnosti o zdravilu, ki je predmet vloge, pravno podlago za vlogo, predlaganega imetnika dovoljenja za promet z zdravilom in proizvajalca/proizvajalce, podatke o statusu zdravila sirote, znanstveni nasvet in program pediatričnega razvoja.	As outlined in the application form, the applicants shall provide, inter alia, details of the medicinal product subject of the application, the legal basis of the application, the proposed marketing authorisation holder and manufacture(s), information on orphan medicinal product status, scientific advice and paediatric development program.
1.3 Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo	1.3. Summary of product characteristics, labelling and package leaflet
1.3.1 Povzetek glavnih značilnosti zdravila	1.3.1. Summary of product characteristics
Vlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 11.	The applicant shall propose a summary of the product characteristics, in accordance with Article 11.
1.3.2 Označevanje in navodilo za uporabo	1.3.2. Labelling and package leaflet
Vlagatelj navede predlagano besedilo za stično in zunanjo ovojnino kot tudi za navodilo za uporabo. Vsa besedila so v skladu z obveznimi postavkami iz seznama v naslovu V o označevanju zdravil za ljudi (člen 63) in o navodilu za uporabo (člen 59).	A proposed labelling text for immediate and outer packaging as well as for the package leaflet shall be provided. These shall be in accordance with all mandatory items listed in Title V on the labelling of medicinal products for human use (Article 63) and on package leaflet (Article 59).
1.3.3 Osnutki in vzorci ovojnine	1.3.3. Mock-ups and specimens
Vlagatelj za zadevno zdravilo predloži vzorce in/ali osnutke stične in zunanje ovojnine, nalepk in navodil za uporabo.	The applicant shall provide specimen and/or mock-ups of the immediate and outer packaging, labels and package leaflets for the medicinal product concerned.
1.3.4 Povzetki glavnih značilnosti zdravila, odobreni v državah članicah	1.3.4. Summaries of product characteristics already approved in the Member States
K administrativnim podatkom obrazca vloge se priložijo, kadar je to primerno, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členoma 11 in 21, kakor so jih države članice že odobrile, ter seznam držav, v katerih je vloga že predložena.	Annexed to the administrative data of the application form shall be copies of all the summaries of product characteristics in accordance with Articles 11 and 21 as approved by Member States, where applicable and a list of countries in which an application has been submitted.
1.4 Podatki o strokovnjakih	1.4. Information about the experts
V skladu s členom 12(2) morajo strokovnjaki podati podrobna poročila o svojih opažanjih o dokumentih in o podrobnih podatkih, ki sestavljajo dokumentacijo za pridobitev dovoljenja za promet z zdravilom, ter zlasti o modulih 3, 4 in 5 (kemijska, farmacevtska in biološka dokumentacija, neklinična in klinična dokumentacija). Strokovnjaki obvezno obravnavajo kritične točke v zvezi s kakovostjo zdravila in raziskavami, opravljenimi na živalih in ljudeh, ter razkrijejo vse podatke, pomembne za ovrednotenje.	In accordance with Article 12 (2) experts must provide detailed reports of their observations on the documents and particulars which constitute the marketing authorisation dossier and in particular on Modules 3, 4 and 5 (chemical, pharmaceutical and biological documentation, non-clinical documentation and clinical documentation, respectively). The experts are required to address the critical points related to the quality of the medicinal product and of the investigations carried out on animals and human beings and bring out all the data relevant for evaluation.
Te zahteve se izpolnijo s predložitvijo celotnega povzetka o kakovosti, nekliničnega pregleda (podatki iz študij, opravljenih na živalih) in kliničnega pregleda, ki se vključi v modul 2 vloge za pridobitev dovoljenja za promet z zdravilom. V modulu 1 se predloži izjava, ki jo strokovnjaki podpišejo, skupaj s kratko informacijo o njihovi izobrazbi, usposobljenosti in poklicnih izkušnjah. Strokovnjaki morajo biti ustrezno strokovno in poklicno usposobljeni. Z izjavo se opredeli tudi poslovna povezava med strokovnjakom in vlagateljem.	These requirements shall be met by providing a quality overall summary, a non-clinical overview (data from studies carried out in animals) and a clinical overview that shall be located in Module 2 of the marketing authorisation application dossier. A declaration signed by the experts together with brief information on their educational background, training and occupational experience shall be presented in Module 1. The experts shall have suitable technical or professional qualifications. The professional relationship of the expert to the applicant shall be declared.
1.5 Posebne zahteve za različne vrste vlog	1.5. Specific requirements for different types of applications
Posebne zahteve za različne vrste vlog se obravnavajo v delu II te priloge.	Specific requirements for different types of applications are addressed in Part II of the present Annex.
1.6 Ocena tveganja za okolje	1.6. Environmental risk assessment
Kadar je to primerno, se v vlogo za pridobitev dovoljenja za promet z zdravilom vključi pregled ocene tveganja, kjer so ovrednotena možna tveganja za okolje zaradi uporabe in/ali odstranjevanja zdravila ter predlogi ustreznih zahtev za označevanje. Obravnavajo se tveganja za okolje, povezana s sproščanjem zdravil, ki vsebujejo ali so sestavljena iz gensko spremenjenih organizmov (GSO) v smislu člena 2 Direktive 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS ( 23 ).	Where applicable, applications for marketing authorisations shall include a risk assessment overview evaluating possible risks to the environment due to the use and/or disposal of the medicinal product and make proposals for appropriate labelling provisions. Environmental risk connected with the release of medicinal products containing or consisting of GMOs (Genetically Modified Organisms) within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of modified organisms and repealing Council Directive 90/220/EEC ( 23 ) shall be addressed.
Informacije, ki se nanašajo na tveganja za okolje, se dodajo kot dodatek k modulu 1.	Information pertaining to the environmental risk shall appear as an appendix to Module 1.
Informacije se navedejo v skladu z določbami Direktive 2001/18/ES ob upoštevanju vseh dokumentov z navodili, ki jih je Komisija objavila v zvezi z izvajanjem navedene direktive.	The information shall be presented in accordance with the provisions of Directive 2001/18/EC, taking into account any guidance documents published by the Commission in connection with the implementation of the said Directive.
Informacije sestavljajo:	The information shall consist of:
—	—
uvod,	an introduction;
—	—
izvod pisnega dovoljenja ali dovoljenj za namerno sproščanje GSO(-jev) v okolje v raziskovalne in razvojne namene v skladu z delom B Direktive 2001/18/ES,	a copy of any written consent or consents to the deliberate release into the environment of the GMO(s) for research and development purposes according to Part B of Directive 2001/18/EC;
—	—
informacije, ki se zahtevajo v prilogah II in IV Direktive 2001/18/ES, vključno z metodami detekcije in identifikacije, kot tudi enotno kodo GSO, in vsemi dodatnimi informacijami o GSO ali izdelku, ki je pomemben za ovrednotenje tveganja za okolje,	the information requested in Annexes II to IV of the Directive 2001/18/EC, including detection and identification methods as well as unique code of the GMO, plus any additional information on the GMO or the product of relevance to evaluating the environmental risk;
—	—
poročilo o oceni tveganja za okolje (ERA), pripravljeno na podlagi podatkov, opredeljenih v prilogah III in IV Direktive 2001/18/ES in v skladu s Prilogo II Direktive 2001/18/ES,	an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;
—	—
ob upoštevanju zgornjih informacij in ERA, zaključek, s katerim se predlaga ustrezna strategija obvladovanja tveganja, vključuje, kakor je ustrezno za GSO in zadevne izdelke, načrt spremljanja po začetku prodaje in opredelitev vseh posebnih podrobnih podatkov, ki jih je treba navesti v povzetku glavnih značilnosti zdravila, na ovojnini in v navodilu za uporabo,	taking into account the above information and the ERA, a conclusion which proposes an appropriate risk management strategy which includes, as relevant to the GMO and product in question, a post-market monitoring plan and the identification of any special particulars which need to appear in the Summary of Product Characteristics, labelling and package leaflet;
—	—
ustrezni ukrepi za obveščanje javnosti.	appropriate measures in order to inform the public.
Vključijo se avtorjev podpis, opremljen z datumom, podatki o avtorjevi izobrazbi, usposobljenosti in poklicnih izkušnjah, ter navedba avtorjeve povezave z vlagateljem.	A dated signature of the author, information on the author's educational, training and occupational experience, and a statement of the author's relationship with the applicant, shall be included.
2. MODUL 2: POVZETKI	2. MODULE 2: SUMMARIES
Cilj tega modula je povzeti kemijske, farmacevtske in biološke podatke, neklinične podatke in klinične podatke, podane v modulih 3, 4 in 5 dokumentacije za pridobitev dovoljenja za promet z zdravilom, ter podati poročila/preglede, opisane v členu 12 te direktive.	This Module aims to summarise the chemical, pharmaceutical and biological data, the non-clinical data and the clinical data presented in Modules 3, 4 and 5 of the dossier for marketing authorisation, and to provide the reports/overviews described in Article 12 of this Directive.
Obravnavajo in analizirajo se pomembne točke. Predložijo se povzetki dejstev vključno s prikazi v obliki preglednic. V teh poročilih se navedejo sklici na prikaze v obliki preglednic ali na podatke, vključene v glavno dokumentacijo, predloženo v modulu 3 (kemijska, farmacevtska in biološka dokumentacija), modulu 4 (neklinična dokumentacija) in modulu 5 (klinična dokumentacija).	Critical points shall be addressed and analysed. Factual summaries including tabular formats shall be provided. Those reports shall provide cross-references to tabular formats or to the information contained in the main documentation presented in Module 3 (chemical, pharmaceutical and biological documentation), Module 4 (non-clinical documentation) and Module 5 (clinical documentation).
Podatki, vključeni v modulu 2 se prikažejo v skladu s strukturo, vsebino in sistemom številčenja, opisanim v zvezku 2 Obvestila vlagateljem. Pregledi in povzetki so v skladu s tukaj določenimi temeljnimi načeli in zahtevami:	Information contained in Module 2 shall be presented in accordance with the format, content and numbering system delineated in the Volume 2 of the Notice to Applicants. The overviews and summaries shall comply with the basic principles and requirements as laid down herewith:
2.1 Celoten pregled vsebine	2.1. Overall table of contents
Modul 2 vključuje pregled vsebine znanstvene dokumentacije, predložene v modulih 2 do 5.	Module 2 shall contain a table of contents for the scientific documentation submitted in Modules 2 to 5.
2.2 Uvod	2.2. Introduction
Predložijo se podatki o farmakološki skupini, načinu delovanja in predlagani klinični uporabi zdravila, za katerega se podaja vloga za pridobitev dovoljenja za promet z zdravilom.	Information on the pharmacological class, mode of action and proposed clinical use of the medicinal product for which a marketing authorisation is requested shall be supplied.
2.3 Celoten povzetek o kakovosti zdravila	2.3. Quality overall summary
V celotnem povzetku o kakovosti zdravila se navede pregled informacij o kemijskih, farmacevtskih in bioloških podatkih.	A review of the information related to the chemical, pharmaceutical and biological data shall be provided in a quality overall summary.
Poudarijo se pomembni ključni parametri in vprašanja v zvezi z vidiki kakovosti ter upravičenost neupoštevanja ustreznih smernic v nekaterih primerih. Ta dokument upošteva obseg in pregled ustreznih podrobnih podatkov, prikazanih v modulu 3.	Key critical parameters and issues related to quality aspects shall be emphasised as well as justification in cases where the relevant guidelines are not followed. This document shall follow the scope and outline of the corresponding detailed data presented in Module 3.
2.4 Pregled eklinične dokumentacije	2.4. Non-clinical overview
Zahteva se celotna in kritična ocena nekliničnega ovrednotenja zdravila na živalih/in vitro. Vključi se obravnava in utemeljitev preskusne strategije in odmik od ustreznih smernic.	An integrated and critical assessment of the non-clinical evaluation of the medicinal product in animals/in vitro shall be required. Discussion and justification of the testing strategy and of deviation from the relevant guidelines shall be included.
Vključi se, razen pri bioloških zdravilih, ocena nečistot in razpadnih produktov skupaj z njihovimi potencialnimi farmakološkimi in toksikološkimi učinki. Obravnavajo se posledice kakršnih koli razlik v kiralnosti, kemijski obliki, in profilu nečistot med sestavino, uporabljeno v nekliničnih študijah in zdravilom, namenjenim za promet.	Except for biological medicinal products, an assessment of the impurities and degradation products shall be included along with their potential pharmacological and toxicological effects. The implications of any differences in the chirality, chemical form, and impurity profile between the compound used in the non-clinical studies and the product to be marketed shall be discussed.
Pri bioloških zdravilih se oceni primerljivost snovi, uporabljene v nekliničnih študijah, kliničnih študijah in zdravilu, namenjenem za trženje.	For biological medicinal products, comparability of material used in non-clinical studies, clinical studies, and the medicinal product for marketing shall be assessed.
Za vse nove pomožne snovi je treba izdelati posebno oceno o varnosti.	Any novel excipient shall be the subject of a specific safety assessment.
Opredelijo se lastnosti zdravila, dokazane z nekliničnimi študijami in obravnavajo se posledice ugotovitev glede varnosti zdravila za predvideno klinično uporabo za ljudi.	The characteristics of the medicinal product, as demonstrated by the non-clinical studies shall be defined and the implications of the findings for the safety of the medicinal product for the intended clinical use in human shall be discussed.
2.5 Pregled klinične dokumentacije	2.5. Clinical overview
Namen kliničnega pregleda je podati kritično analizo kliničnih podatkov, vključenih v klinični povzetek in modul 5. Navede se pristop h kliničnemu razvoju zdravila, vključno z načrtom kritične študije, odločitvami o študijah in njihovi izvedbi.	The clinical overview is intended to provide a critical analysis of the clinical data included in the clinical summary and Module 5. The approach to the clinical development of the medicinal product, including critical study design, decisions related to and performance of the studies shall be provided.
Navede se kratek pregled kliničnih ugotovitev, vključno s pomembnimi omejitvami ter ovrednotenjem koristi in tveganj na osnovi zaključkov kliničnih študij. Zahteva se obrazložitev, na kakšen način ugotovitve o učinkovitosti in varnosti podpirajo predlagani odmerek in ciljne indikacije ter ovrednotenje, kako se bo s povzetkom glavnih značilnosti zdravila in drugimi pristopi optimiziralo koristi in obvladovalo tveganja.	A brief overview of the clinical findings, including important limitations as well as an evaluation of benefits and risks based on the conclusions of the clinical studies shall be provided. An interpretation of the way the efficacy and safety findings support the proposed dose and target indications and an evaluation of how the summary of product characteristics and other approaches will optimise the benefits and manage the risks is required.
Obrazložijo se vprašanja učinkovitosti in varnosti, s katerimi so se soočali pri razvoju, ter nerešena vprašanja.	Efficacy or safety issues encountered in development and unresolved issues shall be explained.
2.6 Povzetek eklinične dokumentacije	2.6. Non-clinical summary
Navedejo se rezultati farmakoloških, farmakokinetičnih in toksikoloških študij, opravljenih na živalih/in vitro, kot pisni in v obliki preglednic prikazani povzetki dejstev v naslednjem vrstnem redu:	The results of pharmacology, pharmaco-kinetics and toxicology studies carried out in animals/in vitro shall be provided as factual written and tabulated summaries which shall be presented in the following order:
—	—
Uvod	Introduction
—	—
Farmakološki pisni povzetek	Pharmacology Written Summary
—	—
Farmakološki povzetek, prikazan v obliki preglednic	Pharmacology Tabulated Summary
—	—
Farmakološko-kinetični pisni povzetek	Pharmaco-kinetics Written Summary
—	—
Farmakokinetični povzetek, prikazan v obliki preglednic	Pharmaco-kinetics Tabulated Summary
—	—
Toksikološki pisni povzetek	Toxicology Written Summary
—	—
Toksikološki povzetek, prikazan v obliki preglednic	Toxicology Tabulated Summary.
2.7 Povzetek klinične dokumentacije	2.7. Clinical Summary
Navede se podroben povzetek dejstev kliničnih informacij o zdravilu, vključenih v modul 5. Ta vključuje rezultate biofarmacevtskih študij, kliničnih farmakoloških študij in kliničnih študij o učinkovitosti in varnosti. Zahteva se strnjen pregled posameznih študij.	A detailed, factual summary of the clinical information on the medicinal product included in Module 5 shall be provided. This shall include the results of all bio-pharmaceutics studies, of clinical pharmacology studies, and of clinical efficacy and safety studies. A synopsis of the individual studies is required.
Povzete klinične informacije se navedejo v naslednjem vrstnem redu:	Summarised clinical information shall be presented in the following order:
—	—
Povzetek biofarmacevtskih in z njimi povezanih analiznih metod	Summary of Bio-pharmaceutics and Associated Analytical Methods
—	—
Povzetek kliničnih farmakoloških študij	Summary of Clinical Pharmacology Studies
—	—
Povzetek klinične učinkovitosti	Summary of Clinical Efficacy
—	—
Povzetek klinične varnosti	Summary of Clinical Safety
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Strnjeni pregledi posameznih študij	Synopses of Individual Studies
3. MODUL 3: KEMIJSKI, FARMACEVTSKI IN BIOLOŠKI PODATKI O ZDRAVILIH, KI VSEBUJEJO KEMIČNE IN/ALI BIOLOŠKE ZDRAVILNE UČINKOVINE	3. MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS CONTAINING CHEMICAL AND/OR BIOLOGICAL ACTIVE SUBSTANCES
3.1 Struktura in oblika	3.1. Format and presentation
Splošen pregled modula 3 je, kakor sledi:	The general outline of Module 3 is as follows:
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Pregled vsebine	Table of contents
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Glavni podatki	Body of data
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Zdravilna učinkovina	Active substance
Splošni podatki	General Information
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Nomenklatura	Nomenclature
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Struktura	Structure
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Splošne lastnosti	General Properties
Proizvodnja	Manufacture
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Proizvajalec/proizvajalci	Manufacturer(s)
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Opis postopka proizvodnje in kontrol postopka	Description of Manufacturing Process and Process Controls
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Kontrola snovi	Control of Materials
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Kontrola pomembnih faz in intermediatov	Controls of Critical Steps and Intermediates
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Validacija postopka in/ali ovrednotenje	Process Validation and/or Evaluation
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Razvoj postopka proizvodnje	Manufacturing Process Development
Opis lastnosti	Characterisation
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Obrazložitev strukture in drugih značilnosti	Elucidation of Structure and other Characteristics
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Nečistote	Impurities
Kontrola zdravilne učinkovine	Control of Active Substance
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Specifikacija	Specification
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Analizni postopki	Analytical Procedures
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Validacija analiznih postopkov	Validation of Analytical Procedures
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Analize serij	Batch Analyses
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Utemeljitev specifikacije	Justification of Specification
Referenčni standardi ali snovi	Reference Standards or Materials
Sistem zapiranja vsebnika	Container Closure System
Stabilnost	Stability
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Povzetek stabilnosti in zaključki	Stability Summary and Conclusions
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Protokol stabilnosti po odobritvi in zaveza o spremljanju stabilnosti	Post-approval Stability Protocol and Stability Commitment
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Podatki o stabilnosti	Stability Data
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Končni izdelek	Finished Medicinal Product
Opis in sestava zdravila	Description and Composition of the Medicinal Product
Farmacevtski razvoj	Pharmaceutical Development
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Sestavine zdravila	Components of the Medicinal Product
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Zdravilna učinkovina	Active Substance
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Pomožne snovi	Excipients
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Zdravilo	Medicinal Product
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Razvoj formulacije	Formulation Development
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Presežki	Overages
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Fizikalno kemijske in biološke lastnosti	Physicochemical and Biological Properties
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Razvoj postopka proizvodnje	Manufacturing Process Development
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Sistem zapiranja vsebnika	Container Closure System
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Mikrobiološki parametri	Microbiological Attributes
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Združljivost	Compatibility
Proizvodnja	Manufacture
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Proizvajalec/proizvajalci	Manufacturer(s)
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Sestavnica serije	Batch Formula
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Opis postopka proizvodnje in kontrole postopka	Description of Manufacturing Process and Process Controls
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Kontrola pomembnih faz in intermediatov	Controls of Critical Steps and Intermediates
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Validacija postopka in/ali ovrednotenje	Process Validation and/or Evaluation
Kontrola pomožnih snovi	Control of Excipients
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Specifikacije	Specifications
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Analizni postopki	Analytical Procedures
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Validacija analiznih postopkov	Validation of Analytical Procedures
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Utemeljitev specifikacij	Justification of Specifications
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Pomožne snovi človeškega ali živalskega izvora	Excipients of Human or Animal Origin
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Nove pomožne snovi	Novel Excipients
Kontrola končnega izdelka	Control of Finished Medicinal Product
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Specifikacija(-e)	Specification(s)
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Analizni postopki	Analytical Procedures
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Validacija analiznih postopkov	Validation of Analytical Procedures
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Analize serije	Batch Analyses
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Opis lastnosti nečistot	Characterisation of Impurities
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Utemeljitev specifikacije/specifikacij	Justification of Specification(s)
Referenčni standardi ali snovi	Reference Standards or Materials
Sistem zapiranja vsebnika	Container Closure System
Stabilnost	Stability
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Povzetek stabilnosti in zaključki	Stability Summary and Conclusion
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Protokol stabilnosti po odobritvi in zaveza o spremljanju stabilnosti	Post-approval Stability Protocol and Stability Commitment
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Podatki o stabilnosti	Stability Data
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Dodatki	Appendices
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Objekti in oprema (samo za biološka zdravila)	Facilities and Equipment (Biological Medicinal Products only)
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Ovrednotenje varnosti glede prisotnosti naključnih snovi	Adventitious Agents Safety Evaluation
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Pomožne snovi	Excipients
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Dodatne informacije Evropske skupnosti	European Community Additional Information
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Program validacije postopka za zdravilo	Process Validation Scheme for the Medicinal Product
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Medicinski pripomoček	Medical Device
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Potrdilo(-a) o ustreznosti	Certificate(s) of Suitability
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Zdravila, ki vsebujejo ali za katera se v postopku proizvodnje uporabljajo snovi živalskega in/ali človeškega izvora (postopek TSE)	Medicinal products containing or using in the manufacturing process materials of animal and/or human origin (TSE procedure)
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Navedba literature	Literature References
3.2 Vsebina: temeljna načela in zahteve	3.2. Content: basic principles and requirements
(1) \| Kemijski, farmacevtski in biološki podatki, ki se predložijo za zdravilno(-e) učinkovino(-e) in za končni izdelek, vključujejo vse pomembne informacije o: razvoju, postopku proizvodnje, opisu lastnosti in lastnostih, postopkih in zahtevah kontrole kakovosti, stabilnosti ter opisu sestave in oblike pakiranja končnega zdravila.	(1) \| The chemical, pharmaceutical and biological data that shall be provided shall include for the active substance(s) and for the finished medicinal product all of relevant information on: the development, the manufacturing process, the characterisation and properties, the quality control operations and requirements, the stability as well as a description of the composition and presentation of the finished medicinal product.
(2) \| Navedeta se dva glavna sklopa informacij, ki obravnavata zdravilno(-e) učinkovino(-e) in končni izdelek.	(2) \| Two main sets of information shall be provided, dealing with the active substance(s) and with the finished medicinal product, respectively.
(3) \| V tem modulu se dodatno podajo podrobni podatki o vhodnih snoveh in surovinah, ki se uporabljajo v postopkih proizvodnje aktivne(-ih) učinkovine/učinkovin, ter o pomožnih snoveh, vključenih v formulacijo končnega izdelka.	(3) \| This Module shall in addition supply detailed information on the starting and raw materials used during the manufacturing operations of the active substance(s) and on the excipients incorporated in the formulation of the finished medicinal product.
(4) \| Vsi postopki in metode, ki se uporabljajo za proizvodnjo in kontrolo zdravilne učinkovine in končnega izdelka, se dovolj podrobno opišejo, tako da jih je mogoče ponoviti v kontrolnih preskusih, ki se izvajajo na zahtevo pristojnega organa. Vsi preskusni postopki ustrezajo stanju trenutnega znanstvenega napredka in se jih validira. Predložijo se rezultati validacijskih študij. Pri postopkih preskušanja, vključenih v Evropsko farmakopejo, se ta opis nadomesti z ustreznim podrobnim sklicevanjem na monografijo(-e) in splošno(-a) poglavje(-a).	(4) \| All the procedures and methods used for manufacturing and controlling the active substance and the finished medicinal product shall be described in sufficient details to enable them to be repeated in control tests, carried out at the request of the competent authority. All test procedures shall correspond to the state of scientific progress at the time and shall be validated. Results of the validation studies shall be provided. In the case of test procedures included in the European Pharmacopoeia, this description shall be replaced by the appropriate detailed reference to the monograph(s) and general chapter(s).
(5) \| Monografije Evropske farmakopeje se uporabljajo za vse snovi, pripravke in farmacevtske oblike, ki so v njej navedene. Pri ostalih snoveh pa vsaka država članica lahko zahteva upoštevanje njene nacionalne farmakopeje. \| Kadar je vhodna snov v Evropski farmakopeji ali v farmakopeji države članice pripravljena po postopku, pri katerem bi lahko nastale nečistote, ki niso nadzorovane z monografijo farmakopeje, je te nečistote ter njihove najvišje dopustne meje vsebnosti treba navesti ter opisati ustrezen preskusni postopek. V primerih, kadar specifikacija, ki jo vsebuje monografija Evropske farmakopeje ali nacionalna farmakopeja države članice, ne zadošča za zagotavljanje kakovosti snovi, pristojni organi lahko zahtevajo ustreznejše specifikacije od imetnika dovoljenja za promet z zdravilom. Pristojni organi obvestijo organe, odgovorne za zadevno farmakopejo. Imetnik dovoljenja za promet z zdravilom organom zadevne farmakopeje predloži podrobnosti o domnevnih pomanjkljivostih ter o dodatnih uporabljenih specifikacijah. \| Pri analiznih postopkih, vključenih v Evropsko farmakopejo, se ta opis v vsakem ustreznem oddelku nadomesti z ustreznim podrobnim sklicevanjem na monografijo(-e) in splošno(-a) poglavje(-a).	(5) \| The monographs of the European Pharmacopoeia shall be applicable to all substances, preparations and pharmaceutical forms appearing in it. In respect of other substances, each Member State may require observance of its own national pharmacopoeia. \| However, where a material in the European Pharmacopoeia or in the pharmacopoeia of a Member State has been prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits must be declared and a suitable test procedure must be described. In cases where a specification contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State might be insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the marketing authorisation holder. The competent authorities shall inform the authorities responsible for the pharmacopoeia in question. The marketing authorisation holder shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied. \| In the case of analytical procedures included in the European Pharmacopoeia, this description shall be replaced in each relevant section by the appropriate detailed reference to the monograph(s) and general chapter(s).
(6) \| Kadar vhodne snovi ali surovine, zdravilna(-e) učinkovina(-e) ali pomožna(-e) snov(-i) niso opisane v Evropski farmakopeji ali v farmakopeji države članice, je sprejemljiva skladnost z monografijo farmakopeje tretje države članice. V takih primerih vlagatelj predloži kopijo monografije skupaj z validacijo analiznih postopkov, ki jih monografija vsebuje, ter prevod, kadar je to primerno.	(6) \| In case where starting and raw materials, active substance(s) or excipient(s) are described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the applicant shall submit a copy of the monograph accompanied by the validation of the analytical procedures contained in the monograph and by a translation where appropriate.
(7) \| Kadar so zdravilna učinkovina in/ali surovina in vhodna snov ali pomožna(-e) snov(-i) predmet monografije Evropske farmakopeje, vlagatelj lahko zaprosi za certifikat o ustreznosti, da ga, kadar ga izda Evropska direkcija za kakovost zdravil (EDQM), predloži v ustreznem oddelku tega modula. Šteje se, da navedeni certifikati ustreznosti monografiji Evropske farmakopeje nadomeščajo ustrezne podatke ustreznih delov, opisanih v tem modulu. Proizvajalec poda pisno zagotovilo vlagatelju, da se postopek proizvodnje ni spreminjal od izdaje certifikata o ustreznosti s strani Evropske direkcije za kakovost zdravil.	(7) \| Where the active substance and/or a raw and starting material or excipient(s) are the subject of a monograph of the European Pharmacopoeia, the applicant can apply for a certificate of suitability that, where granted by the European Directorate for the Quality of Medicines, shall be presented in the relevant section of this Module. Those certificates of suitability of the monograph of the European Pharmacopoeia are deemed to replace the relevant data of the corresponding sections described in this Module. The manufacturer shall give the assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines.
(8) \| Za dobro opredeljeno zdravilno učinkovino, proizvajalec zdravilne učinkovine ali vlagatelj lahko poskrbita za \| (i) \| podroben opis postopka proizvodnje; \| (ii) \| kontrolo kakovosti med proizvodnjo; in \| (iii) \| validacijo postopka, \| ki jih proizvajalec zdravilne učinkovine v ločenem dokumentu predloži neposredno pristojnim organom kot glavno dokumentacijo o zdravilni učinkovini. \| V tem primeru proizvajalec vlagatelja oskrbi z vsemi podatki, ki jih ta potrebuje, da lahko prevzame odgovornost za zdravilo. Proizvajalec vlagatelju pisno potrdi, da zagotavlja konsistentnost med serijami, ter da ne bo spreminjal postopka proizvodnje ali specifikacij, ne da bi o tem obvestil vlagatelja. Dokumenti in podrobni podatki, priloženi predlogu za tovrstno spremembo, se predložijo pristojnim organom; navedeni dokumenti in podrobnosti se predložijo tudi vlagatelju, če zadevajo odprti del glavne dokumentacije o zdravilni učinkovini.	(8) \| For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the \| (i) \| detailed description of the manufacturing process, \| (ii) \| quality control during manufacture, and \| (iii) \| process validation \| to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File. \| In this case, the manufacturer shall, however, provide the applicant with all of the data, which may be necessary for the latter to take responsibility for the medicinal product. The manufacturer shall confirm in writing to the applicant that he shall ensure batch to batch consistency and not modify the manufacturing process or specifications without informing the applicant. Documents and particulars supporting the application for such a change shall be supplied to the competent authorities; these documents and particulars will be also supplied to the applicant when they concern the open part of the active substance master file.
(9) \| Posebni ukrepi za preprečevanje prenašanja spongiformnih encefalopatij (snovi, ki izvirajo iz prežvekovalcev): pri vsaki fazi postopka proizvodnje mora vlagatelj dokazati skladnost uporabljenih snovi z Navodili o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili na najmanjšo možno mero, ter v skladu z vsemi dopolnili navodil, ki jih je Komisija izdala v Uradnem listu Evropske unije. Skladnost z navedenimi navodili je po možnosti mogoče dokazati s predložitvijo certifikata ustreznosti pripadajoči monografiji Evropske farmakopeje, ki ga je izdala Evropska direkcija za kakovost zdravil, ali s predložitvijo znanstvenih podatkov, ki to skladnost dokazujejo.	(9) \| Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies (materials from ruminant origin): at each step of the manufacturing process, the applicant must demonstrate the compliance of the materials used with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union. Demonstration of compliance with the said Note for Guidance can be done by submitting either, preferably a certificate of suitability to the relevant monograph of the European Pharmacopoeia that has been granted by the European Directorate for the Quality of Medicines or by the supply of scientific data to substantiate this compliance.
(10) \| Za prisotnost naključnih snovi se predložijo podatki, ki ocenjujejo tveganje glede na možno onesnaženje z naključnimi snovmi, če so nevirusne ali virusne, kakor je določeno v ustreznih smernicah kot tudi ustrezni splošni monografiji in splošnem poglavju Evropske farmakopeje.	(10) \| For adventitious agents, information assessing the risk with respect to potential contamination with adventitious agents, whether they are non-viral or viral, as laid down in relevant guidelines as well as in relevant general monograph and general chapter of the European Pharmacopoeia, shall be provided.
(11) \| Primerno podrobno se opišejo vse posebne naprave in oprema, ki se lahko uporabljajo v katerikoli fazi postopka proizvodnje in kontrolnih postopkih zdravila.	(11) \| Any special apparatus and equipment, which may be used at any stage of the manufacturing process and control operations of the medicinal product, shall be described in adequate details.
▼M13	▼M13
(12) \| Če v skladu z drugim pododstavkom člena 1(8) ali drugim pododstavkom člena 1(9) Uredbe (EU) 2017/745 Evropskega parlamenta in Sveta ( 24 ) izdelek ureja ta direktiva, dokumentacija za pridobitev dovoljenja za promet vsebuje, če so na voljo, rezultate ugotavljanja skladnosti tistega dela, ki šteje za pripomoček, z ustreznimi splošnimi zahtevami o varnosti in učinkovitosti iz Priloge I k navedeni uredbi, ki so navedeni v proizvajalčevi izjavi EU o skladnosti ali ustreznem certifikatu, ki ga je izdal priglašeni organ, o izdaji dovoljenja proizvajalcu, da namesti oznako CE na medicinski pripomoček. \| Če dokumentacija ne vsebuje rezultatov ocene skladnosti iz prvega pododstavka in kadar mora biti pri ugotavljanju skladnosti pripomočka, če se uporablja ločeno, v skladu z Uredbo (EU) 2017/745 vključen priglašeni organ, organ od vložnika zahteva, da predloži mnenje o skladnosti tistega dela, ki se šteje za pripomoček, z ustreznimi splošnimi zahtevami o varnosti in učinkovitosti iz Priloge I k navedeni uredbi, ki ga je izdal priglašeni organ, imenovan v skladu z navedeno uredbo za zadevno vrsto pripomočka.	(12) \| Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council ( 24 ), a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device. \| If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.
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3.2.1 \| Zdravilna(-e) učinkovina(-e) \| 3.2.1.1 Splošni podatki in podatki o vhodnih snoveh in surovinah \| (a) \| Predložijo se podatki o nomenklaturi zdravilne učinkovine, vključno s priporočenim mednarodnim nezaščitenim imenom (INN), imenom iz Evropske farmakopeje, če je potrebno, ter kemijskim(-i) imenom(-i). \| Navede se strukturna formula, vključno z relativno in absolutno stereokemijo, molekulsko formulo in relativno molsko maso. Pri biotehnoloških zdravilih se navede, če je to primerno, shematično zaporedje aminokislin in relativna molska masa. \| Predloži se seznam fizikalno kemijskih in drugih ustreznih lastnosti zdravilne učinkovine, vključno z biološko aktivnostjo pri bioloških zdravilih. \| (b) \| V tej prilogi so vhodne snovi vse snovi, iz katerih se proizvaja zdravilna učinkovina ali se iz njih ekstrahira. \| Pri bioloških zdravilih so vhodne snovi vse snovi biološkega izvora, kot so mikroorganizmi, organi in tkiva rastlinskega ali živalskega izvora, celice ali tekočine (vključno s krvjo ali plazmo) človeškega ali živalskega izvora in biotehnološki celični konstrukti (celični substrati, če so rekombinantni ali ne, vključno s primarnimi celicami). \| Biološko zdravilo je zdravilo, čigar zdravilna učinkovina je biološka snov. Biološka snov je snov, ki se proizvaja ali ekstrahira iz biološkega vira in za opis lastnosti in določitev kakovosti potrebuje kombinacijo fizikalno kemijskega biološkega preskušanja, skupaj s postopkom proizvodnje in kontrolo postopka. Za biološka zdravila se štejejo: imunološka zdravila in zdravila, pridobljena iz človeške krvi in človeške plazme, kakor so opredeljena v odstavkih (4) in (10) člena 1; zdravila, ki spadajo v področje dela A Priloge k Uredbi (EGS) št. 2309/93; zdravila za napredno zdravljenje, kakor so opredeljena v delu IV te priloge. \| Vse ostale snovi, ki se uporabljajo za proizvodnjo ali ekstrahiranje zdravilne(-ih) učinkovine/učinkovin, iz katerih pa se zdravilna učinkovina neposredno ne pridobiva, kakor so reagenti, gojišča, plodovni telečji serum, dodatki in pufri, ki se uporabljajo pri kromatografiji, itd., poznane kot surovine. \| 3.2.1.2 Postopek proizvodnje zdravilne(-ih) učinkovine/učinkovin \| (a) \| Opis postopka proizvodnje zdravilne učinkovine je vlagateljeva zaveza za proizvodnjo zdravilne učinkovine. Za primeren opis postopka proizvodnje in kontrol postopka se predložijo ustrezne informacije, kakor je določeno v smernicah, ki jih je objavila Agencija. \| (b) \| Navede se seznam vseh snovi, potrebnih za proizvodnjo zdravilne(-ih) učinkovine/učinkovin, ter opredeli, kje v postopku se posamezne snovi uporabljajo. Predložijo se podatki o kakovosti in kontroli teh snovi. Navedejo se podatki, ki dokazujejo, da snovi izpolnjujejo standarde, ki ustrezajo njihovi predvideni uporabi. \| Navede se seznam surovin in dokumentira njihova kakovost ter kontrole. \| Navede se ime, naslov in odgovornost vsakega proizvajalca, vključno s pogodbeniki, in vsako predlagano mesto proizvodnje ali objekt, vključen v proizvodnjo in preskušanje. \| (c) \| Za biološka zdravila veljajo naslednje dodatne zahteve. \| Opiše in dokumentira se izvor in zgodovina vhodnih snovi. \| Glede posebnih ukrepov za preprečevanje prenosa živalskih spongiformnih encefalopatij mora vlagatelj dokazati skladnost zdravilne učinkovine z Navodili o zmanjšanju tveganja prenosa živalske spongiformne encefalopatije z zdravilom na najmanjšo možno mero, ter z vsemi dopolnili navodil, ki jih je Komisija izdala v Uradnem listu Evropske skupnosti. \| Pri uporabi celičnih bank se prikaže, da so lastnosti celic ostale nespremenjene v času prenosa v proizvodnjo in pozneje. \| Matični materiali, celične banke, zbiri seruma ali plazme in drugi materiali biološkega izvora, in kadarkoli je to mogoče, izvorni materiali, iz katerih se te snovi pridobivajo, se preskusijo na prisotnost naključnih snovi. \| Če je prisotnost potencialno patogenih naključnih snovi neizogibna, se material uporablja samo, če nadaljnja obdelava zagotavlja njihovo odstranitev in/ali inaktivacijo, kar se validira. \| Kadarkoli je to mogoče, proizvodnja cepiva temelji na sistemu matične serije ter na vzpostavljenih celičnih bankah. Pri bakterijskih in virusnih cepivih se lastnosti patogenih mikrobov prikažejo na matičnem materialu. Pri živih cepivih pa se stabilnost oslabitvenih lastnosti prikaže na matičnem materialu; če ta dokaz ne zadošča, se oslabitvene lastnosti prikažejo tudi v fazi proizvodnje. \| Pri zdravilih, pridobljenih iz človeške krvi ali plazme se v skladu z določbami iz dela III te priloge opišejo in dokumentirajo izvor ter merila in postopki za zbiranje, prevoz in shranjevanje vhodne snovi. \| Opišejo se proizvodni objekti in oprema. \| (d) \| Predložijo se, kakor je ustrezno, preskusi in merila sprejemljivosti, izvedeni pri vsaki pomembni fazi, podatki o kakovosti in kontroli intermediatov in študije postopka validacije in/ali ovrednotenja. \| (e) \| Če je prisotnost potencialno patogenih naključnih snovi neizogibna, se snov uporablja samo, če nadaljnja obdelava zagotavlja njihovo odstranitev in/ali inaktivacijo, to pa se validira v oddelku, ki obravnava ovrednotenje virusne varnosti. \| (f) \| Predloži se opis in razprava o pomembnih spremembah postopka proizvodnje med razvojem in/ali mesta proizvodnje zdravilne učinkovine. \| 3.2.1.3 Lastnosti zdravilne(-ih) učinkovine/učinkovin \| Navedejo se podatki, ki pojasnjujejo sestavo in druge lastnosti zdravilne(-ih) učinkovine/učinkovin. \| Predložijo se potrditev sestave zdravilne(-ih) učinkovine/učinkovin na osnovi fizikalno kemijskih in/ali imunološko kemijskih in/ali bioloških metod, ter podatki o nečistotah. \| 3.2.1.4 Kontrola zdravilne(-ih) učinkovine/učinkovin \| Predložijo se podrobni podatki o specifikacijah, uporabljenih pri rednih kontrolah zdravilne(-ih) učinkovine/učinkovin, utemeljitev za izbiro teh specifikacij, analizne metode in ter njihova validacija. \| Predložijo se rezultati kontrol, izvedenih na posameznih serijah, proizvedenih med razvojem. \| 3.2.1.5 Referenčni standardi ali snovi \| Opredelijo in podrobno se opišejo referenčni pripravki in standardi. Kjer je ustrezno, se uporablja kemična in biološka referenčna snov Evropske farmakopeje. \| 3.2.1.6 Vsebnik in sistem zapiranja zdravilne učinkovine \| Predložijo se opis vsebnika in sistema(-ov) zapiranja ter njihove specifikacije. \| 3.2.1.7 Stabilnost zdravilne(-ih) učinkovine/učinkovin \| (a) \| Izdelajo se povzetki vrst opravljenih študij, uporabljenih protokolov in rezultatov študij \| (b) \| V ustrezni strukturi se prikažejo podrobni rezultati študij stabilnosti, vključno s podatki o analiznih postopkih, uporabljenih za pridobitev podatkov in validacijo teh postopkov \| (c) \| Predložita se protokol o stabilnosti, potem ko je zdravilo že dobilo dovoljenje za promet, ter zaveza o spremljanju stabilnosti.	3.2.1. \| Active substance(s) \| 3.2.1.1. General information and information related to the starting and raw materials \| a) \| Information on the nomenclature of the active substance shall be provided, including recommended International Non-proprietary Name (INN), European Pharmacopoeia name if relevant, chemical name(s). \| The structural formula, including relative and absolute stereo-chemistry, the molecular formula, and the relative molecular mass shall be provided. For biotechnological medicinal products if appropriate, the schematic amino acid sequence and relative molecular mass shall be provided. \| A list shall be provided of physicochemical and other relevant properties of the active substance, including biological activity for biological medicinal products. \| b) \| For the purposes of this Annex, starting materials shall mean all the materials from which the active substance is manufactured or extracted. \| For biological medicinal products, starting materials shall mean any substance of biological origin such as micro-organisms, organs and tissues of either plant or animal origin, cells or fluids (including blood or plasma) of human or animal origin, and biotechnological cell constructs (cell substrates, whether they are recombinant or not, including primary cells). \| A biological medicinal product is a product, the active substance of which is a biological substance. A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control. The following shall be considered as biological medicinal products: immunological medicinal products and medicinal products derived from human blood and human plasma as defined, respectively in paragraphs (4) and (10) of Article 1; medicinal products falling within the scope of Part A of the Annex to Regulation (EEC) No 2309/93; advanced therapy medicinal products as defined in Part IV of this Annex. \| Any other substances used for manufacturing or extracting the active substance(s) but from which this active substance is not directly derived, such as reagents, culture media, foetal calf serum, additives, and buffers involved in chromatography, etc. are known as raw materials. \| 3.2.1.2. Manufacturing process of the active substance(s) \| a) \| The description of the active substance manufacturing process represents the applicant's commitment for the manufacture of the active substance. To adequately describe the manufacturing process and process controls, appropriate information as laid down in guidelines published by the Agency shall be provided. \| b) \| All materials needed in order to manufacture the active substance(s) shall be listed, identifying where each material is used in the process. Information on the quality and control of these materials shall be provided. Information demonstrating that materials meet standards appropriate for their intended use shall be provided. \| Raw materials shall be listed and their quality and controls shall also be documented. \| The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing shall be provided. \| c) \| For biological medicinal products, the following additional requirements shall apply. \| The origin and history of starting materials shall be described and documented. \| Regarding the specific measures for the prevention of the Transmission of animal Spongiform Encephalopathies, the applicant must demonstrate that the active substance complies with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union. \| When cell banks are used, the cell characteristics shall be shown to have remained unchanged at the passage level used for the production and beyond. \| Seed materials, cell banks, pools of serum or plasma and other materials of biological origin and, whenever possible, the materials from which they are derived shall be tested for adventitious agents. \| If the presence of potentially pathogenic adventitious agents is inevitable, the corresponding material shall be used only when further processing ensures their elimination and/or inactivation, and this shall be validated. \| Whenever possible, vaccine production shall be based on a seed lot system and on established cell banks. For bacterial and viral vaccines, the characteristics of the infectious agent shall be demonstrated on the seed. In addition, for live vaccines, the stability of the attenuation characteristics shall be demonstrated on the seed; if this proof is not sufficient, the attenuation characteristics shall also be demonstrated at the production stage. \| For medicinal products derived from human blood or plasma, the origin and the criteria and procedures for collection, transportation and storage of the starting material shall be described and documented in accordance with provisions laid down in Part III of this Annex. \| The manufacturing facilities and equipment shall be described. \| d) \| Tests and acceptance criteria carried out at every critical step, information on the quality and control of intermediates and process validation and/or evaluation studies shall be provided as appropriate. \| e) \| If the presence of potentially pathogenic adventitious agents is inevitable, the correspondent material shall be used only when further processing ensures their elimination and/or inactivation and this shall be validated in the section dealing with viral safety evaluation. \| f) \| A description and discussion of the significant changes made to the manufacturing process during development and/or manufacturing site of the active substance shall be provided. \| 3.2.1.3. Characterisation of the active substance(s) \| Data highlighting the structure and other characteristics of the active substance(s) shall be provided. \| Confirmation of the structure of the active substance(s) based on any physico-chemical and/or immuno-chemical and/or biological methods, as well as information on impurities shall be provided. \| 3.2.1.4. Control of active substance(s) \| Detailed information on the specifications used for routine control of active substance(s), justification for the choice of these specifications, methods of analysis and their validation shall be provided. \| The results of control carried out on individual batches manufactured during development shall be presented. \| 3.2.1.5. Reference standards or materials \| Reference preparations and standards shall be identified and described in detail. Where relevant, chemical and biological reference material of the European Pharmacopoeia shall be used. \| 3.2.1.6. Container and closure system of the active substance \| A description of the container and the closure system(s) and their specifications shall be provided. \| 3.2.1.7. Stability of the active substance (s) \| a) \| The types of studies conducted, protocols used, and the results of the studies shall be summarised \| b) \| Detailed results of the stability studies, including information on the analytical procedures used to generate the data and validation of these procedures shall be presented in an appropriate format \| c) \| The post authorisation stability protocol and stability commitment shall be provided
3.2.2 \| Končni izdelek \| 3.2.2.1 Opis in sestava končnega izdelka \| Predloži se opis končnega izdelka in njegova sestava. Podatki vključujejo opis farmacevtske oblike in sestave z vsemi sestavinami končnega izdelka, njihove količine na enoto, funkcijo sestavin: \| — \| zdravilne(-ih) učinkovine/učinkovin, \| — \| sestavine/sestavin pomožnih snovi, ne glede na njihovo vrsto ali uporabljeno količino, vključno z barvili, konzervansi, dodatki, stabilizatorji, zgoščevalci, emulgatorji, snovmi za izboljšanje okusa in aromami itd., \| — \| sestavin zunanjih delov zdravil, predvidenih, da jih bolnik zaužije ali prejme na kakšen drug način (trdih kapsul, mehkih kapsul, rektalnih kapsul, obloženih tablet, filmsko obloženih tablet, itd.), \| — \| ti podrobni podatki se dopolnijo z vsemi pomembnimi podatki o vrsti vsebnika in, kadar je primerno, o načinu zapiranja vsebnika, skupaj s podrobnostmi o pripomočkih, s katerimi se zdravilo uporablja ali daje, in se izdajajo skupaj z zdravilom. \| „Običajni strokovni izrazi“, ki se uporabljajo pri opisovanju sestavin zdravil, so, ne glede na uporabo drugih določb člena 8(3)(c): \| — \| pri snoveh, ki so navedene v Evropski farmakopeji ali, če ne v tej, v farmakopeji ene od držav članic, glavni naslov v glavi zadevne monografije, s sklicem na zadevno farmakopejo, \| — \| pri ostalih snoveh, mednarodno nelastniško ime (INN), ki ga priporoča Svetovna zdravstvena organizacija, ali če tega ni, natančno znanstveno poimenovanje; snovi, ki nimajo mednarodnega nelastniškega imena ali natančnega znanstvenega imena, se opišejo z navedbo, kako in iz česa so bile pripravljene in, kadar je to primerno, dopolnijo z vsemi drugimi pomembnimi podrobnostmi, \| — \| pri barvilih, označenih s številom „E“, ki jim je bilo dodeljeno v Direktivi Sveta 78/25/EGS z dne 12. decembra 1977 o približevanju zakonov držav članic v zvezi z barvili, ki se lahko dodajajo zdravilom ( 25 ) in/ali v Direktivi Evropskega parlamenta in Sveta 94/36/ES z dne 30. junija 1994 o barvilih za uporabo v živilih ( 26 ). \| Za navedbo „količinske sestave“ zdravilne učinkovine/zdravilnih učinkovin končnih izdelkov je, odvisno od zadevne farmacevtske oblike, treba navesti maso ali število enot biološke aktivnosti na enoto odmerka ali enoto mase ali prostornine za vsako zdravilno učinkovino. \| Zdravilne učinkovine, ki so prisotne v obliki zmesi ali derivatov, se navedejo količinsko z njihovo skupno maso in, če je potrebno ali primerno, z maso aktivnega dela ali delov molekule. \| Pri zdravilih, ki vsebujejo zdravilno učinkovino, ki je prvič predmet vloge za pridobitev dovoljenja za promet z zdravilom v katerikoli državi članici, se navedba količine zdravilne učinkovine, ki je sol ali hidrat, sistematično izrazi glede na maso aktivnega dela ali delov molekule. Pri vseh zdravilih, ki pozneje pridobijo dovoljenje za promet v državah članicah, se količinska sestava za isto zdravilno učinkovino navede na enak način. \| Enote biološke aktivnosti se uporabljajo za učinkovine, ki jih molekularno ni mogoče opredeliti. Če je Svetovna zdravstvena organizacija opredelila mednarodno enoto biološke aktivnosti, se ta uporablja. Če mednarodna enota ni opredeljena, se enote biološke aktivnosti izrazijo tako, da dajejo nedvoumno informacijo o aktivnosti učinkovin in, kadar je to uporabno, s pomočjo enot Evropske farmakopeje. \| 3.2.2.2 Farmacevtski razvoj \| To poglavje obravnava podatke o razvojnih študijah, ki se izvedejo zaradi dokazovanja, da so farmacevtska oblika, formulacija, postopek proizvodnje, sistem zapiranja vsebnika, mikrobiološki parametri in navodila za uporabo primerni za predvideno uporabo, navedeno v vlogi za pridobitev dovoljenja za promet z zdravilom. \| Študije, opisane v tem poglavju, se razlikujejo od običajnih kontrolnih preskusov, ki se izvajajo po specifikacijah. Opredelijo in opišejo se kritični parametri formulacije in parametri postopka proizvodnje, ki lahko vplivajo na ponovljivost serije, obnašanje in kakovost zdravila. Za dodatne spremljajoče podatke se, kadar je to primerno, navedejo sklici na ustrezna poglavja modula 4 (poročila o nekliničnih študijah) in modula 5 (poročila o kliničnih študijah) vloge za pridobitev dovoljenja za promet z zdravilom. \| (a) \| Dokumentira se združljivost zdravilne učinkovine s pomožnimi snovmi, pa tudi ključne fizikalno kemijske lastnosti zdravilne učinkovine, ki lahko vplivajo na obnašanje končnega izdelka, ali medsebojna združljivost različnih zdravilnih učinkovin, če gre za kombinirana zdravila. \| (b) \| Dokumentira se izbira pomožnih snovi, zlasti tistih, ki se nanašajo na njihove funkcije in koncentracijo. \| (c) \| Predloži se opis razvoja končnega izdelka ob upoštevanju predlaganega načina dajanja in uporabe. \| (d) \| Za vse presežke v formulaciji(-ah) je potebna utemeljitev. \| (e) \| Kar zadeva fizikalno kemijske in biološke lastnosti, se obravnavajo in dokumentirajo vsi parametri v zvezi z obnašanjem končnega izdelka. \| (f) \| Predložijo se izbira in optimizacija postopka proizvodnje ter razlike med postopkom(-i) proizvodnje, ki se uporablja(-jo) za proizvodnjo ključnih kliničnih serij, ter postopkom, ki se uporablja za proizvodnjo predlaganega končnega izdelka. \| (g) \| Dokumentira se ustreznost vsebnika in sistema zapiranja, ki se uporablja za shranjevanje, odpremo in uporabo končnega izdelka. Morda je treba upoštevati možno interakcijo med zdravilom in vsebnikom. \| (h) \| Mikrobiološki parametri farmacevtske oblike v zvezi z nesterilnimi in sterilnimi izdelki so v skladu z Evropsko farmakopejo in se dokumentirajo, kakor je v njej predpisano. \| (i) \| Za predložitev ustreznih podatkov, ki so v pomoč pri označevanju, se dokumentira združljivost končnega izdelka s topilom(-i) za rekonstitucijo ali pripomočki za odmerjanje. \| 3.2.2.3 Postopek proizvodnje končnega izdelka \| (a) \| Opis postopka proizvodnje, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(d), je zasnovan tako, da daje ustrezen strnjen pregled vrste uporabljenih delovnih postopkov. \| V ta namen opis vsebuje vsaj: \| — \| navedbo različnih faz proizvodnje, vključno s kontrolami postopka in ustreznimi merili sprejemljivosti tako, da se lahko naredi ocena, ali bi uporabljeni delovni postopki za proizvodnjo farmacevtske oblike lahko povzročili neželeno spremembo pri sestavinah, \| — \| v primeru neprekinjene proizvodnje, vse podrobnosti o previdnostnih ukrepih, da se zagotovi homogenost končnega izdelka, \| — \| poskusne študije, ki validirajo postopek proizvodnje, kadar se uporablja nestandarden postopek proizvodnje ali kadar je pomemben za izdelek, \| — \| pri sterilnih zdravilih, podrobnosti o uporabljenih postopkih sterilizacije in/ali aseptičnih postopkih, \| — \| podrobna sestava serije. \| Navede se ime, naslov in odgovornost vsakega proizvajalca, vključno s pogodbeniki in vsako predlagano mesto proizvodnje ali objekt, vključen v proizvodnjo in preskušanje. \| (b) \| Vključijo se podrobni podatki v zvezi s kontrolnimi preskusi izdelka, ki se lahko izvajajo med katero koli vmesno fazo postopka proizvodnje, da se zagotovi konsistentnost postopka proizvodnje. \| Ti preskusi so pomembni za preverjanje skladnosti zdravila s sestavo, če vlagatelj izjemoma predlaga analizno metodo za preskušanje končnega izdelka, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi ob upoštevanju enakih zahtev kot za zdravilne učinkovine). \| Enako velja, kadar je kontrola kakovosti končnega izdelka odvisna od preskusov medfazne kontrole, zlasti, če je zdravilo bistveno opredeljeno s postopkom priprave. \| (c) \| Predložijo se opis, dokumentacija in rezultati validacijskih študij za pomembne faze ali pomembna določanja vsebnosti, ki se uporabljajo v postopku proizvodnje. \| 3.2.2.4 Kontrola pomožnih snovi \| (a) \| Navede se seznam vseh snovi, potrebnih za proizvodnjo pomožne(-ih) snovi in opredeli, kje v postopku se posamezne snovi uporabljajo. Predložijo se podatki o kakovosti in kontroli teh snovi. Navedejo se podatki, ki dokazujejo, da snovi izpolnjujejo standarde, ustrezne za predvideno uporabo. \| Barvila morajo v vseh primerih izpolnjevati zahteve direktiv 78/25/EGS in/ali 94/36/ES. Barvilo mora izpolnjevati tudi merila čistosti, kakor so določena v Direktivi 95/45/ES in njenih dopolnilih. \| (b) \| Podrobno se navedejo specifikacije in utemeljitev za vsako pomožno snov. Opišejo se analizni postopki in ustrezno validirajo. \| (c) \| Posebna pozornost se posveča pomožnim snovem človeškega ali živalskega izvora. \| Kar zadeva posebne ukrepe za preprečevanje prenosa živalskih spongiformnih encefalopatij, mora vlagatelj tudi za pomožne snovi dokazati, da je zdravilo proizvedeno skladno z Navodili o zmanjšanju tveganja prenosa živalske spongiformne encefalopatije z zdravilom na minimum, ter z vsemi dopolnili navodil, ki jih je Komisija izdala v Uradnem listu Evropske unije. \| Skladnost z navedenimi navodili je mogoče dokazati po možnosti s predložitvijo certifikata o ustreznosti pripadajoči monografiji o prenosljivih spongiformnih encefalopatijah Evropske farmakopeje ali z vročitvijo znanstvenih podatkov, ki utemeljujejo skladnost. \| (d) \| Nove pomožne snovi \| V skladu z obliko zdravilne učinkovine, opisane predhodno, se za pomožno(-e) snov(-i), ki se v zdravilu uporablja(-jo) prvič ali je pot uporabe nova, predložijo vse podrobnosti postopka proizvodnje, opis lastnosti in kontrol, s sklicevanjem na spremljajoče podatke o klinični ali neklinični varnosti. \| Predloži se dokument, ki vključuje podrobne kemijske, farmacevtske in biološke podatke. Ti podatki se strukturirajo po enakem vrstnem redu kakor poglavje, ki obravnava zdravilno(-e) učinkovino(-e) modula 3. \| Podatki o novi(-ih) pomožni(-ih) snovi(-eh) se lahko predložijo kot samostojen dokument ob upoštevanju strukture, opisane v predhodnem odstavku. Kadar vlagatelj ni proizvajalec nove pomožne snovi, se mu navedeni samostojni dokument da na voljo za predložitev pristojnemu organu. \| Dodatni podatki o študijah toksičnosti z novo pomožno snovjo se navedejo v modulu 4 dokuemntacije. \| Klinične študije se predložijo v modulu 5. \| 3.2.2.5 Kontrola končnega izdelka \| Pri kontroli končnega izdelka, je serija zdravila entiteta, ki obsega vse enote farmacevtske oblike, ki so proizvedene iz iste začetne količine snovi in so bile podvržene istim vrstam delovnih postopkov proizvodnje in/ali sterilizacije, ali v primeru neprekinjenega postopka proizvodnje, vse enote, proizvedene v določenem časovnem obdobju. \| V času proizvodnje največja dopustna meja odstopanja vsebnosti zdravilne učinkovine v končnem izdelku ne presega ± 5 %, razen če za to ni ustrezne utemeljitve. \| Predložijo se podrobni podatki o specifikacijah (za sproščanje in do izteka roka uporabnosti), utemeljitev za njihovo izbiro, analizne metode in njihova validacija. \| 3.2.2.6 Referenčni standardi ali snovi \| Referenčni pripravki in standardi, ki se uporabljajo za preskušanje končnih izdelkov, se opredelijo in podrobno opišejo, če niso že prej navedeni v oddelku v zvezi z zdravilno učinkovino. \| 3.2.2.7 Vsebnik in zapiranje končnega izdelka \| Predloži se opis vsebnika in sistema(-ov) zapiranja, vključno z opredelitvijo vseh snovi stične ovojnine ter njihovih specifikacij. Specifikacije vključujejo opis in identifikacijo. Kadar je to primerno, se vključijo metode (z validacijo), ki jih farmakopeja ne vsebuje. \| Za snovi nefunkcionalne zunanje ovojnine se predloži samo kratek opis. Za snovi funkcionalne zunanje ovojnine se predložijo dodatni podatki. \| 3.2.2.8 Stabilnost končnega izdelka \| (a) \| Predložijo se povzetki vrst opravljenih študij, uporabljenih protokolov in rezultatov študij. \| (b) \| V ustrezni strukturi se predložijo podrobni rezultati študij stabilnosti, vključno s podatki o analiznih postopkih, uporabljenih za pridobitev podatkov, ter o validaciji teh postopkov; pri cepivih se predložijo, kadar je to primerno, podatki o kumulativni stabilnosti; \| (c) \| Predložita se protokol o stabilnosti, potem ko je zdravilo že dobilo dovoljenje za promet, ter zaveza o spremljanju stabilnosti.	3.2.2. \| Finished medicinal product \| 3.2.2.1. Description and composition of the finished medicinal product \| A description of the finished medicinal product and its composition shall be provided. The information shall include the description of the pharmaceutical form and composition with all the constituents of the finished medicinal product, their amount on a per-unit basis, the function of the constituents of: \| — \| the active substance(s), \| — \| the constituent(s) of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances, etc., \| — \| the constituents, intended to be ingested or otherwise administered to the patient, of the outer covering of the medicinal products (hard capsules, soft capsules, rectal capsules, coated tablets, films-coated tablets, etc.), \| — \| these particulars shall be supplemented by any relevant data concerning the type of container and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be delivered with the medicinal product. \| The ‘usual terminology’, to be used in describing the constituents of medicinal products, shall mean, notwithstanding the application of the other provisions in Article 8 (3) (c): \| — \| in respect of substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title at the head of the monograph in question, with reference to the pharmacopoeia concerned, \| — \| in respect of other substances, the international non-proprietary name (INN) recommended by the World Health Organisation, or, failing this, the exact scientific designation; substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details, \| — \| in respect of colouring matter, designation by the ‘E’ code assigned to them in Council Directive 78/25/EEC of 12 December 1977 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in medicinal products ( 25 ) and/or European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs ( 26 ). \| In order to give the ‘quantitative composition’ of the active substance(s) of the finished medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance. \| Active substances present in the form of compounds or derivatives shall be designated quantitatively by their total mass, and if necessary or relevant, by the mass of active entity or entities of the molecule. \| For medicinal products containing an active substance, which is the subject of an application for marketing authorisation in any Member State for the first time, the quantitative statement of an active substance, which is a salt or hydrate shall be systematically expressed in terms of the mass of the active entity or entities in the molecule. All subsequently authorised medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance. \| Units of biological activity shall be used for substances, which cannot be defined molecularly. Where an International Unit of biological activity has been defined by the World Health Organisation, this shall be used. Where no International Unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances by using where applicable the European Pharmacopoeia Units. \| 3.2.2.2. Pharmaceutical development \| This chapter shall be devoted to information on the development studies conducted to establish that the dosage form, the formulation, manufacturing process, container closure system, microbiological attributes and usage instructions are appropriate for the intended use specified in the marketing authorisation application dossier. \| The studies described in this chapter are distinct from routine control tests conducted according to specifications. Critical parameters of the formulation and process attributes that can influence batch reproducibility, medicinal product performance and medicinal product quality shall be identified and described. Additional supportive data, where appropriate, shall be referenced to the relevant chapters of Module 4 (Non Clinical Study Reports) and Module 5 (Clinical Study Reports) of the marketing authorisation application dossier. \| a) \| The compatibility of the active substance with excipients as well as key physicochemical characteristics of the active substance that can influence the performance of the finished product or the compatibility of different active substances with each other in the case of combination products, shall be documented. \| b) \| The choice of excipients, in particular relative to their respective functions and concentration shall be documented. \| c) \| A description of the development of the finished product shall be provided, taking into consideration the proposed route of administration and usage. \| d) \| Any overages in the formulation(s) shall be warranted. \| e) \| As far as the physiochemical and biological properties are concerned, any parameter relevant to the performance of finished product shall be addressed and documented. \| f) \| The selection and optimisation of the manufacturing process as well as differences between the manufacturing process(es) used to produce pivotal clinical batches and the process used for manufacturing the proposed finished medicinal product shall be provided. \| g) \| The suitability of the container and closure system used for the storage, shipping and use of the finished product shall be documented. A possible interaction between medicinal product and container may need to be considered. \| h) \| The microbiological attributes of the dosage form in relation with non-sterile and sterile products shall be in accordance with and documented as prescribed in the European Pharmacopoeia. \| i) \| In order to provide appropriate and supportive information for the labelling the compatibility of the finished product with reconstitution diluent(s) or dosage devices shall be documented. \| 3.2.2.3. Manufacturing process of the finished medicinal product \| a) \| The description of the manufacturing method accompanying the application for Marketing Authorisation pursuant to Article 8 (3) (d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed. \| For this purpose it shall include at least: \| — \| mention of the various stages of manufacture including process controls and corresponding acceptance criteria, so that an assessment can be made of whether the processes employed in producing the pharmaceutical form might have produced an adverse change in the constituents, \| — \| in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product, \| — \| experimental studies validating the manufacturing process, where a non-standard method of manufacture is used or where it is critical for the product, \| — \| for sterile medicinal products, details of the sterilisation processes and/or aseptic procedures used, \| — \| a detailed batch formula. \| The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing shall be provided. \| b) \| Particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the production process shall be included. \| These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient constituents subject to the same requirements as the active substances). \| The same applies where the quality control of the finished product depends on in-process control tests, particularly if the medicinal product is essentially defined by its method of preparation. \| c) \| Description, documentation, and results of the validation studies for critical steps or critical assays used in the manufacturing process shall be provided. \| 3.2.2.4. Control of excipients \| a) \| All the materials needed in order to manufacture the excipient(s) shall be listed identifying where each material is used in the process. Information on the quality and control of these materials shall be provided. Information demonstrating that materials meet standards appropriate for their intended use shall be provided. \| Colouring matter shall, in all cases, satisfy the requirements of Directives 78/25/EEC and/or 94/36/EC. In addition, colouring matter shall meet purity criteria as laid down in Directive 95/45/EC, as amended. \| b) \| For each excipient, the specifications and their justifications shall be detailed. The analytical procedures shall be described and duly validated. \| c) \| Specific attention shall be paid to excipients of human or animal origin. \| Regarding the specific measures for the prevention of the Transmission of animal Spongiform Encephalopathies, the applicant must demonstrate also for excipients that the medicinal product is manufactured in accordance with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union. \| Demonstration of compliance with the aforementioned Note for Guidance can be done by submitting either preferably a certificate of suitability to the relevant monograph on Transmissible Spongiform Encephalopathies of the European Pharmacopoeia, or by the supply of scientific data to substantiate this compliance. \| d) \| Novel excipients: \| For excipient(s) used for the first time in a medicinal product or by a new route of administration, full details of manufacture, characterisation, and controls, with cross references to supporting safety data, both non-clinical and clinical, shall be provided according to the active substance format previously described. \| A document containing the detailed chemical, pharmaceutical and biological information shall be presented. This information shall be formatted in the same order as the chapter devoted to Active Substance(s) of Module 3. \| Information on novel excipient(s) may be presented as a stand-alone document following the format described in the former paragraphs. Where the applicant differs from the novel excipient manufacturer the said stand-alone document shall be made available to the applicant for submission to the competent authority. \| Additional information on toxicity studies with the novel excipient shall be provided in Module 4 of the dossier. \| Clinical studies shall be provided in Module 5. \| 3.2.2.5. Control of the finished medicinal product \| For the control of the finished medicinal product, a batch of a medicinal product is an entity which comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilisation operations or, in the case of a continuous production process, all the units manufactured in a given period of time. \| Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture. \| Detailed information on the specifications, (release and shelf life) justification for their choice, methods of analysis and their validation shall be provided. \| 3.2.2.6. Reference standards or materials \| Reference preparations and standards used for testing of the finished medicinal product shall be identified and described in detail, if not previously provided in the section related to the active substance. \| 3.2.2.7. Container and closure of the finished medicinal product \| A description of the container and the closure system(s) including the identity of each immediate packaging material and their specifications shall be provided. The specifications shall include description and identification. Non-pharmacopoeial methods (with validation) shall be included where appropriate. \| For non-functional outer packaging materials only a brief description shall be provided. For functional outer packaging materials additional information shall be provided. \| 3.2.2.8. Stability of the finished medicinal product \| a) \| The types of studies conducted, protocols used, and the results of the studies shall be summarised; \| b) \| Detailed results of the stability studies, including information on the analytical procedures used to generate the data and validation of these procedures shall be presented in an appropriate format; in case of vaccines, information on cumulative stability shall be provided where appropriate; \| c) \| The post authorisation stability protocol and stability commitment shall be provided.
4. MODUL 4: NEKLINIČNA POROČILA	4. MODULE 4: NON-CLINICAL REPORTS
4.1 Struktura in oblika	4.1. Format and Presentation
Splošna struktura modula 4 je, kakor sledi:	The general outline of Module 4 is as follows:
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Pregled vsebine	Table of contents
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Poročila o študijah	Study reports
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Farmakologija	Pharmacology
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Primarna farmakodinamika	Primary Pharmaco-dynamics
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Sekundarna farmakodinamika	Secondary Pharmaco-dynamics
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Farmakologija varnosti	Safety Pharmacology
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Farmakodinamične interakcije	Pharmaco-dynamic Interactions
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Farmakokinetika	Pharmaco-kinetics
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Analizne metode in validacijska poročila	Analytical Methods and Validation Reports
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Absorpcija	Absorption
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Porazdelitev	Distribution
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Presnova	Metabolism
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Izločanje	Excretion
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Farmakokinetične interakcije (neklinične)	Pharmaco-kinetic Interactions (non-clinical)
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Druge farmakokinetične študije	Other Pharmaco-kinetic Studies
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Toksikologija	Toxicology
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Toksičnost pri enkratnem odmerku	Single-Dose Toxicity
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Toksičnost pri ponavljajočih odmerkih	Repeat-Dose Toxicity
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Genotoksičnost	Genotoxicity
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In vitro	In vitro
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In vivo (vključno s spremljajočimi toksikološko-kinetičnimi ovrednotenji)	In vivo (including supportive toxico-kinetics evaluations)
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Rakotvornost	Carcinogenicity
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Dolgotrajne študije	Long-term studies
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Kratkotrajne in srednjetrajne študije	Short- or medium-term studies
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Druge študije	Other studies
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Toksičnost za razmnoževanje in razvoj	Reproductive and Developmental Toxicity
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Rodnost in zgodnji razvoj zarodka	Fertility and early embryonic development
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Razvoj zarodka/plodu	Embryo-fetal development
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Razvoj pred rojstvom in po njem	Prenatal and postnatal development
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Študije, pri katerih se mladičem (nedoraslim živalim) dajejo odmerki in/ali se nadalje ovrednotijo	Studies in which the offspring (juvenile animals) are dosed and/or further evaluated
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Lokalna toleranca	Local Tolerance
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Druge študije toksičnosti	Other Toxicity Studies
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Antigenost	Antigenicity
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Imunotoksičnost	Immuno-toxicity
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Študije mehanizmov	Mechanistic studies
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Odvisnost	Dependence
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Presnovki	Metabolites
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Nečistote	Impurities
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Drugo	Other
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Navedba literature	Literature references
4.2 Vsebina: temeljna načela in zahteve	4.2. Content: basic principles and requirements
Posebna pozornost se posveti naslednjim izbranim elementom.	Special attention shall be paid to the following selected elements.
(1)	(1)
Farmakološki in toksikološki preskusi morajo pokazati:	The pharmacological and toxicological tests must show:
(a)	a)
morebitno toksičnost zdravila in vse nevarne ali neželene toksične učinke, ki lahko nastopijo v predlaganih pogojih uporabe pri ljudeh; te je treba ovrednotiti v zvezi z zadevnimi patološkimi stanji;	the potential toxicity of the product and any dangerous or undesirable toxic effects that may occur under the proposed conditions of use in human beings; these should be evaluated in relation to the pathological condition concerned;
(b)	b)
farmakološke lastnosti zdravila v kakovostni in količinski povezavi do predlagane uporabe pri ljudeh. Vsi rezultati morajo biti zanesljivi ter splošno uporabni. Kadarkoli je primerno, se pri načrtovanju eksperimentalnih metod ter pri ovrednotenju rezultatov uporabijo matematične in statistične metode.	the pharmacological properties of the product, in both qualitative and quantitative relationship to the proposed use in human beings. All results must be reliable and of general applicability. Whenever appropriate, mathematical and statistical procedures shall be used in designing the experimental methods and in evaluating the results.
Potrebno pa je tudi, da so kliniki obveščeni o terapevtskem in toksikološkem potencialu zdravila.	Additionally, it is necessary for clinicians to be given information about the therapeutic and toxicological potential of the product.
(2)	(2)
Pri bioloških zdravilih, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, bo zahteve tega modula morda treba prilagoditi posameznim zdravilom; zato vlagatelj utemelji izvedeni program preskušanja.	For biological medicinal products such as immunological medicinal products and medicinal products derived from human blood or plasma, the requirements of this Module may have to be adapted for individual products; therefore the testing program carried out shall be justified by the applicant.
Pri pripravi programa preskušanja se upošteva naslednje:	In establishing the testing program, the following shall be taken into consideration:
vsi preskusi, ki zahtevajo večkratno dajanje zdravila, se načrtujejo tako, da upoštevajo možno indukcijo protiteles in z njimi povzročeno interferenco;	all tests requiring repeated administration of the product shall be designed to take account of the possible induction of, and interference by, antibodies;
upoštevajo se raziskave vplivov na sposobnost razmnoževanja, toksičnosti za zarodek/plod in obporodne toksičnosti, mutagenega potenciala in rakotvornega potenciala. Kadar se potencial pripisuje sestavinam, ki niso zdravilne učinkovine, se študija lahko nadomesti z validacijo njihove odstranitve.	examination of reproductive function, of embryo/foetal and peri-natal toxicity, of mutagenic potential and of carcinogenic potential shall be considered. Where constituents other than the active substance(s) are incriminated, validation of their removal may replace the study.
(3)	(3)
Razišče se toksikologija in farmakokinetika pomožne snovi, ki se prvikrat uporablja na farmacevtskem področju.	The toxicology and pharmaco-kinetics of an excipient used for the first time in the pharmaceutical field shall be investigated.
(4)	(4)
Kadar obstaja možnost značilne razgradnje med shranjevanjem zdravila, je treba preučiti toksikologijo razgradnih produktov.	Where there is a possibility of significant degradation during storage of the medicinal product, the toxicology of degradation products must be considered.
4.2.1 Farmakologija	4.2.1. Pharmacology
Farmakološka študija sledi dvema ločenima smerema pristopa.	Pharmacology study shall follow two distinct lines of approach.
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V prvi se ustrezno raziščejo in opišejo učinki v zvezi s predlagano terapevtsko uporabo. Kadar je mogoče, se uporabljajo priznane in validirane določitve vsebnosti, in vivo ter in vitro. Nove poskusne metode je treba opisati tako podrobno, da se omogoči njihova ponovljivost. Rezultati se izrazijo količinsko s pomočjo, na primer, krivulj odvisnosti učinka od odmerka, krivulj odvisnosti učinka od časa, itd. Kadarkoli je mogoče, se naredi primerjava s podatki o snovi ali snoveh s podobnim terapevtskim delovanjem.	Firstly, the actions relating to the proposed therapeutic use shall be adequately investigated and described. Where possible, recognised and validated assays, both in vivo and in vitro, shall be used. Novel experimental techniques must be described in such detail as to allow them to be reproduced. The results shall be expressed in quantitative terms using, for example, dose-effect curves, time-effect curves, etc. Wherever possible, comparisons shall be made with data relating to a substance or substances with a similar therapeutic action.
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V drugi, vlagatelj opravi raziskavo možnih neželenih farmakodinamičnih učinkov snovi na fiziološke funkcije. Te raziskave se izvedejo ob izpostavljenosti v predvidenem terapevtskem območju in nad njim. Eksperimentalne metode, razen če gre za standardne postopke, je treba opisati tako podrobno, da se omogoči njihova ponovljivost, raziskovalec pa mora dokazati njihovo veljavnost. Opravi se raziskava vsake sumljive spremembe odzivov, ki so posledica ponavljajočega dajanja snovi.	Secondly, the applicant shall investigate the potential undesirable pharmaco-dynamic effects of the substance on physiological functions. These investigations shall be performed at exposures in the anticipated therapeutic range and above. The experimental techniques, unless they are standard procedures, must be described in such detail as to allow them to be reproduced, and the investigator must establish their validity. Any suspected modification of responses resulting from repeated administration of the substance shall be investigated.
Za farmakodinamično interakcijo zdravila se preskuse na kombinacijah zdravilnih učinkovin lahko spodbuja s farmakološkimi premisami ali z navedbami terapevtskega učinka. V prvem primeru farmakodinamična študija pokaže tiste interakcije, ki bi lahko pokazale pomembnost kombinacije pri terapevtski uporabi. V drugem primeru, kadar se znanstvena utemeljitev za kombinacijo ugotavlja s pomočjo terapevtskih poskusov, raziskava določi vsaj, ali se pričakovani učinki kombinacije lahko pokažejo na živalih, in opravi se vsaj raziskava pomembnosti vseh morebitnih dodatnih učinkov.	For the pharmaco-dynamic medicinal product interaction, tests on combinations of active substances may be prompted either by pharmacological premises or by indications of therapeutic effect. In the first case, the pharmaco-dynamic study shall demonstrate those interactions, which might make the combination of value in therapeutic use. In the second case, where scientific justification for the combination is sought through therapeutic experimentation, the investigation shall determine whether the effects expected from the combination can be demonstrated in animals, and the importance of any collateral effects shall at least be investigated.
4.2.2 Farmakokinetika	4.2.2. Pharmaco-kinetics
Farmakokinetika vključuje študijo obnašanja zdravilne učinkovine in njenih presnovkov v organizmu in vključuje študijo absorpcije, porazdelitve, presnove (biotransformacije) in izločanja teh snovi.	Pharmaco-kinetics means the study of the fate of the active substance, and its metabolites, within the organism, and covers the study of the absorption, distribution, metabolism (bio-transformation) and excretion of these substances.
Študijo navedenih različnih faz je mogoče izvajati predvsem s pomočjo fizikalnih, kemijskih ali morebiti bioloških metod in z opazovanjem dejanske farmakodinamične aktivnosti snovi same.	The study of these different phases may be carried mainly by means of physical, chemical or possibly by biological methods, and by observation of the actual pharmaco-dynamic activity of the substance itself.
Podatki o porazdelitvi in izločanju so potrebni v vseh primerih, kjer so taki podatki nujno potrebni za določanje odmerjanja pri ljudeh, ter pri kemoterapevtikih (antibiotikih, itd.) ter snoveh, katerih uporaba je odvisna od njihovih nefarmakodinamičnih učinkov (npr. številne snovi za diagnostične namene, itd.).	Information on distribution and elimination shall be necessary in all cases where such data are indispensable to determine the dosage for humans, and in respect of chemo-therapeutic substances (antibiotics, etc.) and substances whose use depends on their non-pharmaco-dynamic effects (e.g. numerous diagnostic agents, etc.).
Študije in vitro se lahko izvajajo tudi tako, da se izkoristi uporaba človeške snovi za primerjavo z živalsko snovjo (t.j. vezava na proteine, presnova, interakcije med zdravili).	In vitro studies also can be carried out with the advantage of using human material for comparison with animal material (i.e. protein binding, metabolism, drug-drug interaction).
Potrebna je farmakokinetična raziskava vseh farmakološko aktivnih učinkovin. Pri novih kombinacijah znanih snovi, raziskanih v skladu z določbami te direktive, farmakokinetične študije niso nujno potrebne, če se njihovo opustitev utemelji s preskusi toksičnosti ter terapevtskimi poskusi.	Pharmaco-kinetic investigation of all pharmacologically active substances is necessary. In the case of new combinations of known substances, which have been investigated in accordance with the provisions of this Directive, pharmaco-kinetic studies may not be required, if the toxicity tests and therapeutic experimentation justify their omission.
Oblikuje se farmakokinetični program, ki omogoča primerjavo med živaljo in človekom ter ekstrapolacijo.	The pharmaco-kinetic program shall be design to allow comparison and extrapolation between animal and human.
4.2.3 Toksikologija	4.2.3. Toxicology
(a)	a)
Toksičnost pri enkratnem odmerku	Single-dose toxicity
Toksičnost pri enkratnem odmerku je kakovostna in količinska študija toksičnih reakcij, ki so lahko posledica enkratnega dajanja zdravilne učinkovine ali učinkovin, ki jih vsebuje zdravilo, v deležih in v fizikalno-kemijskem stanju, v katerem so prisotne v obstoječem izdelku.	A single-dose toxicity test shall mean a qualitative and quantitative study of the toxic reactions, which may result from a single administration of the active substance or substances contained in the medicinal product, in the proportions and physico-chemical state in which they are present in the actual product.
Toksičnost pri enkratnem odmerku je treba opraviti v skladu z ustreznimi smernicami, ki jih je objavila Agencija.	The single-dose toxicity test must be carried out in accordance with the relevant guidelines published by the Agency.
(b)	b)
Toksičnost pri ponavljajočih odmerkih	Repeat-dose toxicity
Namen preskusov toksičnosti pri ponavljajočih odmerkih je odkrivanje vsakih fizioloških in/ali anatomsko patoloških sprememb, ki jih povzroča ponavljajoče dajanje zdravilne učinkovine ali kombinacije zdravilnih učinkovin, ki jih preučujemo, ter določitev povezave med spremembami in odmerjanjem.	Repeated dose toxicity tests are intended to reveal any physiological and/or anatomo-pathological changes induced by repeated administration of the active substance or combination of active substances under examination, and to determine how these changes are related to dosage.
Na splošno je zaželeno, da se izvedeta dva preskusa: en kratkotrajen preskus, ki traja dva do štiri tedne, in drugi, ki je dolgotrajen. Trajanje dolgotrajnega preskusa je odvisno od pogojev klinične uporabe. Namen tega preskusa je opisati možne neželene učinke, na katere je treba biti pozoren pri v kliničnih študijah. Trajanje je opredeljeno v ustreznih smernicah, ki jih je objavila Agencija.	Generally, it is desirable that two tests be performed: one short term, lasting two to four weeks, the other long-term. The duration of the latter shall depend on the conditions of clinical use. Its purpose is to describe potential adverse effects to which attention should be paid in clinical studies. The duration is defined in the relevant guidelines published by the Agency.
(c)	c)
Genotoksičnost	Geno-toxicity
Namen študije mutagenega in klastogenega potenciala je pokazati spremembe, ki jih snov lahko povzroči v genskem materialu posameznikov ali celicah. Mutagene snovi lahko predstavljajo tveganje za zdravje, ker izpostavljenost mutagenu nosi tveganje sprožitve mutacije zarodne linije, z možnostjo podedovanja nepravilnosti ter tveganje somatskih mutacij, vključno z mutacijami, katerih posledica je rak. Te študije so obvezne za vsako novo snov.	The purposes of the study of mutagenic and clastogenic potential is to reveal the changes which a substance may cause in the genetic material of individuals or cells. Mutagenic substances may present a hazard to health since exposure to a mutagen carries the risk of inducing germ-line mutation, with the possibility of inherited disorders, and the risk of somatic mutations including those leading to cancer. These studies are obligatory for any new substance.
(d)	d)
Rakotvornost	Carcino-genicity
Preskusi za odkrivanje rakotvornih učinkov se običajno zahtevajo:	Tests to reveal carcinogenic effects shall normally be required:
1.	1.
Te študije se izvedejo za vsako zdravilo, katerega klinična uporaba je predvidena za podaljšano obdobje bolnikovega življenja in ga bo prejemal nenehno ali v ponavljajočih odmerkih v presledkih.	These studies shall be performed for any medicinal product whose expected clinical use is for a prolonged period of a patient's life, either continuously or repeatedly in an intermittent manner.
2.	2.
Te študije se priporočajo za nekatera zdravila, če obstaja skrb zaradi njihovega rakotvornega potenciala, npr. zaradi zdravila iste skupine ali podobne strukture, ali zaradi dokazov v študijah toksičnosti pri ponavljajočih odmerkih.	These studies are recommended for some medicinal products if there is concern about their carcinogenic potential, e.g. from product of the same class or similar structure, or from evidence in repeated dose toxicity studies.
3.	3.
Študije nedvoumno genotoksičnih spojin niso potrebne, ker se za take spojine predpostavlja, da so kancerogene za vse vrste in pomenijo tveganje za ljudi. Če je tako zdravilo predvideno za kronično dajanje ljudem, bo za odkritje zgodnjih tumorogenih učinkov morda potrebna dolgotrajna študija.	Studies with unequivocally geno-toxic compounds are not needed, as they are presumed to be trans-species carcinogens, implying a hazard to humans. If such a medicinal product is intended to be administered chronically to humans a chronic study may be necessary to detect early tumorigenic effects.
(e)	e)
Toksičnost za razmnoževanje in razvoj	Reproductive and developmental toxicity
Z ustreznimi preskusi se opravi raziskava možne prizadetosti sposobnosti razmnoževanja samca ali samice kot tudi škodljivih učinkov na potomce.	Investigation of possible impairment of male or female reproductive function as well as harmful effects on progeny shall be performed by appropriate tests.
Ti preskusi vključujejo študije učinkov na sposobnost razmnoževanja odraslega samca ali samice, študije toksičnih in teratogenih učinkov na vseh stopnjah razvoja od spočetja do spolne zrelosti ter latentnih učinkov, ko je preiskovano zdravilo prejela samica v času brejosti.	These tests comprise studies of effect on adult male or female reproductive function, studies of the toxic and teratogenic effects at all stages of development from conception to sexual maturity as well as latent effects, when the medicinal product under investigation has been administered to the female during pregnancy.
Opustitev teh preskusov je treba ustrezno utemeljiti.	Omission of these tests must be adequately justified.
Odvisno od navedene uporabe zdravila, se lahko določijo dopolnilne študije, ki obravnavajo razvoj, ko zdravilo prejema mladič.	Depending on the indicated use of the medicinal product, additional studies addressing development when administering the medicinal product of the offspring may be warranted.
Študije toksičnosti za zarodek/plod je običajno treba izvajati na dveh vrstah sesalcev, od katerih ena ni glodalec. Obporodne in postnatalne študije se izvajajo na najmanj eni živalski vrsti. Kadar je presnova zdravila pri določeni vrsti podobna presnovi pri človeku, je zaželeno, da se ta živalska vrsta vključi. Prav tako je zaželeno, da je ena od živalskih vrst enaka kot pri preskusih toksičnosti pri ponavljajočih odmerkih.	Embryo/foetal toxicity studies shall normally be conducted on two mammalian species, one of which shall be other than a rodent. Peri- and postnatal studies shall be conducted in at least one species. If the metabolism of a medicinal product in particular species is known to be similar to that in man, it is desirable to include this species. It is also desirable that one of the species is the same as in the repeated dose toxicity studies.
Pri določanju načrta študije se upošteva stanje znanstvenih dognanj v času predložitve vloge.	The state of scientific knowledge at the time when the application is lodged shall be taken into account when determining the study design.
(f)	f)
Lokalna toleranca	Local tolerance
Namen študij lokalne tolerance zdravila je preveriti toleranco zdravil (tako zdravilnih učinkovin kot pomožnih snovi) na delih telesa, ki lahko pridejo v stik z zdravilom kot posledica dajanja zdravila v klinični uporabi. Strategija preskusov je taka, da je mogoče razlikovati mehanske učinke dajanja zdravila ali samo fizikalno kemijsko delovanje zdravila od toksikološkega ali farmakodinamičnega delovanja.	The purpose of local tolerance studies is to ascertain whether medicinal products (both active substances and excipients) are tolerated at sites in the body, which may come into contact with the medicinal product as a result of its administration in clinical use. The testing strategy shall be such that any mechanical effects of administration or purely physico-chemical actions of the product can be distinguished from toxicological or pharmaco-dynamic ones.
Preskušanje lokalne tolerance se izvede s pripravkom, razvitim za ljudi, s pomočjo vehikla in/ali pomožnih snovi pri obravnavanju kontrolne(-ih) skupine/skupin. Kadar je to potrebno, se vključijo pozitivne kontrole/referenčne snovi.	Local tolerance testing shall be conducted with the preparation being developed for human use, using the vehicle and/or excipients in treating the control group(s). Positive controls/reference substances shall be included where necessary.
Načrt preskusov lokalne tolerance (izbira vrste, trajanje, pogostost in pot dajanja zdravila, odmerki) bo odvisna od problema, ki ga je treba raziskati in predlaganih pogojev dajanja v klinični uporabi. Prikaže naj se reverzibilnost lokalnih lezij, kadar je to ustrezno.	The design of local tolerance tests (choice of species, duration, frequency and route of administration, doses) will depend upon the problem to be investigated and the proposed conditions of administration in clinical use. Reversibility of local lesions shall be performed where relevant.
Študije na živalih se lahko nadomestijo z validiranimi preskusi in vitro, pod pogojem, da so rezultati preskusov primerljive kakovosti in uporabnosti za namen ovrednotenja varnosti.	Studies in animals can be substituted by validated in vitro tests provided that the test results are of comparable quality and usefulness for the purpose of safety evaluation.
Pri kemikalijah, ki se nanašajo na kožo (npr. dermalne, rektalne, vaginalne), se potencial preobčutljivosti ovrednoti na vsaj enem preskusnem sistemu, ki je trenutno na voljo (preskus na morskem prašičku ali lokalna analiza limfnih vodov).	For chemicals applied to the skin (e.g. dermal, rectal, vaginal) the sensitising potential shall be evaluated in at least one of the test systems currently available (the guinea pig assay or the local lymph node assay).
5. MODUL 5: POROČILA O KLINIČNIH ŠTUDIJAH	5. MODULE 5: CLINICAL STUDY REPORTS
5.1 Struktura in oblika	5.1. Format and Presentation
Splošna struktura modula 5 je, kakor sledi:	The general outline of Module 5 is as follows:
—	—
Pregled vsebine poročil o kliničnih študijah	Table of contents for clinical study reports
—	—
Navedba vseh kliničnih študij v obliki preglednice	Tabular listing of all clinical studies
—	—
Poročila o kliničnih študijah	Clinical study reports
—	—
Poročila o biofarmacevtskih študijah	Reports of Bio-pharmaceutical Studies
—	—
Poročila o študiji biološke uporabnosti	Bio-availability Study Reports
—	—
Poročila o primerjalnih študijah biološke uporabnosti in bioekvivalence	Comparative Bio-availability and Bio-equivalence Study Reports
—	—
Poročilo o študiji korelacije in vitro - in vivo	In vitro — In vivo Correlation Study Report
—	—
Poročila o bioanaliznih in analiznih metodah	Reports of Bio-analytical and Analytical Methods
—	—
Poročila o študijah, ki se nanašajo na farmakokinetiko ob uporabi človeških bioloških materialov	Reports of Studies Pertinent to Pharmaco-kinetics Using Human Bio-materials
—	—
Poročila o študijah vezave na proteine v plazmi	Plasma Protein Binding Study Reports
—	—
Poročila o študijah jetrne presnove in študije interakcij	Reports of Hepatic Metabolism and Interaction Studies
—	—
Poročila o študijah, ki uporabljajo druge človeške biološke materiale	Reports of Studies Using Other Human Bio-materials
—	—
Poročila o študijah farmakokinetike pri ljudeh	Reports of Human Pharmaco-kinetic Studies
—	—
Poročila o študijah farmakokinetike pri zdravih posameznikih in začetno prenašanje	Healthy subjects Pharmaco-kinetics and Initial Tolerability Study Reports
—	—
Poročila o študijah farmakokinetike pri bolnikih in začetno prenašanje	Patient Pharmaco-kinetics and Initial Tolerability Study Reports
—	—
Poročila o študijah farmakokinetike intrinzičnih faktorjev	Intrinsic Factor Pharmaco-kinetics Study Reports
—	—
Poročila o študijah farmakokinetike ekstrinzičnih faktorjev	Extrinsic Factor Pharmaco-kinetics Study Reports
—	—
Poročila o študijah farmakokinetike pri skupinah ljudi	Population Pharmaco-kinetics Study Reports
—	—
Poročila o študijah farmakodinamike pri ljudeh	Reports of Human Pharmaco-dynamic Studies
—	—
Poročila o študijah farmakodinamike in farmakokinetike/farmakodinamike pri zdravih posameznikih	Healthy Subject Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Study Reports
—	—
Poročila o študijah farmakodinamike in farmakokinetike/farmakodinamike pri bolnikih	Patient Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Studies Study Reports
—	—
Poročila o študijah učinkovitosti in varnosti	Reports of Efficacy and Safety Studies
—	—
Poročila o študijah kontrolnih kliničnih študij, ki se nanašajo na določeno indikacijo	Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
—	—
Poročila o študijah nekontroliranih kliničnih študij	Study Reports of Uncontrolled Clinical Studies
—	—
Poročila o analizah podatkov iz več kot ene študije, vključno z vsemi morebitnimi formalnimi celostnimi analizami, metaanalizami in premostitvenimi analizami	Reports of Analyses of Data from More than One Study including any formal integrated analyses, meta-analyses and bridging analyses
—	—
Poročila o drugih študijah	Other Study Reports
—	—
Poročila o izkušnjah po začetku trženja	Reports of Post-marketing Experience
—	—
Navedba literature	Literature references
5.2 Vsebina: temeljna načela in zahteve	5.2. Content: basic principles and requirements
Posebna pozornost se posveti naslednjim izbranim elementom.	Special attention shall be paid to the following selected elements.
(a)	a)
Podrobni klinični podatki, ki jih je treba predložiti na podlagi členov 8(3)(i) in 10(1), morajo omogočati oblikovanje dovolj trdnega in znanstveno utemeljenega mnenja glede vprašanj, ali zdravilo izpolnjuje merila, ki vplivajo na pridobitev dovoljenja za promet z zdravilom. Zato je temeljna zahteva, da se predložijo rezultati vseh kliničnih preskušanj, ugodnih ali neugodnih.	The clinical particulars to be provided pursuant to Articles 8 (3) (i) and 10 (1) must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorisation. Consequently, an essential requirement is that the results of all clinical trials should be communicated, both favourable and unfavourable.
(b)	b)
Pred kliničnimi preskušanji je vedno treba opraviti ustrezne farmakološke in toksikološke preskuse, ki se izvedejo na živalih v skladu z zahtevami modula 4 te priloge. Raziskovalec se mora seznaniti z zaključki farmakoloških in toksikoloških študij in vlagatelj mu mora predložiti vsaj brošuro za raziskovalca, ki je sestavljena iz vseh pomembnih informacij, ki so znane pred začetkom kliničnega preskušanja, vključno s kemijskimi, farmacevtskimi in biološkimi podatki, toksikološkimi, farmakokinetičnimi in farmakodinamičnimi podatki pri živalih ter rezultati prejšnjih kliničnih preskušanj, z ustreznimi podatki, ki utemeljujejo vrsto, obseg in trajanje predlaganega preskušanja; na zahtevo se predložijo popolna farmakološka in toksikološka poročila. Pri snoveh človeškega ali živalskega izvora se uporabijo vsa razpoložljiva sredstva, da se pred začetkom preskušanja zagotovi varnost pred prenosom povzročiteljev infekcij.	Clinical trials must always be preceded by adequate pharmacological and toxicological tests, carried out on animals in accordance with the requirements of Module 4 of this Annex. The investigator must acquaint himself with the conclusions drawn from the pharmacological and toxicological studies and hence the applicant must provide him at least with the investigator's brochure, consisting of all the relevant information known prior to the onset of a clinical trial including chemical, pharmaceutical and biological data, toxicological, pharmaco-kinetic and pharmaco-dynamic data in animals and the results of earlier clinical trials, with adequate data to justify the nature, scale and duration of the proposed trial; the complete pharmacological and toxicological reports shall be provided on request. For materials of human or animal origin, all available means shall be employed to ensure safety from transmission of infectious agents prior to the commencement of the trial.
(c)	c)
Imetniki dovoljenja za promet z zdravilom morajo poskrbeti, da lastniki podatkov hranijo bistvene dokumente kliničnega preskušanja (vključno z obrazci za poročanje o primerih), razen zdravstvene dokumentacije udeleženca v preskušanju:	Marketing authorisation holders must arrange for essential clinical trial documents (including case report forms) other than subject's medical files, to be kept by the owners of the data:
—	—
vsaj 15 let po zaključku ali prenehanju preskušanja,	for at least 15 years after completion or discontinuation of the trial,
—	—
ali vsaj dve leti po izdaji zadnjega dovoljenja za promet z zdravilom v Evropski skupnosti ali, ko v Evropski skupnosti ni več vlog v postopku ali v preučevanju,	or for at least two years after the granting of the last marketing authorisation in the European Community and when there are no pending or contemplated marketing applications in the European Community,
—	—
ali vsaj dve leti po uradnem prenehanju kliničnega razvoja preiskovanega zdravila.	or for at least two years after formal discontinuation of clinical development of the investigational product.
Zdravstveno dokumentacijo udeležencev v preskušanju je treba hraniti v skladu z veljavno zakonodajo in v skladu z najdaljšim obdobjem, ki ga priporoča bolnišnica, zavod ali privatna praksa.	Subject's medical files should be retained in accordance with applicable legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.
Dokumente pa je mogoče hraniti dlje, če tako zahtevajo veljavne predpisane zahteve ali dogovor z naročnikom preskušanja. Odgovornost naročnika preskušanja je, da bolnišnico, zavod ali privatno prakso obvesti, kdaj navedenih dokumentov ni več potrebno hraniti.	The documents can be retained for a longer period, however, if required by the applicable regulatory requirements or by agreement with the sponsor. It is the responsibility of the sponsor to inform the hospital, institution or practice as to when these documents no longer need to be retained.
Naročnik preskušanja ali drug lastnik podatkov hrani vso ostalo dokumentacijo, ki se nanaša na preskušanje, vse dokler ima zdravilo dovoljenje za promet. Ta dokumentacija vključuje: protokol, ki vključuje utemeljitev, cilje in statistični načrt ter metodologijo preskušanja, skupaj s pogoji izvedbe in vodenja, ter podrobnosti o preiskovanem zdravilu, referenčno zdravilo in/ali uporabljeni placebo; standardne delovne postopke; vsa pisna mnenja o protokolu in postopkih; brošuro za raziskovalca; obrazce za poročanje o primerih pri posameznikih, udeleženih v preskušanju; zaključno poročilo; potrdilo(-a) o presoji(-ah), če je(so) na voljo. Zaključno poročilo hrani naročnik preskušanja ali poznejši lastnik še pet let po izteku dovoljenja za promet z zdravilom.	The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised. This documentation shall include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator's brochure; case report forms on each trial subject; final report; audit certificate(s), if available. The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorised.
Pri preskušanjih, ki jih opravlja Evropska skupnost, pa se imetnik dovoljenja za promet z zdravilom dodatno dogovori za arhiviranje dokumentacije v skladu z določbami Direktive 2001/20/ES in podrobnimi izvedbenimi smernicami.	In addition for trials conducted within the European Community, the marketing authorisation holder shall make any additional arrangements for archiving of documentation in accordance with the provisions of Directive 2001/20/EC and implementing detailed guidelines.
Vse spremembe lastništva podatkov se dokumentirajo.	Any change of ownership of the data shall be documented.
Vsi podatki in dokumenti naj bodo na voljo v primeru zahteve ustreznih organov.	All data and documents shall be made available if requested by relevant authorities.
(d)	d)
Podrobni podatki vsakega kliničnega preskušanja morajo vsebovati dovolj podrobnosti, da se omogoči objektivna presoja:	The particulars of each clinical trial must contain sufficient detail to allow an objective judgement to be made:
—	—
protokol, ki vključuje utemeljitev, cilje in statistični načrt ter metodologijo preskušanja, skupaj s pogoji izvedbe in vodenja, ter podrobnostmi o uporabljenem preiskovanem zdravilu,	the protocol, including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational medicinal product used
—	—
potrdilo(-a) o presoji(-ah), če je(so) na voljo,	audit certificate(s), if available
—	—
seznam raziskovalca(-ev), vsak raziskovalec pa navede svoje ime, naslov, zadolžitve, usposobljenost in klinične dolžnosti, izjavo o kraju preskušanja ter zbere podatke o vsakem posameznem bolniku, vključno z obrazcem za poročilo o primerih pri vsakem posamezniku, udeleženem v preskušanju,	the list of investigator(s), and each investigator shall give his name, address, appointments, qualifications and clinical duties, state where the trial was carried out and assemble the information in respect of each patient individually, including case report forms on each trial subject
—	—
zaključno poročilo, ki ga podpiše raziskovalec, pri multicentričnih preskušanjih pa ga podpišejo raziskovalci ali glavni raziskovalec koordinator.	final report signed by the investigator and for multi-centre trials, by all the investigators or the co-ordinating (principal) investigator.
(e)	e)
Podrobne podatke zgoraj navedenih kliničnih preskušanj se pošlje pristojnim organom. Po dogovoru s pristojnimi organi pa vlagatelj lahko izpusti del teh informacij. Celotna dokumentacija se na zahtevo predloži takoj.	The particulars of clinical trials referred to above shall be forwarded to the competent authorities. However, in agreement with the competent authorities, the applicant may omit part of this information. Complete documentation shall be provided forthwith upon request.
Raziskovalec v svojem zaključku o dokazih poskusa izrazi mnenje o varnosti zdravila v predpisanih pogojih uporabe, toleranci zdravila, učinkovitosti zdravila ter drugih koristnih informacijah glede na indikacije ter kontraindikacije, odmerjanje in povprečno trajanje zdravljenja, ter o vseh posebnih previdnostnih ukrepih med zdravljenjem ter kliničnih simptomih prevelikega odmerjanja. Pri poročanju o rezultatih multicentrične študije glavni raziskovalec v svojem zaključku v imenu vseh centrov poda mnenje o varnosti in učinkovitosti preiskovanega zdravila.	The investigator shall, in his conclusions on the experimental evidence, express an opinion on the safety of the product under normal conditions of use, its tolerance, its efficacy and any useful information relating to indications and contra-indications, dosage and average duration of treatment as well as any special precautions to be taken during treatment and the clinical symptoms of over dosage. In reporting the results of a multi-centre study, the principal investigator shall, in his conclusions, express an opinion on the safety and efficacy of the investigational medicinal product on behalf of all centres.
(f)	f)
Povzamejo se klinična opažanja pri posameznih preskušanjih, ki navajajo:	The clinical observations shall be summarised for each trial indicating:
(1)	1)
število in spol udeležencev obravnavanih v preskušanju;	the number and sex of subjects treated;
(2)	2)
izbor in starostno porazdelitev skupin bolnikov, udeleženih v preskušanju, ter primerjalne preskuse;	the selection and age-distribution of the groups of patients being investigated and the comparative tests;
(3)	3)
število bolnikov, predčasno umaknjenih iz preskušanj ter razloge za tak umik;	the number of patients withdrawn prematurely from the trials and the reasons for such withdrawal;
(4)	4)
kadar so se izvajala kontrolna preskušanja pod zgoraj navedenimi pogoji, se navede, če kontrolna skupina:	where controlled trials were carried out under the above conditions, whether the control group:
—	—
ni prejemala nobenega zdravljenja,	received no treatment
—	—
ni prejemala placeba,	received a placebo
—	—
je prejemala drugo zdravilo z znanim učinkom,	received another medicinal product of known effect
—	—
je prejemala zdravljenje, ki je bilo različno od zdravljenja z zdravili.	received treatment other than therapy using medicinal products
(5)	5)
pogostost opaženih neželenih učinkov;	the frequency of observed adverse reactions;
(6)	6)
podrobnosti o bolnikih, pri katerih je tveganje lahko povečano, npr. starejši, otroci, ženske med nosečnostjo ali menstruacijo, ali katerih fiziološko ali patološko stanje zahteva posebno obravnavo;	details concerning patients who may be at increased risk, e.g. elderly people, children, women during pregnancy or menstruation, or whose physiological or pathological condition requires special consideration;
(7)	7)
parametre ali merila vrednotenja učinkovitosti ter rezultate glede na te parametre;	parameters or evaluation criteria of efficacy and the results in terms of these parameters;
(8)	8)
statistično ovrednotenje rezultatov, če to zahteva načrt preskušanj, ter vpletenih spremenljivih dejavnikov.	a statistical evaluation of the results when this is called for by the design of the trials and the variable factors involved.
(g)	g)
Poleg tega raziskovalec vedno navede svoja opažanja o:	In addition, the investigator shall always indicate his observations on:
(1)	1)
vseh morebitnih znakih navajanja na zdravilo, zasvojenosti z zdravilom ter težavah odvajanja bolnikov od zdravila;	any signs of habituation, addiction or difficulty in weaning patients from the medicinal product;
(2)	2)
vseh morebitnih opaženih interakcijah z drugimi zdravili, ki jih je bolnik hkrati prejemal;	any interactions that have been observed with other medicinal products administered concomitantly;
(3)	3)
merilih, ki določajo izključitev nekaterih bolnikov iz preskušanj;	the criteria determining exclusion of certain patients from the trials;
(4)	4)
vseh morebitnih smrtnih primerih med preskušanjem ali med nadaljevalnim obdobjem.	any deaths which occurred during the trial or within the follow-up period.
(h)	h)
Podrobni podatki o novih kombinacijah zdravilnih učinkovin morajo biti enaki podatkom, ki se zahtevajo za nova zdravila in morajo dokazovati varnost in učinkovitost kombinacije.	Particulars concerning a new combination of medicinal substances must be identical to those required for new medicinal products and must substantiate the safety and efficacy of the combination.
(i)	i)
Obrazložiti je treba popolno ali delno opustitev podatkov. Če so rezultati, dobljeni v času preskušanj, nepričakovani, je treba opraviti dodatne predklinične toksikološke in farmakološke preskuse, ter jih ponovno preučiti.	Total or partial omission of data must be explained. Should unexpected results occur during the course of the trials, further pre clinical toxicological and pharmacological tests must be undertaken and reviewed.
(j)	j)
Če je zdravilo predvideno za dolgotrajno dajanje, se podajo podrobni podatki za vsako spremembo farmakološkega delovanja pri ponavljajočem dajanju zdravila, ter določi dolgotrajno odmerjanje.	If the medicinal product is intended for long-term administration, particulars shall be given of any modification of the pharmacological action following repeated administration, as well as the establishment of long-term dosage.
5.2.1 Poročila o biofarmacevtskih študijah	5.2.1. Reports of bio-pharmaceutics studies
Predložijo se poročila o študiji biološke uporabnosti, primerjalni biološki uporabnosti, poročila o bioekvivalenčni študiji, poročila o študiji korelacije in vitro ter in vivo, ter bioanalizne in analizne metode.	Bio-availability study reports, comparative bio-availability, bio-equivalence study reports, reports on in vitro and in vivo correlation study, and bio-analytical and analytical methods shall be provided.
Opravi se ocena biološke uporabnosti, kadar je treba dokazati bioekvivalenco za zdravilo iz člena 10(1)(a).	In addition, an assessment of bio-availability shall be undertaken where necessary to demonstrate bio-equivalence for the medicinal products referred to in Article 10 (1) (a).
5.2.2 Poročila o študijah, ki se nanašajo na farmakokinetiko ob uporabi človeških bioloških materialov	5.2.2. Reports of studies pertinent to pharmaco-kinetics using human bio-materials
V tej prilogi so človeški biološki materiali vsi proteini, celice, tkiva in sorodne snovi, ki se pridobivajo iz človeških virov in se uporabljajo in vitro ali ex vivo za presojo farmakokinetičnih lastnosti učinkovin.	For the purposes of this Annex, human bio-materials shall mean any proteins, cells, tissues and related materials derived from human sources that are used in vitro or ex vivo to assess pharmaco-kinetics properties of drug substances.
V ta namen se predložijo poročila o študiji vezave na beljakovine plazme, študijah jetrne presnove in interakcijah zdravilnih učinkovin ter študijah, ki uporabljajo druge človeške biološke materiale.	In this respect, reports of plasma protein binding study, hepatic metabolism and active substance interaction studies and studies using other human bio-materials shall be provided.
5.2.3 Poročila o farmakokinetičnih študijah pri ljudeh	5.2.3. Reports of human pharmaco-kinetic studies
(a)	a)
Opišejo se naslednje farmakokinetične lastnosti:	The following pharmaco-kinetic characteristics shall be described:
—	—
absorpcija (stopnja in obseg),	absorption (rate and extent),
—	—
porazdelitev,	distribution,
—	—
presnova,	metabolism,
—	—
izločanje.	excretion.
Opišejo se klinično pomembne značilnosti, ki vključujejo globlji pomen kinetičnih podatkov za predpisano odmerjanje, zlasti pri bolnikih s tveganjem, in razlike med človekom in živalsko vrsto, uporabljenimi v predkliničnih študijah.	Clinically significant features including the implication of the kinetic data for the dosage regimen especially for patients at risk, and differences between man and animal species used in the pre clinical studies, shall be described.
Poleg standardnih večvzorčnih farmakokinetičnih študij tudi farmakokinetične analize na skupinah ljudi na podlagi razpršenega vzorčenja med kliničnimi študijami lahko obravnavajo vprašanja o prispevanju intrinzičnih in ekstrinzičnih faktorjev k spreminjanju odnosa med odmerkom in farmakokinetičnim odzivom. Predložijo se poročila o farmakokinetičnih študijah in študijah začetnega prenašanja pri zdravih udeležencih preskušanja in pri bolnikih, poročila o farmakokinetičnih študijah za presojo učinkov intrinzičnih in ekstrinzičnih faktorjev, ter poročila o farmakokinetičnih študijah na skupini ljudi.	In addition to standard multiple-sample pharmaco-kinetics studies, population pharmaco-kinetics analyses based on sparse sampling during clinical studies can also address questions about the contributions of intrinsic and extrinsic factors to the variability in the dose- pharmaco-kinetics response relationship. Reports of pharmaco-kinetic and initial tolerability studies in healthy subjects and in patients, reports of pharmaco-kinetic studies to assess effects of intrinsic and extrinsic factors, and reports of population pharmaco-kinetic studies shall be provided.
(b)	b)
Če se bo zdravilo običajno dajalo hkrati z drugimi zdravili, se podajo podrobni podatki o preskusih skupnega dajanja zdravil, da se dokaže možna sprememba farmakološkega delovanja.	If the medicinal product is normally to be administered concomitantly with other medicinal products, particulars shall be given of joint administration tests performed to demonstrate possible modification of the pharmacological action.
Opravi se raziskava farmakokinetičnih interakcij med zdravilno učinkovino in drugimi zdravili ali snovmi.	Pharmaco-kinetic interactions between the active substance and other medicinal products or substances shall be investigated.
5.2.4 Poročila o farmakodinamičnih študijah pri ljudeh	5.2.4. Reports of human pharmaco-dynamic studies
(a)	a)
Dokaže se farmakodinamično delovanje v povezavi z učinkovitostjo, vključno:	The pharmaco-dynamic action correlated to the efficacy shall be demonstrated including:
—	—
s povezavo med odmerkom in njegovim odzivom ter časovni potek,	the dose-response relationship and its time course,
—	—
z utemeljitvijo odmerjanja in pogojev dajanja zdravila,	justification for the dosage and conditions of administration,
—	—
z načinom delovanja, če je mogoče.	the mode of action, if possible.
Opiše se farmakodinamično delovanje, ki ni povezano z učinkovitostjo.	The pharmaco-dynamic action not related to efficacy shall be described.
Dokazovanje farmakodinamičnih učinkov pri ljudeh samo po sebi še ni dovolj za utemeljitev zaključkov glede kakršnega koli posebnega potencialnega terapevtskega učinka.	The demonstration of pharmaco-dynamic effects in human beings shall not in itself be sufficient to justify conclusions regarding any particular potential therapeutic effect.
(b)	b)
Če se bo zdravilo običajno dajalo hkrati z drugimi zdravili, se podajo podrobni podatki o preskusih skupnega dajanja zdravil, da se dokaže možna sprememba farmakološkega delovanja.	If the medicinal product is normally to be administered concomitantly with other medicinal products, particulars shall be given of joint administration tests performed to demonstrate possible modification of the pharmacological action.
Opravi se raziskava farmakokinetičnih interakcij med zdravilno učinkovino in drugimi zdravili ali snovmi.	Pharmaco-dynamic interactions between the active substance and other medicinal products or substances shall be investigated.
5.2.5 Poročila o študijah učinkovitosti in varnosti	5.2.5. Reports of efficacy and safety studies
5.2.5.1 Poročila o kontroliranih kliničnih študijah, ki se nanašajo na določeno indikacijo	5.2.5.1. Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
Na splošno se klinična preskušanja, če je mogoče, opravljajo kot „kontrolirana klinična preskušanja“, naključna in kot primerna, proti placebu in proti že uveljavljenemu zdravilu z dokazano terapevtsko vrednostjo; kakršenkoli drug načrt je treba utemeljiti. Zdravljenje kontrolnih skupin se spreminja od primera do primera in je odvisno od etičnih vidikov in terapevtskega področja; tako je v nekaterih primerih morda bolje primerjati učinkovitost novega zdravila z učinkovitostjo že uveljavljenega zdravila z dokazano terapevtsko vrednostjo, kot pa z učinkom placeba.	In general, clinical trials shall be done as ‘controlled clinical trials’ if possible, randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value; any other design shall be justified. The treatment of the control groups will vary from case to case and also will depend on ethical considerations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo.
(1)	(1)
Kolikor je mogoče, in zlasti pri preskušanjih, kjer učinka zdravila ni mogoče objektivno izmeriti, je treba za preprečitev pristranskosti ukrepati tako, da se vključijo metode naključnih in slepih vzorcev.	As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps shall be taken to avoid bias, including methods of randomisation and blinding.
(2)	(2)
Protokol preskušanja mora vključevati natančen opis statističnih metod, ki se bodo uporabljale, število bolnikov ter razloge za njihovo vključitev (upoštevajoč izračune moči preskušanja), raven pomembnosti, ki se bo uporabljala, ter opis statistične enote. Dokumentirajo se ukrepi za preprečitev pristranskosti, zlasti metod naključnih vzorcev. Vključitev velikega števila posameznikov v preskušanje se ne sme šteti kot primerno nadomestilo za pravilno kontrolirano preskušanje.	The protocol of the trial must include a thorough description of the statistical methods to be employed, the number and reasons for inclusion of patients (including calculations of the power of the trial), the level of significance to be used and a description of the statistical unit. Measures taken to avoid bias, particularly methods of randomisation, shall be documented. Inclusion of a large number of subjects in a trial must not be regarded as an adequate substitute for a properly controlled trial.
Pregledajo se podatki o varnosti ob upoštevanju smernic, ki jih je objavila Komisija, posebna pozornost pa se posveti učinkom, ki so posledica sprememb odmerka ali potrebe po hkratnem zdravljenju, resnim neželenim učinkom, učinkom, ki imajo za posledico umik zdravila in smrti. Opišejo se vsi bolniki ali skupine bolnikov s povečanim tveganjem, zlasti pa se pozornost posveti potencialno ranljivim bolnikom, ki so prisotni v manjšem številu, npr. otroci, nosečnice, starejši rahlega zdravja, ljudje z izrazitimi bolezenskimi spremembami presnove ali izločanja, itd. Opiše se globlji pomen ovrednotenja varnosti za možne uporabe zdravila.	The safety data shall be reviewed taking into account guidelines published by the Commission, with particular attention to events resulting in changes of dose or need for concomitant medication, serious adverse events, events resulting in withdrawal, and deaths. Any patients or patient groups at increased risk shall be identified and particular attention paid to potentially vulnerable patients who may be present in small numbers, e.g., children, pregnant women, frail elderly, people with marked abnormalities of metabolism or excretion etc. The implication of the safety evaluation for the possible uses of the medicinal product shall be described.
5.2.5.2 Poročila o nekontroliranih kliničnih študijah analiz podatkov iz več kot ene študij in druga poročila kliničnih študijah	5.2.5.2. Study reports of uncontrolled clinical studies reports of analyses of data from more than one study and other clinical study reports
Predložijo se naslednja poročila.	These reports shall be provided.
5.2.6 Poročila o izkušnjah z zdravilom po začetku trženja	5.2.6. Reports of post-marketing experience
Če je zdravilo že pridobilo dovoljenje za promet v drugih državah, se predložijo podatki o neželenih učinkih zadevnega zdravila ter zdravil, ki vsebujejo enako(-e) zdravilno(-e) učinkovino(-e), po možnosti v povezavi s pogostnostjo uporabe.	If the medicinal product is already authorised in third countries, information shall be given in respect of adverse reactions of the medicinal product concerned and medicinal products containing the same active substance(s), in relation to the usage rates if possible.
5.2.7 Obrazci za poročanje o posameznih primerih in seznami posameznih primerov bolnikov	5.2.7. Case reports forms and individual patient listings
Ko se obrazci za poročanje o posameznih primerih in seznami posameznih primerov bolnikov predložijo v skladu z ustrezno smernico, ki jo je objavila Agencija, se predložijo in oblikujejo v enakem vrstnem redu kot poročila o kliničnih študijah in se razvrstijo po študijah.	When submitted in accordance with the relevant Guideline published by the Agency, case report forms and individual patient data listings shall be provided and presented in the same order as the clinical study reports and indexed by study.
DEL II	PART II
POSEBNE DOKUMENTACIJE ZA PRIDOBITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM IN ZAHTEVE	SPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTS
Nekatera zdravila so tako posebna, da je treba prilagoditi vse zahteve vloge za pridobitev dovoljenja za promet z zdravilom, kakor so določene v delu I te priloge. Da bi se upoštevala taka posebna stanja, vlagatelji upoštevajo ustrezno in prilagojeno obliko dokumentacije.	Some medicinal products present specific features which are such that all the requirements of the marketing authorisation application dossier as laid down in Part I of this Annex need to be adapted. To take account of these particular situations, an appropriate and adapted presentation of the dossier shall be followed by applicants.
1. DOBRO UVELJAVLJENA MEDICINSKA UPORABA	1. WELL-ESTABLISHED MEDICINAL USE
Za zdravila, katerih zdravilna(-e) učinkovina(-e) ima(-)jo, „dobro uveljavljeno medicinsko uporabo“, kakor je navedena v členu 10(1)(a)(ii), s priznano učinkovitostjo in sprejemljivo stopnjo varnosti, se uporabljajo naslednja posebna pravila.	For medicinal products the active substance(s) of which has/have a ‘well-established medicinal use’ as referred to Article 10(1)(a)(ii), with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.
Vlagatelj predloži module 1, 2 in 3, kakor je opisano v delu I te priloge.	The applicant shall submit Modules 1, 2 and 3 as described in part I of this Annex.
Pri modulih 4 in 5, se neklinične in klinične lastnosti obravnavajo v podrobni znanstveni bibliografiji.	For Modules 4 and 5, a detailed scientific bibliography shall address non-clinical and clinical characteristics.
Za dokazovanje dobro uveljavljene medicinske uporabe se uporabljajo naslednja posebna pravila:	The following specific rules shall apply in order to demonstrate the well-established medicinal use:
(a)	a)
Dejavniki, ki jih je treba upoštevati pri ugotavljanju dobro uveljavljene medicinske uporabe sestavin zdravila, so:	Factors which have to be taken into account in order to establish a well-established medicinal use of constituents of medicinal products are:
—	—
časovno obdobje, v katerem se učinkovina že uporablja,	the time over which a substance has been used,
—	—
količinski vidik uporabe učinkovine,	quantitative aspects of the use of the substance,
—	—
stopnja znanstvenega zanimanja pri uporabi učinkovine (ki se odraža v objavljeni znanstveni literaturi), ter	the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and
—	—
sovisnost znanstvenih ocen.	the coherence of scientific assessments.
Za ugotavljanje „dobro uveljavljene uporabe“ različnih učinkovin bodo za to morda potrebna različna časovna obdobja. V vsakem primeru pa časovno obdobje, potrebno za ugotavljanje dobro uveljavljene medicinske uporabe sestavine zdravila, ne sme biti krajše od enega desetletja od prve sistematične in dokumentirane uporabe učinkovine kot zdravila v Skupnosti.	Therefore different periods of time may be necessary for establishing well-established use of different substances. In any case, however, the period of time required for establishing a well established medicinal use of a constituent of a medicinal product must not be less than one decade from the first systematic and documented use of that substance as a medicinal product in the Community.
(b)	b)
Dokumentacija, ki jo vlagatelj predloži, naj vključuje vse vidike ocene varnosti in/ali učinkovitosti in mora vključevati ali se sklicevati na pregled ustrezne literature, ob upoštevanju študij pred začetkom in po začetku trženja ter objavljene znanstvene literature o izkušnjah v obliki epidemioloških študij in zlasti primerjalnih epidemioloških študij. Predložiti je treba vso dokumentacijo, ugodno ali neugodno. Glede na določbe o „dobro uveljavljeni medicinski uporabi“ je zlasti treba pojasniti, da bibliografski sklic na druge vire dokazov (študije po začetku prodaje, epidemiološke študije, itd.), in ne samo podatki o preskusih in preskušanjih, lahko služijo kot veljaven dokaz za varnost in učinkovitost zdravila, če neka uporaba zadovoljivo pojasnjuje in utemeljuje uporabo teh virov podatkov.	The documentation submitted by the applicant should cover all aspects of the safety and/or efficacy assessment and must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies. All documentation, both favourable and unfavourable, must be communicated. With respect to the provisions on ‘well-established medicinal use’ it is in particular necessary to clarify that ‘bibliographic reference’ to other sources of evidence (post marketing studies, epidemiological studies, etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily.
(c)	c)
Posebno pozornost je treba posvetiti manjkajočim podatkom in obvezno podati utemeljitev, zakaj prikaz sprejemljive stopnje varnosti in/ali učinkovitosti zadošča, čeprav nekatere študije manjkajo.	Particular attention must be paid to any missing information and justification must be given why demonstration of an acceptable level of safety and/or efficacy can be supported although some studies are lacking.
(d)	d)
V pregledih neklinične in/ali klinične dokumentacije je treba obrazložiti pomembnost vseh predloženih podatkov o zdravilu, ki se razlikuje od zdravila, namenjenega za trženje. Presoditi je treba, ali se preiskovano zdravilo lahko šteje kot podobno zdravilu, za katerega je že bila predložena vloga za pridobitev dovoljenja za promet z zdravilom, kljub obstoječim razlikam.	The non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing. A judgement must be made whether the product studied can be considered as similar to the product, for which application for a marketing authorisation has been made in spite of the existing differences.
(e)	e)
Izkušnje z drugimi zdravili po začetku trženja, ki vsebujejo enake sestavine, so posebnega pomena, zato morajo vlagatelji to še posebej poudariti.	Post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
2. BISTVENO PODOBNA ZDRAVILA	2. ESSENTIALLY SIMILAR MEDICINAL PRODUCTS
(a)	a)
Vloge na podlagi člena 10(1)(a)(i) (bistveno podobna zdravila) vključujejo podatke, opisane v modulih 1, 2 in 3 dela 1 te priloge, če je vlagatelj dobil soglasje imetnika izvirnega dovoljenja za promet z zdravilom, da se sklicuje na vsebino modulov 4 in 5.	Applications based upon Article 10(1) (a) (i) (essentially similar products) shall contain the data described in Modules 1, 2 and 3 of Part I of this Annex provided the applicant has been granted the consent of the holder of the original marketing authorisation to cross refer to the content of his Modules 4 and 5.
(b)	b)
Vloge na podlagi člena 10(1)(a)(iii) (bistveno podobna zdravila, to je generična zdravila) vključujejo podatke, opisane v modulih 1, 2 in 3 dela 1 te priloge, skupaj s podatki, ki prikazujejo biološko uporabnost in bioekvivalenco z izvirnim zdravilom, pod pogojem, da slednje ni biološko zdravilo (glejte del II, 4 Podobna biološka zdravila).	Applications based upon Article 10(1) (a) (iii) (essentially similar products i.e. generics) shall contain the data described in Modules 1, 2 and 3 of Part I of this Annex together with data showing bio-availability and bio-equivalence with the original medicinal product provided the latter is not a biological medicinal product (see Part II, 4 Similar biological medicinal products).
Pri teh zdravilih se pregledi/povzetki neklinične/klinične dokumentacije osredotočijo zlasti na naslednje elemente:	For these products the non-clinical/clinical overviews/summaries shall particularly focus on the following elements:
—	—
utemeljitve za trditev o bistveni podobnosti,	the grounds for claiming essential similarity;
—	—
povzetek nečistot, prisotnih v serijah zdravilne(-ih) učinkovine/učinkovin, ter nečistot v končnem izdelku (in kadar je to ustrezno, razgradnih produktov, ki nastajajo med shranjevanjem), kakor se predlagajo za uporabo v zdravilu, ki bo na trgu, skupaj z ovrednotenjem teh nečistot,	a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) as proposed for use in the product to be marketed together with an evaluation of these impurities;
—	—
ovrednotenje bioekvivalenčnih študij ali utemeljitev, zakaj študije niso bile izvedene glede na smernico, Raziskava biološke uporabnosti in bioekvivalenca,	an evaluation of the bio-equivalence studies or a justification why studies were not performed with respect to the guideline on ‘Investigation of Bio-availability and Bio-equivalence’;
—	—
dopolnitev objavljene literature v zvezi z učinkovino in predloženo vlogo. Ta je v obliki za ta namen označenih člankov dosegljiva v „strokovnih revijah“,	an update of published literature relevant to the substance and the present application. It may be acceptable for articles in ‘peer review’ journals to be annotated for this purpose;
—	—
vsako trditev v povzetku glavnih značilnosti zdravila, ki ni poznana ali povzeta iz lastnosti zdravila in/ali terapevtske skupine, je treba obravnavati v pregledih/povzetkih neklinične/klinične dokumentacije in utemeljiti z objavljeno literaturo in/ali dodatnimi študijami,	every claim in the summary of product characteristics not known from or inferred from the properties of the medicinal product and/or its therapeutic group should be discussed in the non clinical/clinical overviews/summaries and substantiated by published literature and/or additional studies.
—	—
če je potrebno, mora vlagatelj za dokaz trditve o bistveni podobnosti predložiti dodatne podatke, s katerimi dokazuje enakovrednost lastnosti glede varnosti in učinkovitosti različnih soli, estrov ali derivatov zdravilne učinkovine, ki je že pridobila dovoljenje za promet.	if applicable, additional data in order to demonstrate evidence on the equivalence of safety and efficacy properties of different salts, esters or derivatives of an authorised active substance should be provided by the applicant when he claims essential similarity.
3. DODATNI PODATKI, ZAHTEVANI V POSEBNIH PRIMERIH	3. ADDITIONAL DATA REQUIRED IN SPECIFIC SITUATIONS
Kadar zdravilna učinkovina bistveno podobnega zdravila vsebuje enako terapevtsko molekulo kot izvirno zdravilo, ki je že pridobilo dovoljenje za promet, povezano z različno soljo/estrskim kompleksom/derivat se prikaže dokaz, da ni nobene spremembe v farmakokinetiki molekule, farmakodinamiki in/ali v toksičnosti, ki bi lahko spremenila profil varnosti/učinkovitosti. Če ni tako, se ta povezava šteje kot nova zdravilna učinkovina.	Where the active substance of an essentially similar medicinal product contains the same therapeutic moiety as the original authorised product associated with a different salt/ester complex/derivative evidence that there is no change in the pharmaco-kinetics of the moiety, pharmaco-dynamics and/or in toxicity which could change the safety/efficacy profile shall be demonstrated. Should this not be the case, this association shall be considered as a new active substance.
Kadar je zdravilo predvideno za drugačno terapevtsko uporabo ali je v drugi farmacevtski obliki, ali se bo dajalo po različnih poteh ali v različnih odmerkih ali z različnim odmerjanjem, se predložijo rezultati ustreznih toksikoloških in farmakoloških preskusov in/ali kliničnih preskušanj.	Where a medicinal product is intended for a different therapeutic use or presented in a different pharmaceutical form or to be administered by different routes or in different doses or with a different posology, the results of appropriate toxicological and pharmacological tests and/or of clinical trials shall be provided.
4. PODOBNA BIOLOŠKA ZDRAVILA	4. SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
Določbe člena 10(1)(a)(iii) morda ne bodo zadoščale v primeru bioloških zdravil. Če podatki, ki se zahtevajo za bistveno podobna zdravila (generična zdravila) ne omogočajo prikaza podobne narave dveh bioloških zdravil, se predložijo dodatni podatki, zlasti toksikološki in klinični profil.	The provisions of Article 10(1)(a) (iii) may not be sufficient in the case of biological medicinal products. If the information required in the case of essentially similar products (generics) does not permit the demonstration of the similar nature of two biological medicinal products, additional data, in particular, the toxicological and clinical profile shall be provided.
Če vlogo za pridobitev dovoljenja za promet z zdravilom predloži neodvisni vlagatelj po izteku obdobja za varstvo podatkov in če gre za biološko zdravilo, kakor je opredeljeno v odstavku 3.2 dela I te priloge, ki se nanaša na izvirno zdravilo, ki je že pridobilo dovoljenje za promet v Skupnosti, se uporabi naslednji pristop:	When a biological medicinal product as defined in Part I, paragraph 3.2 of this Annex, which refers to an original medicinal product having been granted a marketing authorisation in the Community, is submitted for a marketing authorisation by an independent applicant after the expiry of data protection period, the following approach shall be applied.
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Podatki, ki jih je treba dostaviti, niso omejeni le na module 1, 2 in 3 (farmacevtski, kemijski in biološki podatki), ki jih dopolnjujejo podatki za bioekvivalenco in biološko uporabnost. Vrsta in količina dodatnih podatkov (to je toksikoloških in drugih nekliničnih in ustreznih kliničnih podatkov) se določi od primera do primera v skladu z ustreznimi znanstvenimi smernicami.	Information to be supplied shall not be limited to Modules 1, 2 and 3 (pharmaceutical, chemical and biological data), supplemented with bio-equivalence and bio-availability data. The type and amount of additional data (i.e. toxicological and other non-clinical and appropriate clinical data) shall be determined on a case by case basis in accordance with relevant scientific guidelines.
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Zaradi raznolikosti bioloških zdravil pristojne oblasti zahtevajo, da je treba opraviti identifikacijske študije, predvidene v modulih 4 in 5, ob upoštevanju posebne lastnosti vsakega posameznega zdravila.	Due to the diversity of biological medicinal products, the need for identified studies foreseen in Modules 4 and 5, shall be required by the competent authority, taking into account the specific characteristic of each individual medicinal product.
Splošna načela, ki jih je treba uporabljati, se obravnavajo v smernici, ki upošteva lastnosti zadevnega biološkega zdravila, in jo je objavila Agencija. Če ima izvirno zdravilo, ki je že pridobilo dovoljenje za promet, več kot eno indikacijo, je treba utemeljiti učinkovitost in varnost zdravila, za katerega se trdi, da je podobno, ali, če je potrebno, prikazati ločeno za vsako od ugotovljenih indikacij.	The general principles to be applied are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency. In case the originally authorised medicinal product has more than one indication, the efficacy and safety of the medicinal product claimed to be similar has to be justified or, if necessary, demonstrated separately for each of the claimed indications.
5. ZDRAVILA Z DOLOČENO KOMBINACIJO	5. FIXED COMBINATION MEDICINAL PRODUCTS
Vloge na podlagi člena 10(1)(b) se nanašajo na nova zdravila, proizvedena iz vsaj dveh zdravilnih učinkovin, ki predhodno še nista pridobili dovoljenja kot zdravilo z določeno kombinacijo.	Applications based upon Article 10 (1) (b) shall relate to new medicinal products made of at least two active substances not previously authorised as a fixed combination medicinal product.
Pri vlogah se za zdravilo z določeno kombinacijo predložijo celotno dokumentacijo (moduli 1 do 5). Kadar je to primerno, se predložijo podatki o mestih proizvodnje in naključnih snoveh ter ovrednotenju varnosti.	For those applications a full dossier (Modules 1 to 5) shall be provided for the fixed combination medicinal product. Where applicable, information regarding the manufacturing sites and the adventitious agents, safety evaluation shall be provided.
6. DOKUMENTACIJA ZA VLOGE V IZJEMNIH OKOLIŠČINAH	6. DOCUMENTATION FOR APPLICATIONS IN EXCEPTIONAL CIRCUMSTANCES
Če vlagatelj lahko prikaže, kakor je določeno v členu 22, da ne more predložiti obširnih podatkov o učinkovitosti in varnosti v običajnih pogojih uporabe, ker:	When, as provided for in Article 22, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:
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se z indikacijami, za katere je zadevno zdravilo predvideno, sooča tako redko, da se ne more smiselno pričakovati, da bo predložil obširne dokaze, ali	the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or
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obsežnih informacij ni mogoče predložiti zaradi trenutnega stanja znanstvenih dognanj, ali	in the present state of scientific knowledge, comprehensive information cannot be provided, or
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bi bilo zbiranje tovrstnih informacij v nasprotju s splošno sprejetimi načeli medicinske etike,	it would be contrary to generally accepted principles of medical ethics to collect such information,
se dovoljenje za promet z zdravilom lahko izda z določitvijo posebnih obveznosti.	marketing authorisation may be granted subject to certain specific obligations.
Te obveznosti lahko vključujejo naslednje:	These obligations may include the following:
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vlagatelj zaključi določen program študij v časovnem obdobju, ki ga določi pristojni organ, dobljeni rezultati pa so osnova za ponovno oceno razmerja korist/tveganje,	the applicant shall complete an identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,
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izdaja zadevnega zdravila je le na zdravniški recept in se v določenih primerih lahko daje samo pod strogim zdravniškim nadzorom, po možnosti v bolnišnici ter v primeru radiofarmacevtskih izdelkov pod nadzorom pooblaščene osebe,	the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radio-pharmaceutical, by an authorised person,
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navodilo za uporabo in vse ostale zdravstvene informacije usmerijo zdravnikovo pozornost na dejstvo, da so podrobni podatki, ki so na voljo o zadevnem zdravilu, v določenih posebnih pogledih še vedno nezadostni.	the package leaflet and any medical information shall draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
7. MEŠANE VLOGE ZA PRIDOBITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM	7. MIXED MARKETING AUTHORISATION APPLICATIONS
Mešane vloge za pridobitev dovoljenja za promet z zdravilom so vloge, pri katerih je modul 4 in/ali 5 sestavljen iz kombinacije poročil omejenih nekliničnih in/ali kliničnih študij, ki jih je vlagatelj opravil, ter sklicev na bibilografijo. Vsi ostali moduli so sestavljeni v skladu s strukturo, opisano v delu I te priloge. Pristojni organ sprejme predlagano strukturo, predloženo s strani vlagatelja, od primera do primera.	Mixed marketing-authorisation applications shall mean marketing-authorisation application dossiers where Module 4 and/or 5 consists of a combination of reports of limited non-clinical and/or clinical studies carried out by the applicant and of bibliographical references. All other Module(s) are in accordance with the structure described in Part I of this Annex. The competent authority shall accept the proposed format presented by the applicant on a case by case basis.
DEL III	PART III
POSEBNA ZDRAVILA	PARTICULAR MEDICINAL PRODUCTS
V tem delu so določene posebne zahteve v zvezi z naravo določenih zdravil.	This Part lays down specific requirements related to the nature of identified medicinal products.
1. BIOLOŠKA ZDRAVILA	1. BIOLOGICAL MEDICINAL PRODUCTS
1.1 Zdravila, pridobljena iz plazme	1.1. Plasma-derived medicinal product
Pri zdravilih, pridobljenih iz človeške krvi ali plazme in z odstopanjem od določb modula 3, se zahteve za dokumentacijo, navedene v „Podatkih o vhodnih snoveh in surovinah“, pri vhodnih snoveh, proizvedenih iz človeške krvi/plazme, lahko nadomestijo z glavno dokumentacijo o plazmi, potrjeno v skladu s tem delom.	For medicinal products derived from human blood or plasma and by derogation from the provisions of Module 3, the dossier requirements mentioned in ‘Information related to the starting and raw materials’, for starting materials made of human blood/plasma may be replaced by a Plasma Master File certified in accordance with this Part.
(a) Načela	a) Principles
Za namene te priloge:	For the purposes of this Annex:
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Glavna dokumentacija o plazmi je samostojna dokumentacija, ločena od dokumentacije za pridobitev dovoljenja za promet z zdravilom, ki zagotavlja vse pomembne podrobne podatke o lastnostih celotne človeške plazme, ki se uporablja kot vhodna snov in/ali surovina za proizvodnjo pod/vmesnih frakcij, sestavin pomožnih snovi in zdravilne(-ih) učinkovine/učinkovin, ki so del zdravil ali medicinskih pripomočkov, navedenih v Direktivi 2000/70/ES Evropskega parlamenta in Sveta z dne 16. novembra 2000 o spremembi Direktive Sveta 93/42/ES o medicinskih pripomočkih, ki vsebujejo stabilne derivate človeške krvi ali človeške plazme ( 27 ).	Plasma Master File shall mean a stand-alone documentation, which is separate from the dossier for marketing authorisation which provides all relevant detailed information on the characteristics of the entire human plasma used as a starting material and/or a raw material for the manufacture of sub/intermediate fractions, constituents of the excipient and active substance(s), which are part of medicinal products or medical devices referred to in Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or human plasma ( 27 ).
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Vsak center ali ustanova za frakcioniranje človeške plazme pripravi in dopolnjuje sklop pomembnih podrobnih podatkov, ki se nanašajo na glavno dokumentacijo o plazmi.	Every centre or establishment for fractionation/processing of human plasma shall prepare and keep updated the set of detailed relevant information referred to in the Plasma Master File.
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Vlagatelj za pridobitev dovoljenja za promet z zdravilom ali imetnik dovoljenja za promet z zdravilom glavno dokumentacijo o plazmi predloži Agenciji ali pristojnemu organu. Kadar vlagatelj za pridobitev dovoljenja za promet ali imetnik dovoljenja za promet ni imetnik glavne dokumentacije o plazmi, je ta vlagatelju ali imetniku na voljo za predložitev pristojnemu organu. V vsakem primeru vlagatelj ali imetnik dovoljenja za promet prevzameta odgovornost za zdravilo.	The Plasma Master File shall be submitted to the Agency or to the competent authority by the applicant for a marketing authorisation or the holder of the marketing authorisation. Where the applicant for a marketing authorisation or the marketing authorisation holder differs from the holder of the Plasma Master File, the Plasma Master File shall be made available to the applicant or marketing authorisation holder for submission to the competent authority. In any case, the applicant or marketing authorisation holder shall take responsibility for the medicinal product.
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Pristojni organ, ki ocenjuje dovoljenje za promet z zdravilom, pričakuje, da bo Agencija certifikat izdala pred odločitvijo o vlogi.	The competent authority that is evaluating the marketing authorisation shall await for the Agency to issue the certificate before deciding on the application.
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Vse dokumentacije za pridobitev dovoljenja, ki vključujejo sestavino, pridobljeno iz človeške plazme, se sklicujejo na glavno dokumentacijo o plazmi, ki ustreza plazmi, uporabljeni kot vhodna snov ali surovina.	Any marketing authorisation dossier containing a human plasma-derived constituent shall refer to the Plasma Master File corresponding to the plasma used as a starting/raw material.
(b) Vsebina	b) Content
V skladu z določbami člena 109, spremenjenega z Direktivo 2002/98/ES, ki se nanaša na zahteve za darovalce in preskušanje darovane plazme, glavna dokumentacija o plazmi vsebuje podatke o plazmi, uporabljeni kot vhodna snov ali surovina, zlasti:	In accordance with the provisions of Article 109, as amended by Directive 2002/98/EC, which refers to the requirements for donors and the testing of donations, the Plasma Master File shall include information on the plasma used as starting/raw material, in particular:
(1)	(1)
Izvor plazme	Plasma origin
(i)	(i)
podatke o centrih ali ustanovah, v katerih se kri/plazma zbira, vključno z inšpekcijskim pregledom in odobritvijo, ter epidemiološke podatke o infekcijah, ki so prenosljive s krvjo.	information on centres or establishments in which blood/plasma collection is carried out, including inspection and approval, and epidemiological data on blood transmissible infections.
(ii)	(ii)
podatke o centrih ali ustanovah, v katerih se izvaja preskušanje darovane plazme in zbirov plazme, vključno z inšpekcijskim pregledom in stanjem odobritve.	information on centres or establishments in which testing of donations and plasma pools is carried out, including inspection and approval status.
(iii)	(iii)
merila selekcije/izključitve darovalcev krvi/plazme.	selection/exclusion criteria for blood/plasma donors.
(iv)	(iv)
vzpostavljeni sistem, ki omogoča sledenje poti posameznih darovanih količin krvi/plazme od ustanove, kjer je bila plazma/kri zbrana, do končnega izdelka in nasprotno.	system in place which enables the path taken by each donation to be traced from the blood/plasma collection establishment through to finished products and vice versa.
(2)	(2)
Kakovost in varnost plazme	Plasma quality and safety
(i)	(i)
skladnost z monografijami Evropske farmakopeje	compliance with European Pharmacopoeia Monographs.
(ii)	(ii)
preskušanje darovane in zbrane krvi/plazme na povzročitelje infekcij, vključno s podatki o preskusnih metodah ter, pri zbiranju plazme, s podatki o validaciji uporabljenih preskusov.	testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.
(iii)	(iii)
tehnične značilnosti vrečk za zbiranje krvi in plazme, vključno s podatki o uporabljenih raztopinah antikoagulantov.	technical characteristics of bags for blood and plasma collection, including information on anticoagulants solutions used.
(iv)	(iv)
pogoji shranjevanja in transporta plazme.	conditions of storage and transport of plasma.
(v)	(v)
postopki v obdobju zadrževanja plazme pred sproščanjem („inventory hold“) in/ali obdobje karantene.	procedures for any inventory hold and/or quarantine period.
(vi)	(vi)
opis lastnosti zbira plazme.	characterisation of the plasma pool.
(3)	(3)
Sistem, vzpostavljen med proizvajalcem zdravila, pridobljenega iz plazme, in/ali frakcionarjem/predelovalcem, na eni strani, ter zbiranjem krvi/plazme in centri ali ustanovami za preskušanje, na drugi strani, ki opredeljuje pogoje njihove interakcije in dogovorjenih specifikacij.	System in place between the plasma-derived medicinal product manufacturer and/or plasma fractionator/processor on the one hand, and blood/plasma collection and testing centres or establishments on the other hand, which defines the conditions of their interaction and their agreed specifications.
V glavni dokumentaciji o plazmi se navede seznam zdravil, za katere glavna dokumentacija o plazmi velja, če so zdravila že pridobila dovoljenje za promet ali so v postopku pridobivanja dovoljenja, vključno z zdravili, navedenimi v členu 2 Direktive 2001/20/ES Evropskega parlamenta in sveta o izvajanju dobre klinične prakse pri vodenju kliničnih preskušanj zdravil za ljudi.	In addition, the Plasma Master File shall provide a list of the medicinal products for which the Plasma Master File is valid, whether the medicinal products have been granted a marketing authorisation or are in the process of being granted such an authorisation, including medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
(c) Vrednotenje in certificiranje	c) Evaluation and Certification
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Za zdravila, ki še niso pridobila dovoljenja za promet, vlagatelj za pridobitev dovoljenja pristojnemu organu predloži popolno dokumentacijo ter priloži ločen glavno dokuemntacijo o plazmi, kadar ta še ni bila predložena.	For medicinal products not yet authorised, the marketing authorisation applicant shall submit a full dossier to a competent authority, which shall be accompanied by a separate Plasma Master File where one does not already exist.
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Glavna dokumentacija o plazmi Agencija znanstveno in strokovno oceni. Pri pozitivni oceni glavna dokumentacija o plazmi prejme certifikat o skladnosti z zakonodajo Skupnosti, kateremu je priloženo poročilo o oceni. Izdani certifikat velja na celotnem območju Skupnosti.	The Plasma Master File is subject to a scientific and technical evaluation carried out by the Agency. A positive evaluation shall result in a certificate of compliance with Community legislation for the Plasma Master File, which shall be accompanied by the evaluation report. The certificate issued shall apply throughout the Community.
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Glavna dokumentacija o plazmi se vsako leto dopolnjuje z novimi podatki in ponovno certificira.	The Plasma Master File shall be updated and re-certified on an annual basis.
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Spremembe, s katerimi se dopolnjuje glavna dokumentacija o plazmi, morajo slediti postopku vrednotenja, ki ga določa Uredba Komisije (ES) št. 542/95 ( 28 ) o preučitvi sprememb dovoljenja za promet z zdravilom, ki spada v področje Uredbe Komisije (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil ( 29 ). Pogoje za ocenjevanje navedenih sprememb določa Uredba (ES) št. 1085/2003.	Changes subsequently introduced to the terms of a Plasma Master File must follow evaluation procedure laid down by Commission Regulation (EC) No 542/95 ( 28 ) concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ( 29 ). Conditions for the assessment of these changes are laid down by Regulation (EC) No 1085/2003.
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Kot drugo fazo določb iz prve, druge, tretje in četrte alinee pristojni organ, ki bo izdal ali je že izdal dovoljenje za promet z zdravilom, upošteva certificiranje, ponovno certificiranje ali spremembo glavne dokumentacije o plazmi za zadevno(a) zdravilo(a).	As a second step to the provisions in the first, second, third and fourth indents, the competent authority that will grant or has granted the marketing authorisation shall take into account the certification, re-certification or variation of the Plasma Master File on the concerned medicinal product(s).
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Z odstopanjem od odločb druge alinee te točke (vrednotenje in certificiranje), kadar je glavna dokumentacija o plazmi ustrezna le za zdravila, pridobljena iz krvi/plazme, za katera je izdano dovoljenje za promet omejeno na eno samo državo, znanstveno in strokovno ovrednotenje navedene glavne dokumentacije o plazmi izvede pristojni nacionalni organ te države članice.	By derogation from the provisions of the second indent of the present point (evaluation and certification), where a Plasma Master File corresponds only to blood/plasma-derived medicinal products the marketing authorisation of which is restricted to a single Member State, the scientific and technical evaluation of the said Plasma Master File shall be carried out by the national competent authority of that Member State.
1.2 Cepiva	1.2. Vaccines
Za cepiva za ljudi in z odstopanjem od določb modula 3 o „zdravilni(-ih) učinkovini(-ah)“ veljajo naslednje zahteve, če se zanje kot osnova uporablja glavna dokumentacija o antigenu cepiva.	For vaccines for human use and by derogation from the provisions of Module 3 on ‘Active substance(s)’, the following requirements when based on the use of a Vaccine Antigen Master File system shall apply.
Za vlogo za pridobitev dovoljenja za promet z zdravilom se za cepivo, razen za cepivo proti gripi, zahteva, da dokumentacija vključuje glavno dokumentacijo o antigenu cepiva za vsak antigen cepiva, ki je zdravilna učinkovina tega cepiva.	The marketing authorisation application dossier of a vaccine other than human influenza vaccine, shall be required to include a Vaccine Antigen Master File for every vaccine antigen that is an active substance of this vaccine.
(a) Načela	a) Principles
Za namene te priloge:	For the purposes of this Annex:
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Glavna dokumentacija o antigenu cepiva je samostojen del vloge za pridobitev dovoljenja za promet s cepivom, ki vsebuje vse pomembne podatke o biološki, farmacevtski in kemijski naravi vsake posamezne zdravilne učinkovine, ki je del navedenega zdravila. Samostojni del je lahko skupen enemu ali več monovalentnim in/ali kombiniranim cepivom, ki ga predloži isti vlagatelj ali imetnik dovoljenja za promet.	Vaccine Antigen Master File shall mean a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information of biological, pharmaceutical and chemical nature concerning each of the active substances, which are part of this medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
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Cepivo lahko vsebuje enega ali več različnih antigenov cepiva. Število zdravilnih učinkovin, prisotnih v cepivu, je enako številu antigenov, prisotnih v cepivu.	A vaccine may contain one or several distinct vaccine antigens. There are as many active substance(s) as vaccine antigen(s) present in a vaccine.
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Kombinirano cepivo vsebuje vsaj dva različna antigena cepiva, ki sta namenjena za preprečevanje ene same ali več nalezljivih bolezni.	A combined vaccine contains at least two distinct vaccine antigens aimed at preventing a single or several infectious diseases.
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Monovalentno cepivo je cepivo, ki vsebuje en antigen cepiva, namenjen za preprečevanje ene same nalezljive bolezni.	A monovalent vaccine is a vaccine, which contains one vaccine antigen aimed at preventing a single infectious disease.
(b) Vsebina	b) Content
Glavna dokumentacija o antigenu cepiva vsebuje naslednje podatke, povzete iz ustreznega dela (zdravilna učinkovina) modula 3 o „Podatkih o kakovosti“, kakor so opisani v delu I te priloge:	The Vaccine Antigen Master File shall contain the following information extracted from the relevant part (Active substance) of Module 3 on ‘Quality Data’ as delineated in Part I of this Annex:
Zdravilna učinkovina	Active Substance
1.	1.
Splošni podatki, vključno s skladnostjo z ustrezno(imi) monografijo(ami) Evropske farmakopeje.	General Information, including compliance with the relevant monograph(s) of the European Pharmacopoeia.
2.	2.
Podatki o proizvodnji zdravilne učinkovine: ta naslov mora vključevati postopek proizvodnje, podatke o vhodnih snoveh in surovinah, posebne ukrepe glede TSE in ovrednotenje varnosti glede prisotnosti naključnih snovi ter proizvodne objekte in opremo.	Information on the manufacture of the active substance: this heading must cover the manufacturing process, information on the starting and raw materials, specific measures on TSEs and adventitious agents safety evaluation and facilities and equipment.
3.	3.
Opis lastnosti zdravilne učinkovine	Characterisation of the active substance
4.	4.
Kontrola kakovosti zdravilne učinkovine	Quality control of the active substance
5.	5.
Referenčni standard in materiali	Reference standard and materials
6.	6.
Vsebnik in sistem zapiranja zdravilne učinkovine	Container and closure system of the active substance
7.	7.
Stabilnost zdravilne učinkovine.	Stability of the active substance.
(c) Vrednotenje in certificiranje	c) Evaluation and Certification
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Za nova cepiva, ki vsebujejo nov antigen cepiva, vlagatelj pristojnemu organu predloži popolno vlogo za dovoljenje za promet z zdravilom, vključno z glavno dokumentacijo o antigenu cepiva, ki ustreza vsakemu posameznemu antigenu cepiva, ki je del novega cepiva, kadar glavna dokumentacija za posamezni antigen cepiva še ne obstaja. Agencija znanstveno in strokovno ovrednoti vsako glavno dokumentacijo o antigenu cepiva. Pozitivni oceni vsake glavne dokumentacije o antigenu cepiva sledi certifikat o skladnosti z evropsko zakonodajo, kateremu je priloženo poročilo o oceni. Certifikat velja na celotnem območju Skupnosti.	For novel vaccines, which contain a novel vaccine antigen, the applicant shall submit to a competent authority a full marketing-authorisation application dossier including all the Vaccine Antigen Master Files corresponding to each single vaccine antigen that is part of the novel vaccine where no master file already exists for the single vaccine antigen. A scientific and technical evaluation of each Vaccine Antigen Master File shall be carried out by the Agency. A positive evaluation shall result in a certificate of compliance to the European legislation for each Vaccine Antigen Master File, which shall be accompanied by the evaluation report. The certificate shall apply throughout the Community.
—	—
Določbe prve alinee se uporabljajo tudi za vsako cepivo, sestavljeno iz nove kombinacije antigenov cepiva, ne glede na to, ali je ali ni eden ali več antigenov tega cepiva del cepiv, ki so že pridobila dovoljenje za promet v Skupnosti.	The provisions of the first indent shall also apply to every vaccine, which consists of a novel combination of vaccine antigens, irrespective of whether or not one or more of these vaccine antigens are part of vaccines already authorised in the Community.
—	—
Spremembe vsebine glavne dokumentacije o antigenu cepiva za cepivo, ki je že dobilo dovoljenje za promet v Skupnosti, Agencija znanstveno in strokovno ovrednoti v skladu s postopkom, določenim v Uredbi Komisije (ES) št. 1085/2003. Pri pozitivni oceni Agencija izda certifikat o skladnosti glavne dokumentacije o antigenu cepiva z zakonodajo Skupnosti. Izdani certifikat velja na celotnem območju Skupnosti.	Changes to the content of a Vaccine Antigen Master File for a vaccine authorised in the Community shall be subject to a scientific and technical evaluation carried out by the Agency in accordance with the procedure laid down in Commission Regulation (EC) No 1085/2003. In the case of a positive evaluation the Agency shall issue a certificate of compliance with Community legislation for the Vaccine Antigen Master File. The certificate issued shall apply throughout the Community.
—	—
Z odstopanjem od določb prve, druge in tretje alinee te točke (vrednotenje in certificiranje), kadar glavna dokumentacija o antigenu cepiva ustreza samo cepivu, ki je predmet dovoljenja za promet, ki še ni bilo/ki ne bo izdano po postopku Skupnosti, ter pod pogojem, da cepivo, ki je že dobilo dovoljenje, vključuje antigene cepiva, ki se še niso ovrednotili po postopku Skupnosti, pristojni nacionalni organ, ki je izdal dovoljenje za promet z zdravilom, znanstveno in strokovno ovrednoti navedeno glavno dokumentacijo o antigenu cepiva in vse poznejše spremembe dokumentacije.	By derogation from the provisions of the first, second and third indents of the present point (evaluation and certification), where a Vaccine Antigen Master File corresponds only to a vaccine which is the subject of a marketing authorisation which has not been/will not be granted according to a Community procedure, and, provided the authorised vaccine includes vaccine antigens which have not been evaluated through a Community procedure, the scientific and technical evaluation of the said Vaccine Antigen Master File and its subsequent changes, shall be carried out by the national competent authority that has granted the marketing authorisation.
—	—
Kot drugo fazo določb iz prve, druge, tretje in četrte alinee pristojni organ, ki bo izdal ali je že izdal dovoljenje za promet z zdravilom, upošteva certificiranje, ponovno certificiranje ali spremembo glavne dokumentacije o antigenu cepiva za zadevno(-a) zdravilo(-a).	As a second step to the provisions in the first, second, third and fourth indents, the competent authority that will grant or has granted the marketing authorisation shall take into account the certification, re-certification or variation of the Vaccine Antigen Master File on the concerned medicinal product(s).
2. RADIOFARMACEVTSKI IZDELKI IN PREDHODNE SESTAVINE	2. RADIO-PHARMACEUTICALS AND PRECURSORS
2.1 Radiofarmacevtski izdelki	2.1. Radio-pharmaceuticals
Za to poglavje se na podlagi členov 6(2) in 9 pri vlogi predloži popolna dokumentacija, ki vključuje naslednje posebne podatke:	For the purposes of this chapter, applications based upon Articles 6 (2) and 9 shall provide a full dossier in which the following specific details shall be included:
Modul 3	Module 3
(a)	a)
V radiofarmacevtskem kompletu, ki ga je treba, potem ko ga proizvajalec dostavi, radioaktivno označiti, se šteje za zdravilno učinkovino tisti del formulacije, ki nosi radionuklid ali ga veže nase. Pri radiofarmacevtskih kompletih opis postopka proizvodnje vključuje podrobnosti o proizvodnji kompleta ter podrobnosti o njegovi priporočeni končni pripravi za proizvodnjo radioaktivnega zdravila. Potrebne specifikacije radionuklida se opišejo, kadar je to ustrezno, v skladu s splošno monografijo ali posebnimi monografijami Evropske farmakopeje. Navedejo se tudi vse sestavine, ki so pomembne za radioaktivno označevanje. Opiše se struktura radioaktivno označene spojine.	In the context of a radio-pharmaceutical kit, which is to be radio-labelled after supply by the manufacturer, the active substance is considered to be that part of the formulation which is intended to carry or bind the radio-nuclide. The description of the manufacturing method of radio-pharmaceutical kits shall include details of the manufacture of the kit and details of its recommended final processing to produce the radioactive medicinal product. The necessary specifications of the radio-nuclide shall be described in accordance, where relevant, with the general monograph or specific monographs of the European Pharmacopoeia. In addition, any compounds essential for the radio-labelling shall be described. The structure of the radio-labelled compound shall also be described.
Pri radionuklidih je treba obravnavati vpletene jedrske reakcije.	For radio-nuclides, the nuclear reactions involved shall be discussed.
V generatorju se kot zdravilne učinkovine štejejo starševski in potomčevi radionuklidi.	In a generator, both mother and daughter radio-nuclides shall be considered as active substances.
(b)	b)
Pri radionuklidih se navede vrsta radionuklida, istovetnost izotopa, možne nečistote, nosilec, uporaba in specifična aktivnost;	Details of the nature of the radio-nuclide, the identity of the isotope, likely impurities, the carrier, the use and the specific activity shall be provided.
(c)	c)
Pri radiofarmacevtskih izdelkih vhodne snovi vključujejo obsevalne tarče.	Starting materials include irradiation target materials.
(d)	d)
Predložijo se vidiki kemijske/radiokemične čistote in njene povezave z biološko porazdelitvijo.	Considerations on chemical/radiochemical purity and its relationship to bio-distribution shall be provided.
(e)	e)
Opišejo se radionuklidna čistota, radiokemična čistota ter specifična aktivnost.	Radio-nuclide purity, radiochemical purity and specific activity shall be described.
(f)	f)
Pri generatorjih se zahtevajo podrobnosti o preskušanju starševskih in potomčevih radionuklidov. Pri eluatih generatorjev se predložijo preskusi starševskih radionuklidov in ostalih sestavin generatorskega sistema.	For generators, details on the testing for mother and daughter radio-nuclides are required. For generator-eluates, tests for mother radio-nuclides and for other constituents of the generator system shall be provided.
(g)	g)
Zahteva, da se vsebnost zdravilnih učinkovin izrazi z maso učinkovitih entitet, velja samo za radiofarmacevtske komplete. Pri radionuklidih se radioaktivnost izrazi v becquerelih, izmerjenih na določen datum, in če je to potrebno, na čas, z navedbo časovnega območja. Navede se tip sevanja.	The requirement to express the content of active substances in terms of the mass of active entities shall onlyapply to radio-pharmaceutical kits. For radio-nuclides, radioactivity shall be expressed in Becquerels at a given date and, if necessary, time with reference to time zone. The type of radiation shall be indicated.
(h)	h)
Pri kompletih specifikacije končnega izdelka vključujejo preskuse delovanja izdelkov po radioaktivnem označevanju. Vključijo se ustrezne kontrole radiokemične in radionuklidne čistote radioaktivno označene spojine. Vsaka snov, ki je bistvena za radioaktivno označevanje, se identificira in določi se ji vsebnost.	For kits, the specifications of the finished product shall include tests on performance of products after radio-labelling. Appropriate controls on radiochemical and radio-nuclidic purity of the radio-labelled compound shall be included. Any material essential for radio-labelling shall be identified and assayed.
(i)	i)
Navedejo se podatki o stabilnosti radionuklidnih generatorjev, radionuklidnih kompletov in radioaktivno označenih izdelkov. Dokumentira se stabilnost med uporabo radiofarmacevtskih izdelkov v večodmernih vialah.	Information on stability shall be given for radio-nuclide generators, radio-nuclide kits and radio-labelled products. The stability during use of radio-pharmaceuticals in multi-dose vials shall be documented.
Modul 4	Module 4
Ocenjuje se, da je pri radiofarmacevtskih izdelkih toksičnost morda povezana z odmerkom sevanja. Pri diagnostiki je to posledica uporabe radiofarmacevtskih izdelkov; pri zdravljenju je to želena lastnost. Ocena varnosti in učinkovitosti radiofarmacevtskih izdelkov obravnava zahteve za zdravila in vidike merjenja odmerkov sevanja. Dokumentira se izpostavljenost organa/tkiva sevanju. Izračunajo se ocene absorbiranega odmerka sevanja po določenem, mednarodno priznanem sistemu s posebno potjo uporabe.	It is appreciated that toxicity may be associated with a radiation dose. In diagnosis, this is a consequence of the use of radio-pharmaceuticals; in therapy, it is the property desired. The evaluation of safety and efficacy of radio-pharmaceuticals shall, therefore, address requirements for medicinal products and radiation dosimetry aspects. Organ/tissue exposure to radiation shall be documented. Absorbed radiation dose estimates shall be calculated according to a specified, internationally recognised system by a particular route of administration.
Modul 5	Module 5
Predložijo se rezultati kliničnih preskušanj, kadar je to potrebno, sicer pa se to utemelji v pregledih klinične dokumentacije.	The results of clinical trials shall be provided where applicable otherwise justified in the clinical overviews.
2.2 Predhodne sestavine radiofarmacevtskih izdelkov za radioaktivno označevanje	2.2. Radio-pharmaceutical precursors for radio-labelling purposes
V posebnem primeru predhodnih sestavin radiofarmacevtskega izdelka, ki je predviden izključno za radiaktivno označevanje, je prvi cilj navesti informacije, ki obravnavajo možne posledice slabe učinkovitosti radioaktivne oznake ali in vivo razkroja radioaktivno označenega konjugata, to je vprašanja v zvezi z učinki prostega radionuklida na bolnika. Priložiti je treba tudi ustrezne informacije o poklicnih tveganjih, to je o izpostavljenosti bolnišničnega osebja in okolja sevanju.	In the specific case of a radio-pharmaceutical precursor intended solely for radio-labelling purposes, the primary objective shall be to present information which would address the possible consequences of poor radio-labeling efficiency or in vivo dissociation of the radio-labeled conjugate, i.e. questions related to the effects produced in the patient by free radio-nuclide. In addition, it is also necessary to present relevant information relating to occupational hazards, i.e. radiation exposure to hospital staff and to the environment.
Predložijo se zlasti, kadar je to primerno, naslednje informacije:	In particular, the following information where applicable shall be provided:
Modul 3	Module 3
Določbe modula 3 se uporabljajo pri registraciji predhodnih sestavin radiofarmacevtskega izdelka, kakor so opredeljeni zgoraj (alinee od a) do i)), kadar je to primerno.	The provisions of Module 3 shall apply to the registration of radio-pharmaceutical precursors as define above (indents a) to i)), where applicable.
Modul 4	Module 4
V zvezi s toksičnostjo pri enkratnem odmerku ali pri ponavljajočih odmerkih se predložijo rezultati študij, izvedenih v skladu z določbami o dobri laboratorijski praksi, predpisanimi v direktivah Sveta 87/18/EGS in 88/320/EGS, če se ne utemeljuje na drug način.	Concerning single dose and repeat dose toxicity, the results of studies carried out in conformity with the provisions related to good laboratory practice laid down in Council Directives 87/18/EEC and 88/320/EEC shall be provided, unless otherwise justified.
Študije mutagenosti radionuklidov se v tem posebnem primeru ne ocenjujejo kot koristne.	Mutagenicity studies on the radio-nuclide are not considered to be useful in this particular case.
Predložijo se podatki o kemični toksičnosti in stanju ustreznega, hladnega „nuklida.“	Information relating to the chemical toxicity and disposition of the relevant ‘cold’ nuclide shall be presented.
Modul 5	Module 5
Klinični podatki, pridobljeni iz kliničnih študij z uporabo predhodne sestavine same, se ne ocenjujejo kot primerni za ta poseben primer predhodne sestavine radiofarmacevtskega izdelka, predvidenega izključno za radioaktivno označevanje.	Clinical information generated from clinical studies using on the precursor itself is not considered to be relevant in the specific case of a radio-pharmaceutical precursor intended solely for radio-labelling purposes.
Priložijo pa se podatki, ki prikazujejo klinično koristnost predhodne sestavine radiofarmacevtskega izdelka, kadar je pritrjen na molekule ustreznega nosilca.	However, information demonstrating the clinical utility of the radio-pharmaceutical precursor when attached to relevant carrier molecules shall be presented.
3. HOMEOPATSKA ZDRAVILA	3. HOMEOPATHIC MEDICINAL PRODUCTS
V tem oddelku so navedene posebne zahteve o uporabi modulov 3 in 4 za homeoptska zdravila, opredeljena v členu 1(5).	This section sets out specific provisions on the application of Modules 3 and 4 to homeopathic medicinal products as defined in Article 1(5).
Modul 3	Module 3
Določbe modula 3 se uporabljajo za dokumente, predložene v skladu s členom 15 pri poenostavljeni registraciji homeopatskih zdravil iz člena 14(1), kot tudi za dokumente za pridobitev dovoljenja za druga homeopatska zdravila iz člena 16(1) z naslednjimi spremembami.	The provisions of Module 3 shall apply to the documents submitted in accordance with Article 15 in the simplified registration of homeopathic medicinal products referred to in Article 14(1) as well as to the documents for authorisation of other homeopathic medicinal products referred to in Article 16(1) with the following modifications.
(a)	a)
Terminologija	Terminology
Latinsko ime homeopatske osnove, opisane v vlogi za pridobitev dovoljenja za promet z zdravilom, mora biti v skladu z latinskim naslovom v Evropski farmakopeji, ali, če tega ni, z uradno farmakopejo države članice. Kadar je to primerno, se navede(jo) tradicionalno(a) ime(na), ki se uporablja(jo) v posameznih državah članicah.	The Latin name of the homeopathic stock described in the marketing authorisation application dossier must be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, by an official pharmacopoeia of a Member State. Where relevant the traditional name(s) used in each Member State shall be provided.
(b)	b)
Kontrola vhodnih snovi	Control of starting materials
Podrobni podatki in dokumenti o vhodnih snoveh, to je o vseh uporabljenih snoveh, vključno s surovinami in intermediati do končnih razredčin, ki bodo vključene v končni izdelek, ki spremljajo vlogo, se dopolnijo z dodatnimi podatki o homeopatski snovi.	The particulars and documents on the starting materials, i.e. all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished medicinal product, accompanying the application shall be supplemented by additional data on the homeopathic stock.
Splošne zahteve za kakovost se uporabljajo za vse vhodne snovi in surovine, ter za vmesne faze postopka proizvodnje do končne razredčine, ki bo vključena v končni izdelek. Če je mogoče, se zahteva določitev vsebnosti, če so prisotne toksične sestavine in če kakovosti pri končni razredčini, ki bo vključena, ni mogoče kontrolirati zaradi visoke stopnje razredčevanja. V celoti je treba opisati vsako fazo postopka proizvodnje od vhodnih snovi do končne razredčine, ki bo vključena v končni izdelek.	The general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished medicinal product. If possible, an assay is required if toxic components are present and if the quality cannot be controlled on final dilution to be incorporated because of the high dilution degree. Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished medicinal product must be fully described.
Če so vključene razredčine, se stopnje razredčitve pripravijo v skladu s homeopatskimi metodami proizvodnje, določenimi v ustrezni monografiji Evropske farmakopeje ali, če te ni, v uradni farmakopeji države članice.	In case dilutions are involved, these dilution steps should be done in accordance with the homeopathicmanufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, by an official pharmacopoeia of a Member State.
(c)	c)
Kontrolni preskusi končnega izdelka	Control tests on the finished medicinal product
Za končni homeopatski izdelek se uporabljajo splošne zahteve o kakovosti, kakršno koli izjemo mora vlagatelj ustrezno utemeljiti.	The general quality requirements shall apply to the homeopathic finished medicinal products, any exception needs to be duly justified by the applicant.
Izvede se identifikacija in določitev vsebnosti vseh toksikološko pomembnih sestavin. Če je mogoče utemeljiti, da identifikacija in/ali določitev vsebnosti vseh toksikološko pomembnih sestavin ni možna, npr. zaradi njihove razredčitve v končnem izdelku, se kakovost prikaže s popolno validacijo postopka proizvodnje in razredčevanja.	Identification and assay of all the toxicologically relevant constituents shall be carried out. If it can be justified that an identification and/or an assay on all the toxicologically relevant constituents is not possible e.g. due to their dilution in the finished medicinal product the quality shall be demonstrated by complete validation of the manufacturing and dilution process.
(d)	d)
Preskusi stabilnosti	Stability tests
Dokazati je treba stabilnost končnega izdelka. Podatke o stabilnosti homeopatskih snovi se običajno lahko prenese na razredčine/trituracije, pridobljene iz snovi. Če identifikacija ali določitev vsebnosti zdravilne učinkovine ni mogoča zaradi stopnje razredčitve, se lahko upoštevajo podatki o stabilnosti farmacevtske oblike.	The stability of the finished medicinal product must be demonstrated. Stability data from the homeopathic stocks are generally transferable to dilutions/triturations obtained thereof. If no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered.
Modul 4	Module 4
Določbe modula 4 se uporabljajo za poenostavljeno registracijo homeopatskih zdravil iz člena 14(1) z naslednjimi specifikacijami.	The provisions of Module 4 shall apply to the simplified registration of homeopathic medicinal products referred to in Article 14(1) with the following specifications.
Če katerikoli podatki manjkajo, je to treba utemeljiti, npr. utemeljitev je treba podati, zakaj je mogoče dokazati sprejemljivo stopnjo varnosti, čeprav nekatere študije manjkajo.	Any missing information must be justified, e.g., justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.
4. ZDRAVILA RASTLINSKEGA IZVORA	4. HERBAL MEDICINAL PRODUCTS
Za vloge za zdravila rastlinskega izvora se predloži popolna dokumentacija, ki vključuje naslednje posebne podrobnosti.	Applications for herbal medicinal products shall provide a full dossier in which the following specific details shall be included.
Modul 3	Module 3
Za dovoljenje za promet z zdravilom rastlinskega izvora se uporabljajo določbe modula 3, vključno s skladnostjo z monografijo(-ami) Evropske farmakopeje. V času predložitve vloge se upošteva stanje znanstvenih dognanj.	The provisions of Module 3, including compliance with monograph(s) of the European Pharmacopoeia, shall apply to the authorisation of herbal medicinal products. The state of scientific knowledge at the time when the application is lodged shall be taken into account.
Upoštevajo se naslednji posebni vidiki zdravil rastlinskega izvora:	The following aspects specific to herbal medicinal products shall be considered:
(1) Rastlinske snovi in rastlinski pripravki	(1) Herbal substances and herbal preparations
V tej prilogi se izraza „rastlinske snovi in rastlinski pripravki“ štejejo za enakovredne izrazoma „posušeni deli rastlin in rastlinski pripravki iz posušenih delov rastlin“, kakor je opredeljeno v Evropski farmakopeji.	For the purposes of this Annex the terms ‘herbal substances and preparations’ shall be considered equivalent to the terms ‘herbal drugs and herbal drug preparations’, as defined in the European Pharmacopoeia.
V zvezi z nomenklaturo rastlinske snovi se navedejo binominalno znanstveno ime rastline (rod, vrsta, varieteta in avtor) in kemijska vrsta (kadar je ustrezno), deli rastlin, definicija rastlinske snovi, druga imena (sopomenke, navedene v drugih farmakopejah) ter laboratorijska oznaka.	With respect to the nomencRlature of the herbal substance, the binomial scientific name of plant (genus, species, variety and author), and chemotype (where applicable), the parts of the plants, the definition of the herbal substance, the other names (synonyms mentioned in other Pharmacopoeias) and the laboratory code shall be provided.
V zvezi nomenklaturo rastlinskega pripravka se navedejo binominalno znanstveno ime rastline (rod, vrsta, varieteta in avtor) in kemijska vrsta (kadar je ustrezno), deli rastlin, definicija rastlinskega pripravka, vsebnost rastlinske snovi v rastlinskem pripravku, topilo(-a) za ekstrakcijo, druga imena (sopomenke, navedene v drugih farmakopejah) ter laboratorijska oznaka.	With respect to the nomenclature of the herbal preparation, the binomial scientific name of plant (genus, species, variety and author), and chemotype (where applicable), the parts of the plants, the definition of the herbal preparation, the ratio of the herbal substance to the herbal preparation, the extraction solvent(s), the other names (synonyms mentioned in other Pharmacopoeias) and the laboratory code shall be provided.
Za dokumentiranje oddelka o sestavi rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov) se predložijo, kadar je to primerno, fizična oblika, opis sestavin z znanim terapevtskim delovanjem ali označevalci (molekulska formula, relativna molekulska masa, strukturna formula, vključno z relativno in absolutno stereokemijo), ter druga(-e) sestavina(-e).	To document the section of the structure for herbal substance(s) and herbal preparation(s) where applicable, the physical form, the description of the constituents with known therapeutic activity or markers (molecular formula, relative molecular mass, structural formula, including relative and absolute stereo-chemistry, the molecular formula, and the relative molecular mass) as well as other constituent(s) shall be provided.
Za dokumentiranje oddelka o proizvajalcu rastlinske snovi se navedejo, kadar je to primerno, ime, naslov in odgovornost vsakega dobavitelja, vključno s pogodbeniki, ter vsaka predlagana lokacija ali objekt, vključen v proizvodnjo/nabiranje in preskušanje rastlinske snovi.	To document the section on the manufacturer of the herbal substance, the name, address, and responsibility of each supplier, including contractors, and each proposed site or facility involved in production/collection and testing of the herbal substance shall be provided, where appropriate.
Za dokumentiranje oddelka o proizvajalcu rastlinskega pripravka se navedejo, kadar je to primerno, ime, naslov in odgovornost vsakega proizvajalca, vključno s pogodbeniki, ter vsaka predlagana lokacija ali objekt, vključen v proizvodnjo in preskušanje rastlinskega pripravka.	To document the section on the manufacturer of the herbal preparation, the name, address, and responsibility of each manufacturer, including contractors, and each proposed manufacturing site or facility involved in manufacturing and testing of the herbal preparation shall be provided, where appropriate.
V zvezi z opisom postopka proizvodnje rastlinske snovi in kontrol postopka se predložijo informacije, ki ustrezno opisujejo pridelavo in nabiranje rastlin, vključno z geografskim izvorom zdravilne rastline in pogoje gojenja, pridelovanja, sušenja in shranjevanja.	With respect to the description of manufacturing process and process controls for the herbal substance, information shall be provided to adequately describe the plant production and plant collection, including the geographical source of the medicinal plant and cultivation, harvesting, drying and storage conditions.
V zvezi z opisom postopka proizvodnje rastlinskega pripravka in kontrol postopkov, se predložijo informacije, ki ustrezno opisujejo postopek proizvodnje rastlinskega pripravka, vključno z opisom predelave, topil in reagentov, faz čiščenja in standardizacije.	With respect to the description of manufacturing process and process controls for the herbal preparation, information shall be provided to adequately describe the manufacturing process of the herbal preparation, including description of the processing, solvents and reagents, purification stages and standardisation.
V zvezi z razvojem postopka proizvodnje se navede kratek povzetek, ki opisuje razvoj rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kadar je to primerno, ob upoštevanju predlagane poti dajanja in uporabe. Obravnavajo se, kjer je to primerno, rezultati primerjave fitokemične sestave rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno, iz bibliografskih podatkov ter rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno, ki jih kot zdravilno(-e) učinkovino(-e) vsebuje zdravilo rastlinskega izvora, ki je predmet vloge.	With respect to the manufacturing process development, a brief summary describing the development of the herbal substance(s) and herbal preparation(s) where applicable shall be provided, taking into consideration the proposed route of administration and usage. Results comparing the phyto-chemical composition of the herbal substance(s) and herbal preparation(s) where applicable used in supporting bibliographic data and the herbal substance(s) and herbal preparation(s), where applicable, contained as active substance(s) in the herbal medicinal product applied for shall be discussed, where appropriate.
Za obrazložitev sestave in drugih lastnosti rastlinske snovi se navedejo podatki o botaničnem, makroskopskem, mikroskopskem, fitokemičnem opisu lastnosti, ter biološki aktivnosti, če je potrebno.	With respect to the elucidation of the structure and other characteristics of the herbal substance, information on the botanical, macroscopical, microscopical, phyto-chemical characterisation, and biological activity if necessary, shall be provided.
Za obrazložitev sestave in drugih lastnosti rastlinskega pripravka se navedejo podatki o fitokemičnem in fizikalnokemijskem opisu lastnosti, ter biološki aktivnosti, če je potrebno.	With respect to the elucidation of the structure and other characteristics of the herbal preparation, information on the phyto- and physicochemical characterisation, and biological activity if necessary, shall be provided.
Predložijo se specifikacije za rastlinsko(-e) snov(-i) in rastlinski(-e) pripravek(-e), kjer je primerno.	The specifications for the herbal substance(s) and herbal preparation(s) where applicable shall be provided.
Predložijo se analizni postopki, ki se uporabljajo za preskuse rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno.	The analytical procedures used for testing the herbal substance(s) and herbal preparation(s) where applicable shall be provided.
Predloži se validacija analiznih postopkov, podatki o validaciji analize, vključno s podatki poskusov za analizne postopke za preskušanje rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno.	With respect to the validation of analytical procedures, analytical validation information, including experimental data for the analytical procedures used for testing the herbal substance(s) and herbal preparation(s) where applicable shall be provided.
Za analize serij se predloži opis serij in rezultati analiz serij za rastlinsko(-e) snov(-i) in rastlinski(-e) pripravek(-e), kjer je primerno, vključno z analizami za snovi iz farmakopeje.	With respect to batch analyses, description of batches and results of batch analyses for the herbal substance(s) and herbal preparation(s) where applicable shall be provided, including those for pharmacopoeial substances.
Predloži se utemeljitev za specifikacije rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno.	Justification for the specifications of the herbal substance(s) and herbal preparation(s) where applicable shall be provided.
Predložijo se podatki o referenčnih standardih ali referenčnih snoveh, uporabljenih za preskušanje rastlinske(-ih) snovi in rastlinskega(-ih) pripravka(-ov), kjer je primerno.	Information on the reference standards or reference materials used for testing of the herbal substance(s) and herbal preparation(s) where applicable shall be provided.
Kadar je rastlinska snov ali rastlinski pripravek predmet monografije, vlagatelj lahko zaprosi za certifikat ustreznosti, ki ga je izdala Evropska direkcija za kakovost zdravil.	Where the herbal substance or the herbal preparation is the subject of a monograph, the applicant can apply for a certificate of suitability that was granted by the European Directorate for the Quality of Medicines.
(2) Zdravila rastlinskega izvora	(2) Herbal Medicinal Products
V zvezi z razvojem formulacije je treba predložiti kratek povzetek, ki opisuje razvoj zdravila rastlinskega izvora ob upoštevanju predlagane poti dajanja in uporabe. Kadar je to primerno, se obravnavajo rezultati primerjave fitokemične sestave izdelkov iz bibliografskih podatkov ter zdravila rastlinskega izvora, ki je predmet vloge.	With respect to the formulation development, a brief summary describing the development of the herbal medicinal product should be provided, taking into consideration the proposed route of administration and usage. Results comparing the phyto-chemical composition of the products used in supporting bibliographic data and the herbal medicinal product applied for shall be discussed, where appropriate.
5. ZDRAVILA SIROTE	5. ORPHAN MEDICINAL PRODUCTS
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Za zdravila sirote v smislu Uredbe (ES) št. 141/2000 se lahko uporabljajo splošne določbe dela II-6 (izjemne okoliščine). Vlagatelj nato v nekliničnih in kliničnih povzetkih utemelji razloge, zaradi katerih ni mogoče predložiti popolnih podatkov in utemelji stanje razmerja med koristjo in tveganjem pri zadevnem zdravilu siroti.	In the case of an orphan medicinal product in the meaning of Regulation (EC) No 141/2000, general provisions of Part II-6 (exceptional circumstances) can be applied. The applicant shall then justify in the non-clinical and clinical summaries the reasons for which it is not possible to provide the complete information and shall provide a justification of the benefit/risk balance for the orphan medicinal product concerned.
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Če se vlagatelj vloge za pridobitev dovoljenja za promet z zdravilom siroto sklicuje na določbe člena 10(1)(a)(ii) in del II-1 te priloge (dobro uveljavljena medicinska uporaba), se sistematična in dokumentirana uporaba zadevne snovi lahko sklicuje – kot odstopanje – na uporabo te snovi v skladu z določbami člena 5 te direktive.	When an applicant for an marketing authorisation for an orphan medicinal product invokes the provisions of Article 10 (1)(a)(ii) and Part II-1 of this Annex (well-established medicinal use), the systematic and documented use of the concerned substance can refer — as way of derogation — to the use of that substance in accordance with the provisions of Article 5 of this Directive.
▼M9	▼M9
DEL IV	PART IV
ZDRAVILA ZA NAPREDNO ZDRAVLJENJE	ADVANCED THERAPY MEDICINAL PRODUCTS
1. UVOD	1. INTRODUCTION
Vloge za pridobitev dovoljenja za promet z zdravili za napredno zdravljenje, kot so opredeljene v členu 2(1)(a) Uredbe (ES) št. 1394/2007, upoštevajo zahteve v zvezi s strukturo (moduli 1, 2, 3, 4 in 5) iz dela I te priloge.	Marketing authorisation applications for advanced therapy medicinal products, as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007, shall follow the format requirements (Modules 1, 2, 3, 4 and 5) described in Part I of this Annex.
Za biološka zdravila se uporabljajo tehnične zahteve za module 3, 4 in 5, kot je navedeno v delu I te priloge. Posebne zahteve za zdravila za napredno zdravljenje, ki so navedene v oddelkih 3, 4 in 5 tega dela, pojasnjujejo način uporabe zahtev iz dela I za zdravila za napredno zdravljenje. Kadar je ustrezno, se ob upoštevanju posebnosti zdravil za napredno zdravljenje poleg tega določijo tudi dodatne zahteve.	The technical requirements for Modules 3, 4 and 5 for biological medicinal products, as described in Part I of this Annex, shall apply. The specific requirements for advanced therapy medicinal products described in sections 3, 4 and 5 of this part explain how the requirements in Part I apply to advanced therapy medicinal products. In addition, where appropriate and taking into account the specificities of advanced therapy medicinal products, additional requirements have been set.
Zaradi posebnih lastnosti zdravil za napredno zdravljenje se lahko uporablja pristop, ki temelji na analizi tveganja, da se določijo kakovost ter neklinični in klinični podatki, ki jih je treba v skladu z znanstvenimi smernicami o kakovosti, varnosti in učinkovitosti zdravil iz točke 4 poglavja „Uvod in splošna načela“ vključiti v vlogo za pridobitev dovoljenja za promet z zdravilom.	Due to the specific nature of advanced therapy medicinal products, a risk-based approach may be applied to determine the extent of quality, non-clinical and clinical data to be included in the marketing authorisation application, in accordance with the scientific guidelines relating to the quality, safety and efficacy of medicinal products referred to in point 4 of the ‘Introduction and general principles’.
Analiza tveganja lahko zajame razvoj v celoti. Dejavniki tveganja, ki se lahko upoštevajo, vključujejo: izvor celic (avtologne, alogenske, ksenogenske), sposobnost za razmnoževanje in/ali razlikovanje ter sprožitev imunskega odziva, stopnjo manipulacije celic, kombinacijo celic in bioaktivnih molekul ali strukturnih materialov, lastnost zdravil za gensko zdravljenje, obseg sposobnosti uporabljenih virusov in mikroorganizmov za razmnoževanje in vivo, stopnjo vključevanja verig nukleinskih kislin ali genov v genom, dolgotrajno funkcionalnost, tveganje za rakotvornost in način dajanja ali uporabe.	The risk analysis may cover the entire development. Risk factors that may be considered include: the origin of the cells (autologous, allogeneic, xenogeneic), the ability to proliferate and/or differentiate and to initiate an immune response, the level of cell manipulation, the combination of cells with bioactive molecules or structural materials, the nature of the gene therapy medicinal products, the extent of replication competence of viruses or micro-organisms used in vivo, the level of integration of nucleic acids sequences or genes into the genome, the long time functionality, the risk of oncogenicity and the mode of administration or use.
V analizi tveganja se lahko upoštevajo tudi ustrezni dostopni neklinični in klinični podatki ali izkušnje z drugimi sorodnimi zdravili za napredno zdravljenje.	Relevant available non-clinical and clinical data or experience with other, related advanced therapy medicinal products may also be considered in the risk analysis.
Vsako odstopanje od zahtev iz te priloge se znanstveno utemelji v modulu 2 vloge za pridobitev dovoljenja za promet z zdravilom. Kadar se uporabi navedena analiza tveganja, se prav tako vključi in opiše v modulu 2. V tem primeru se obravnavajo uporabljena metodologija, ugotovljena tveganja in posledice pristopa, ki temelji na oceni tveganja, za razvoj in ovrednotenje programa ter opišejo vsa odstopanja od zahtev iz te priloge zaradi analize tveganja.	Any deviation from the requirements of this Annex shall be scientifically justified in Module 2 of the application dossier. The risk analysis described above, when applied, shall also be included and described in Module 2. In this case, the methodology followed, the nature of the identified risks and the implications of the risk based approach for the development and evaluation program shall be discussed and any deviations from the requirements of this Annex resulting from the risk analysis shall be described.
2. OPREDELITVE	2. DEFINITIONS
V tej prilogi se poleg opredelitev iz Uredbe (ES) št. 1394/2007 uporabljajo tudi opredelitve iz oddelkov 2.1 in 2.2.	For the purposes of this Annex, in addition to the definitions laid down in Regulation (EC) No 1394/2007, the definitions set out in sections 2.1 and 2.2 shall apply.
2.1 Zdravilo za gensko zdravljenje	2.1. Gene therapy medicinal product
Zdravilo za gensko zdravljenje pomeni biološko zdravilo z naslednjimi lastnostmi:	Gene therapy medicinal product means a biological medicinal product which has the following characteristics:
(a)	(a)
vsebuje zdravilno učinkovino, ki vsebuje ali je sestavljena iz rekombinantne nukleinske kisline, ki se uporablja pri ljudeh ali daje ljudem za urejanje, popravljanje, nadomestitev, dodajanje ali odstranitev genskega zaporedja;	it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
(b)	(b)
njegov zdravilen, preprečevalen ali diagnostičen učinek zadeva neposredno zaporedje rekombinantne nukleinske kisline, ki ga vsebuje, ali proizvod izražanja genov tega zaporedja.	its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
Zdravila za gensko zdravljenje ne vključujejo cepiv proti nalezljivim boleznim.	Gene therapy medicinal products shall not include vaccines against infectious diseases.
2.2 Zdravilo za somatsko celično zdravljenje	2.2. Somatic cell therapy medicinal product
Zdravilo za somatsko celično zdravljenje pomeni biološko zdravilo z naslednjimi lastnostmi:	Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
(a)	(a)
vsebuje ali je sestavljeno iz celic ali tkiv, ki so bila podvržena bistveni manipulaciji, s čimer so se spremenile njihove biološke značilnosti, fiziološke funkcije ali strukturne lastnosti, pomembne za predvideno klinično uporabo, ali iz celic ali tkiv, ki niso predvidena za uporabo za enake bistvene funkcije v prejemniku in darovalcu;	contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
(b)	(b)
ima lastnosti za ljudi ali se uporablja pri ljudeh ali se daje ljudem za zdravljenje, preprečevanje ali diagnosticiranje bolezni s farmakološkim, imunološkim ali presnovnim delovanjem celic ali tkiv.	is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.
Za namene točke (a) se kot bistvene manipulacije ne štejejo zlasti manipulacije iz Priloge I k Uredbi (ES) št. 1394/2007.	For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations.
3. POSEBNE ZAHTEVE V ZVEZI Z MODULOM 3	3. SPECIFIC REQUIREMENTS REGARDING MODULE 3
3.1 Posebne zahteve za vsa zdravila za napredno zdravljenje	3.1. Specific requirements for all advanced therapy medicinal products
Predloži se opis sistema sledljivosti, ki ga namerava vzpostaviti in vzdrževati imetnik dovoljenja za promet z zdravili, da se prek virov, izdelave, pakiranja, shranjevanja, transporta in dostave bolnišnici, instituciji ali zasebni praksi, v kateri se izdelek uporablja, zagotovi sledljivost posameznega izdelka ter vhodnih snovi in surovin, vključno z vsemi snovmi, ki prihajajo v stik s celicami ali tkivi, ki jih lahko vsebuje.	A description of the traceability system that the marketing authorisation holder intends to establish and maintain to ensure that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used, shall be provided.
Sistem sledljivosti mora dopolnjevati in biti v skladu z zahtevami iz Direktive 2004/23/ES Evropskega parlamenta in Sveta ( 30 ) v zvezi s človeškimi celicami in tkivi, razen krvnih celic, ter zahtevami iz Direktive 2002/98/ES v zvezi s krvnimi celicami človeškega izvora.	The traceability system shall be complementary to, and compatible with, the requirements established in Directive 2004/23/EC of the European Parliament and of the Council ( 30 ), as regards human cells and tissues other than blood cells, and Directive 2002/98/EC, as regards human blood cells.
3.2 Posebne zahteve za zdravila za gensko zdravljenje	3.2. Specific requirements for gene therapy medicinal products
3.2.1 Uvod: končni izdelek, zdravilna učinkovina in vhodne snovi	3.2.1. Introduction: finished product, active substance and starting materials
3.2.1.1 Zdravilo za gensko zdravljenje, ki vsebuje rekombinantna zaporedja nukleinskih kislin ali gensko spremenjene mikroorganizme ali viruse.	3.2.1.1. Gene therapy medicinal product containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)
Končno zdravilo vsebuje zaporedja nukleinskih kislin ali gensko spremenjene mikroorganizme ali viruse, ki so pripravljeni v končnem stičnem vsebniku za predvideno medicinsko uporabo. Končno zdravilo se lahko kombinira z medicinskim pripomočkom ali aktivnim medicinskim pripomočkom za vsaditev.	The finished medicinal product shall consist of nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es) formulated in their final immediate container for the intended medical use. The finished medicinal product may be combined with a medical device or active implantable medical device.
Zdravilna učinkovina vsebuje zaporedja nukleinskih kislin ali gensko spremenjene mikroorganizme ali viruse.	The active substance shall consist of nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es).
3.2.1.2 Zdravilo za gensko zdravljenje, ki vsebuje gensko spremenjene celice	3.2.1.2. Gene therapy medicinal product containing genetically modified cells
Končno zdravilo vsebuje gensko spremenjene celice, ki so pripravljene v končnem stičnem vsebniku za predvideno medicinsko uporabo. Končno zdravilo se lahko kombinira z medicinskim pripomočkom ali aktivnim medicinskim pripomočkom za vsaditev.	The finished medicinal product shall consist of genetically modified cells formulated in the final immediate container for the intended medical use. The finished medicinal product may be combined with a medical device or active implantable medical device.
Zdravilna učinkovina je sestavljena iz celic, ki jih gensko spremeni eden od izdelkov, opisanih v oddelku 3.2.1.1.	The active substance shall consist of cells genetically modified by one of the products described in section 3.2.1.1 above.
3.2.1.3 \| Če izdelki vsebujejo viruse ali virusne vektorje, so vhodne snovi sestavine, iz katerih se pridobi virusni vektor, tj. glavni sev virusnega vektorja ali plazmidi, ki se uporabljajo za transfekcijo pakirnih celic, in glavna celična banka celične linije za pakiranje.	3.2.1.3. \| In the case of products consisting of viruses or viral vectors, the starting materials shall be the components from which the viral vector is obtained, i.e. the master virus vector seed or the plasmids used to transfect the packaging cells and the master cell bank of the packaging cell line.
3.2.1.4 \| Če vsebujejo izdelki plazmide, nevirusne vektorje in gensko spremenjene mikroorganizme, ki niso virusi ali virusni vektorji, so vhodne snovi sestavine, ki se uporabljajo za pridobitev celice proizvajalke, tj. plazmid, bakterije gostiteljice in glavna celična banka rekombinantnih mikrobnih celic.	3.2.1.4. \| In the case of products consisting of plasmids, non-viral vectors and genetically modified microorganism(s) other than viruses or viral vectors, the starting materials shall be the components used to generate the producing cell, i.e. the plasmid, the host bacteria and the master cell bank of recombinant microbial cells.
3.2.1.5 \| Če so celice gensko spremenjene, so vhodne snovi sestavine, ki se uporabljajo pri pridobivanju gensko spremenjenih celic, tj. vhodne snovi za pridobivanje vektorjev, vektorskih in človeških ali živalskih celic. Načela dobre proizvodne prakse se uporabljajo od sistema banke, ki se uporablja pri pridobivanju vektorja.	3.2.1.5. \| In the case of genetically modified cells, the starting materials shall be the components used to obtain the genetically modified cells, i.e. the starting materials to produce the vector, the vector and the human or animal cells. The principles of good manufacturing practice shall apply from the bank system used to produce the vector onwards.
3.2.2 Posebne zahteve	3.2.2. Specific requirements
Poleg zahtev iz oddelkov 3.2.1 in 3.2.2 dela I te priloge se uporabljajo tudi naslednje zahteve:	In addition to the requirements set out in sections 3.2.1 and 3.2.2 of Part I of this Annex, the following requirements shall apply:
(a)	(a)
Predložijo se informacije o vseh vhodnih snoveh, ki se uporabljajo pri izdelavi zdravilnih učinkovin, vključno z izdelki, ki so potrebni za gensko spremembo človeških ali živalskih celic ter, kadar je ustrezno, za nadaljnje gojenje in shranjevanje gensko spremenjenih celic, pri čemer se upošteva, da se prečiščevanje morda ni izvedlo.	information shall be provided on all the starting materials used for the manufacture of the active substance, including the products necessary for the genetic modification of human or animal cells and, as applicable, subsequent culture and preservation of the genetically modified cells, taking into consideration the possible absence of purification steps;
(b)	(b)
Za izdelke, ki vsebujejo mikroorganizem ali virus, se navedejo podatki o genski spremembi, analizi zaporedja, slabljenju virulence, tropizmu za posebne vrste celic in tkiv, odvisnosti celičnega ciklusa od mikroorganizma ali virusa, patogenosti in lastnostih starševskega seva.	for products containing a microorganism or a virus, data on the genetic modification, sequence analysis, attenuation of virulence, tropism for specific tissues and cell types, cell cycle dependence of the microorganism or virus, pathogenicity and characteristics of the parental strain shall be provided;
(c)	(c)
V ustreznih delih vloge se opišejo nečistote, povezane s postopkom in izdelkom, ter zlasti virusni kontaminanti, sposobni za razmnoževanje, če vektor ni sposoben za razmnoževanje.	process-related impurities and product-related impurities shall be described in the relevant sections of the dossier, and in particular replication competent virus contaminants if the vector is designed to be replication incompetent;
(d)	(d)
Pri plazmidih se med celotnim rokom uporabnosti izdelka določa količina različnih oblik plazmidov.	for plasmids, quantification of the different plasmid forms shall be undertaken throughout the shelf life of the product;
(e)	(e)
Pri gensko spremenjenih celicah se preskušajo lastnosti celic pred gensko spremembo in po njej ter pred postopkom zamrzovanja/hranjenja in po vsakem nadaljnjem takem postopku.	for genetically modified cells, the characteristics of the cells before and after the genetic modification, as well as before and after any subsequent freezing/storage procedures, shall be tested.
Poleg posebnih zahtev za zdravila za gensko zdravljenje se za gensko spremenjene celice uporabljajo zahteve v zvezi s kakovostjo zdravil za somatsko celično zdravljenje in izdelke tkivnega inženirstva (glej oddelek 3.3).	For genetically modified cells, in addition to the specific requirements for gene therapy medicinal products, the quality requirements for somatic cell therapy medicinal products and tissue engineered products (see section 3.3) shall apply.
3.3 Posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva	3.3. Specific requirements for somatic cell therapy medicinal products and tissue engineered products
3.3.1 Uvod: končni izdelek, zdravilna učinkovina in vhodne snovi	3.3.1. Introduction: finished product, active substance and starting materials
Končno zdravilo vsebuje zdravilno učinkovino, ki je pripravljena v končnem stičnem vsebniku za predvideno zdravstveno uporabo in končni kombinaciji za kombinirana zdravila za napredno zdravljenje.	The finished medicinal product shall consist of the active substance formulated in its immediate container for the intended medical use, and in its final combination for combined advanced therapy medicinal products.
Zdravilna učinkovina je sestavljena iz gojenih celic in/ali tkiv.	The active substance shall be composed of the engineered cells and/or tissues.
Dodatne snovi (npr. ogrodja, matrice, pripomočki, biomateriali, biomolekule in/ali druge sestavine), ki se kombinirajo z manipuliranimi celicami, katerih sestavni del so, se obravnavajo kot vhodne snovi, čeprav njihov izvor ni biološki.	Additional substances (e.g. scaffolds, matrices, devices, biomaterials, biomolecules and/or other components) which are combined with manipulated cells of which they form an integral part shall be considered as starting materials, even if not of biological origin.
Materiali, ki se uporabljajo med izdelavo zdravilnih učinkovin (npr. mediji za gojenje, rastni faktorji) in za katere ni predvideno, da so del zdravilne učinkovine, se obravnavajo kot surovine.	Materials used during the manufacture of the active substance (e.g. culture media, growth factors) and that are not intended to form part of the active substance shall be considered as raw materials.
3.3.2 Posebne zahteve	3.3.2. Specific requirements
Poleg zahtev iz oddelkov 3.2.1 in 3.2.2 dela I te priloge se uporabljajo tudi naslednje zahteve:	In addition to the requirements set out in sections 3.2.1 and 3.2.2 of Part I of this Annex, the following requirements shall apply:
3.3.2.1 Vhodne snovi	3.3.2.1. Starting materials
(a)	(a)
V skladu z Direktivo 2004/23/ES se pripravi in predloži povzetek informacij o darovanju, preskrbi in preskušanju človeškega tkiva in celic, ki se uporabljajo kot vhodne novi. Če se kot vhodne snovi uporabljajo nezdrave celice ali tkiva (npr. rakasto tkivo), se njihova uporaba utemelji.	Summary information shall be provided on donation, procurement and testing of the human tissue and cells used as starting materials and made in accordance with Directive 2004/23/EC. If non-healthy cells or tissues (e.g. cancer tissue) are used as starting materials, their use shall be justified.
(b)	(b)
Če se združujejo populacije alogenskih celic, se navedejo strategije združevanja in ukrepi za zagotovitev sledljivosti.	If allogeneic cell populations are being pooled, the pooling strategies and measures to ensure traceability shall be described.
(c)	(c)
Morebitna variabilnost, vnesena prek človeških ali živalskih tkiv in celic, se obravnava kot del validacije postopka izdelave, opisa lastnosti zdravilne učinkovine in končnega izdelka, razvoja preskusov določanja vsebnosti, določanja specifikacij in stabilnosti.	The potential variability introduced through the human or animal tissues and cells shall be addressed as part of the validation of the manufacturing process, characterisation of the active substance and the finished product, development of assays, setting of specifications and stability.
(d)	(d)
Za izdelke, ki temeljijo na ksenogenskih celicah, se predložijo informacije o izvoru živali (kot so geografsko poreklo, reja živali, starost), posebnih merilih sprejemljivosti, ukrepih za preprečevanje in spremljanje okužb pri viru/živalih donatorkah, ter preskušanju živali na povzročitelje okužb, vključno z vertikalno prenosljivimi mikoorganizmi in virusi, ter dokazilo o primernosti objektov za živali.	For xenogeneic cell-based products, information on the source of animals (such as geographical origin, animal husbandry, age), specific acceptance criteria, measures to prevent and monitor infections in the source/donor animals, testing of the animals for infectious agents, including vertically transmitted micro-organisms and viruses, and evidence of the suitability of the animal facilities shall be provided.
(e)	(e)
Za izdelke, ki temeljijo na celicah in se pridobijo iz gensko spremenjenih živali, se navedejo posebne lastnosti celic, povezane z gensko spremembo. Predloži se podroben opis metode nastanka transgene živali in opis njenih lastnosti.	For cell-based products derived from genetically modified animals, the specific characteristics of the cells related to the genetic modification shall be described. A detailed description of the method of creation and the characterisation of the transgenic animal shall be provided.
(f)	(f)
Za gensko spremembo celic se uporabljajo tehnične zahteve iz oddelka 3.2.	For the genetic modification of the cells, the technical requirements specified in section 3.2 shall apply.
(g)	(g)
Navede in utemelji se režim preskušanja vseh dodatnih snovi (ogrodij, matric, pripomočkov, biomaterialov, biomolekul ali drugih sestavin), ki se kombinirajo z inženirsko obravnavanimi celicami, katerih sestavni del so.	The testing regimen of any additional substance (scaffolds, matrices, devices, biomaterials, biomolecules or other components), which are combined with engineered cells of which they form an integral part, shall be described and justified.
(h)	(h)
Za ogrodja, matrice in pripomočke, ki so zajeti v opredelitvi medicinskega pripomočka ali aktivnega medicinskega pripomočka za vsaditev, se predložijo informacije, ki se v skladu z oddelkom 3.4 zahtevajo za oceno kombiniranih zdravil za napredno zdravljenje.	For scaffolds, matrices and devices that fall under the definition of a medical device or active implantable medical device, the information required under section 3.4 for the evaluation of the combined advanced therapy medicinal product shall be provided.
3.3.2.2 Postopek izdelave	3.3.2.2. Manufacturing process
(a)	(a)
Postopek izdelave se validira, da se zagotovijo konsistentnost serij in postopka, funkcijska neokrnjenost celic od izdelave in transporta do aplikacije ali dajanja ter ustrezna stopnja diferenciacije.	The manufacturing process shall be validated to ensure batch and process consistency, functional integrity of the cells throughout manufacturing and transport up to the moment of application or administration, and proper differentiation state.
(b)	(b)
Če so celice gojene neposredno v matrici, ogrodju ali pripomočku ali na njih, se predložijo informacije o validaciji postopka gojenja celic v zvezi z rastjo celic, funkcijo in neokrnjenostjo kombinacije.	If cells are grown directly inside or on a matrix, scaffold or device, information shall be provided on the validation of the cell culture process with respect to cell-growth, function and integrity of the combination.
3.3.2.3 Opis lastnosti in strategija nadzora	3.3.2.3. Characterisation and control strategy
(a)	(a)
Predložijo se ustrezne informacije v zvezi z opisom lastnosti celične populacije ali mešanice celic v smislu identitete, čistote (npr. naključnih mikrobnih agensov in celičnih kontaminantov), sposobnosti preživetja, učinkovitosti, kariologije, rakotvornosti in primernosti za predvideno medicinsko uporabo. Dokaže se genska stabilnost celic.	Relevant information shall be provided on the characterisation of the cell population or cell mixture in terms of identity, purity (e.g. adventitious microbial agents and cellular contaminants), viability, potency, karyology, tumourigenicity and suitability for the intended medicinal use. The genetic stability of the cells shall be demonstrated.
(b)	(b)
Predložijo se kvalitativne informacije in, če je mogoče, kvantitativne informacije o nečistotah, povezanih z izdelkom in postopkom, ter vseh materialih, ki so med izdelavo sposobni vnesti razpadne produkte. Utemelji se obseg določanja nečistot.	Qualitative and, where possible, quantitative information on product- and process-related impurities, as well as on any material capable of introducing degradation products during production, shall be provided. The extent of the determination of impurities shall be justified.
(c)	(c)
Če na zdravilni učinkovini ali končnem izdelku ni mogoče opraviti nekaterih preskusov za sproščanje, ampak je to mogoče le na ključnih intermediatih in/ali kot preskus med izdelavo, se to utemelji.	If certain release tests cannot be performed on the active substance or finished product, but only on key intermediates and/or as in-process testing, this shall be justified.
(d)	(d)
Kadar so biološko aktivne molekule (kot so rastni faktorji, citokini) prisotne kot sestavine izdelka na podlagi celic, se opredelijo njihov vpliv in medsebojno delovanje z drugimi sestavinami zdravilne učinkovine.	Where biologically active molecules (such as growth factors, cytokines) are present as components of the cell-based product, their impact and interaction with other components of the active substance shall be characterised.
(e)	(e)
Kadar je tridimenzionalna struktura del predvidene funkcije, so stopnja diferenciacije, strukturna in funkcijska organizacija celic ter, kadar je primerno, pripravljena zunajcelična matrica del opisa lastnosti teh izdelkov na podlagi celic. Kadar je potrebno, neklinične raziskave dopolnijo fizikalno-kemijski opis lastnosti.	Where a three-dimensional structure is part of the intended function, the differentiation state, structural and functional organisation of the cells and, where applicable, the extracellular matrix generated shall be part of the characterisation for these cell-based products. Where needed, non-clinical investigations shall complement the physicochemical characterisation.
3.3.2.4 Pomožne snovi	3.3.2.4. Excipients
Za pomožne snovi, uporabljene v zdravilih na podlagi celic ali tkiva (npr. sestavine transportnega gojišča), se uporabljajo zahteve za nove pomožne snovi iz dela I te priloge, razen če obstajajo podatki o medsebojnem delovanju celic ali tkiv in pomožnih snovi.	For excipient(s) used in cell or tissue-based medicinal products (e.g. the components of the transport medium), the requirements for novel excipients, as laid down in Part I of this Annex, shall apply, unless data exists on the interactions between the cells or tissues and the excipients.
3.3.2.5 Razvojne študije	3.3.2.5. Developmental studies
Opis razvojnega programa obravnava izbiro materialov in postopkov. Obravnava se zlasti neokrnjenost celične populacije, kakršna je v končni sestavi.	The description of the development program shall address the choice of materials and processes. In particular, the integrity of the cell population as in the final formulation shall be discussed.
3.3.2.6 Referenčni materiali	3.3.2.6. Reference materials
Dokumentirajo in opredelijo se referenčni standardi, pomembni in značilni za zdravilne učinkovine in/ali končni izdelek.	A reference standard, relevant and specific for the active substance and/or the finished product, shall be documented and characterised.
3.4 Posebne zahteve za zdravila za napredno zdravljenje, ki vključujejo pripomočke	3.4. Specific requirements for advanced therapy medicinal products containing devices
3.4.1 Zdravila za napredno zdravljenje, ki vključujejo pripomočke, kot so opredeljeni v členu 7 Uredbe (ES) št. 1394/2007	3.4.1. Advanced therapy medicinal product containing devices as referred to in Article 7 of Regulation (EC) No 1394/2007
Predloži se opis fizikalnih lastnosti in učinkovitosti izdelka ter metod načrtovanja izdelka.	A description of the physical characteristics and performance of the product and a description of the product design methods shall be provided.
Opišeta se medsebojno delovanje in združljivost genov, celic in/ali tkiv ter strukturnih sestavin.	The interaction and compatibility between genes, cells and/or tissues and the structural components shall be described.
3.4.2 Kombinirana zdravila za napredno zdravljenje, kot so opredeljena v členu 2(1)(d) Uredbe (ES) št. 1394/2007	3.4.2. Combined advanced therapy medicinal products as defined in Article 2(1)(d) of Regulation (EC) No 1394/2007
Za celični ali tkivni del kombiniranega zdravila za napredno zdravljenje se uporabljajo posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva iz oddelka 3.3, v primeru gensko spremenjenih celic pa se uporabljajo posebne zahteve za zdravila za gensko zdravljenje iz oddelka 3.2.	For the cellular or tissue part of the combined advanced therapy medicinal product, the specific requirements for somatic cell therapy medicinal products and tissue engineered products set out in section 3.3 shall apply and, in the case of genetically modified cells, the specific requirements for gene therapy medicinal products set out in section 3.2 shall apply.
Medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev je lahko sestavni del zdravilne učinkovine. Kadar je medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev med izdelavo, aplikacijo ali dajanjem končnega izdelka kombiniran s celicami, se te štejejo kot sestavni del končnega izdelka.	The medical device or the active implantable medical device may be an integral part of the active substance. Where the medical device or active implantable medical device is combined with the cells at the time of the manufacture or application or administration of the finished products, they shall be considered as an integral part of the finished product.
Predložijo se informacije o medicinskem pripomočku ali aktivnem medicinskem pripomočku za vsaditev (ki je sestavni del zdravilne učinkovine ali končnega izdelka), pomembne za oceno kombiniranega zdravila za napredno zdravljenje. Te informacije vključujejo:	Information related to the medical device or the active implantable medical device (which is an integral part of the active substance or of the finished product) which is relevant for the evaluation of the combined advanced therapy medicinal product shall be provided. This information shall include:
(a)	(a)
informacije o izbiri in predvideni funkciji medicinskega pripomočka ali medicinskega pripomočka za vsaditev ter dokaz združljivosti pripomočka z drugimi sestavinami izdelka;	information on the choice and intended function of the medical device or implantable medical device and demonstration of compatibility of the device with other components of the product;
(b)	(b)
dokazilo o skladnosti dela medicinskega pripomočka z bistvenimi zahtevami iz Priloge I k Direktivi Sveta 93/42/EGS ( 31 ) ali dokazilo o skladnosti dela aktivnega pripomočka z bistvenimi zahtevami iz Priloge 1 k Direktivi Sveta 90/385/EGS ( 32 );	evidence of conformity of the medical device part with the essential requirements laid down in Annex I to Council Directive 93/42/EEC ( 31 ), or of conformity of the active implantable device part with the essential requirements laid down in Annex 1 to Council Directive 90/385/EEC ( 32 );
(c)	(c)
kadar je primerno, dokazilo o skladnosti medicinskega pripomočka ali medicinskega pripomočka za vsaditev z zahtevami glede BSE/TSE iz Direktive Komisije 2003/32/ES ( 33 );	where applicable, evidence of compliance of the medical device or implantable medical device with the BSE/TSE requirements laid down in Commission Directive 2003/32/EC ( 33 );
(d)	(d)
kadar so dostopni, rezultate vseh ocen dela medicinskega pripomočka ali dela aktivnega medicinskega pripomočka za vsaditev, ki jih je v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS izvedel priglašeni organ.	where available, the results of any assessment of the medical device part or the active implantable medical device part by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC.
Priglašeni organ, ki je izvedel oceno iz točke (d) tega oddelka, zagotovi na zahtevo organa, ki je pristojen za oceno vloge, vse informacije v zvezi z rezultati ocene v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS. To so lahko informacije in dokumenti iz zadevnih vlog v zvezi z oceno skladnosti, kadar je to potrebno za vrednotenje kombiniranega zdravila za napredno zdravljenje kot celoto.	The notified body which has carried out the assessment referred to in point (d) of this section shall make available on request of the competent authority assessing the application, any information related to the results of the assessment in accordance with Directive 93/42/EEC or Directive 90/385/EEC. This may include information and documents contained in the conformity assessment application concerned, where necessary for the evaluation of the combined advanced therapy medicinal product as a whole.
4. POSEBNE ZAHTEVE V ZVEZI Z MODULOM 4	4. SPECIFIC REQUIREMENTS REGARDING MODULE 4
4.1 Posebne zahteve za vsa zdravila za napredno zdravljenje	4.1. Specific requirements for all advanced therapy medicinal products
Zahteve iz dela I, modula 4, te priloge o farmakološkem in toksikološkem preskušanju zdravil niso vedno primerne zaradi edinstvenih ter raznolikih strukturnih in bioloških lastnosti zdravil za napredno zdravljenje. Tehnične zahteve v oddelkih 4.1, 4.2 in 4.3 pojasnjujejo, kako se zahteve iz dela I te priloge uporabljajo za zdravila za napredno zdravljenje. Kadar je bilo ustrezno, so bile ob upoštevanju posebnosti zdravil za napredno zdravljenje določene dodatne zahteve.	The requirements of Part I, Module 4 of this Annex on the pharmacological and toxicological testing of medicinal products may not always be appropriate due to unique and diverse structural and biological properties of advanced therapy medicinal products. The technical requirements in sections 4.1, 4.2 and 4.3 below explain how the requirements in Part I of this Annex apply to advanced therapy medicinal products. Where appropriate and taking into account the specificities of advanced therapy medicinal products, additional requirements have been set.
Utemeljitev nekliničnega razvoja ter meril za izbor ustreznih vrst in modelov (in vitro ter in vivo) se obravnava in obrazloži v nekliničnem pregledu. Izbrani živalski modeli lahko vključujejo imunsko ogrožene živali, živali z izbitim genom, živali s človeškimi lastnostmi in transgene živali. Upošteva se uporaba homolognih modelov (npr. mišje celice, analizirane v miših) ali modelov, ki posnemajo bolezni, zlasti za študije imunogenosti in imunotoksičnosti.	The rationale for the non-clinical development and the criteria used to choose the relevant species and models (in vitro and in vivo) shall be discussed and justified in the non-clinical overview. The chosen animal model(s) may include immuno-compromised, knockout, humanised or transgenic animals. The use of homologous models (e.g. mouse cells analysed in mice) or disease mimicking models shall be considered, especially for immunogenicity and immunotoxicity studies.
Poleg zahtev iz dela I se navedejo varnost, primernost in biološka združljivost vseh strukturnih sestavin (kot so matrice, ogrodja in pripomočki) ter vse dodatne snovi (kot so celični izdelki, biomolekule, biomateriali in kemične snovi), ki so prisotne v končnem izdelku. Upoštevajo se njihove fizikalne, mehanske, kemične in biološke lastnosti.	In addition to the requirements of Part I, the safety, suitability and biocompatibility of all structural components (such as matrices, scaffolds and devices) and any additional substances (such as cellular products, biomolecules, biomaterials, and chemical substances), which are present in the finished product, shall be provided. Their physical, mechanical, chemical and biological properties shall be taken into account.
4.2 Posebne zahteve za zdravila za gensko zdravljenje	4.2. Specific requirements for gene therapy medicinal products
Za določitev obsega in vrste nekliničnih študij, potrebnih za določitev ustrezne ravni nekliničnih podatkov o varnosti, se upoštevata oblika in vrsta zdravila za gensko zdravljenje.	In order to determine the extent and type of non-clinical studies necessary to determine the appropriate level of non-clinical safety data, the design and type of the gene therapy medicinal product shall be taken into account.
4.2.1 Farmakologija	4.2.1. Pharmacology
(a)	(a)
Študije učinkov in vitro ter in vivo v zvezi s predlagano terapevtsko uporabo (tj. farmakodinamične študije za „potrditev koncepta“) se predložijo z uporabo modelov in ustreznih živalskih vrst, ki so načrtovani za dokaz, da zaporedje nukleinskih kislin doseže predvideni cilj (ciljni organ ali celice) in opravlja predvideno funkcijo (raven izražanja in funkcionalno delovanje). V kliničnih študijah se navedeta trajanje funkcije zaporedja nukleinskih kislin in predlagan režim odmerjanja.	In vitro and in vivo studies of actions relating to the proposed therapeutic use (i.e. pharmacodynamic ‘proof of concept’ studies) shall be provided using models and relevant animal species designed to show that the nucleic acid sequence reaches its intended target (target organ or cells) and provides its intended function (level of expression and functional activity). The duration of the nucleic acid sequence function and the proposed dosing regimen in the clinical studies shall be provided.
(b)	(b)
Selektivnost cilja: kadar je predvideno, da ima zdravilo za gensko zdravljenje selektivno funkcionalnost ali funkcionalnost, omejeno s ciljem, se predložijo študije, ki potrjujejo posebnost in trajanje funkcionalnosti ter delovanja v ciljnih celicah in tkivih.	Target selectivity: When the gene therapy medicinal product is intended to have a selective or target-restricted functionality, studies to confirm the specificity and duration of functionality and activity in target cells and tissues shall be provided.
4.2.2 Farmakokinetika	4.2.2. Pharmacokinetics
(a)	(a)
Študije o biološki porazdelitvi vključujejo raziskave o obstojnosti, očistku in mobilizaciji. Študije o biološki porazdelitvi poleg tega obravnavajo tudi tveganje za prenos na zarodno linijo.	Biodistribution studies shall include investigations on persistence, clearance and mobilisation. Biodistribution studies shall additionally address the risk of germline transmission.
(b)	(b)
Glede na vrsto zadevnega izdelka se v oceni tveganja za okolje navedejo raziskave vnosa in tveganja za prenos tretjim stranem, razen če vloga vsebuje temeljito utemeljitev.	Investigations of shedding and risk of transmission to third parties shall be provided with the environmental risk assessment, unless otherwise duly justified in the application on the basis of the type of product concerned.
4.2.3 Toksikologija	4.2.3. Toxicology
(a)	(a)
Oceni se toksičnost končnega zdravila za gensko zdravljenje. Poleg tega se glede na vrsto izdelka upošteva posamezno preskušanje zdravilnih učinkovin in pomožnih snovi, pri čemer se ovrednoti in vivo učinek izdelkov, povezanih z izraženim zaporedjem nukleinskih kislin, ki niso predvideni za fiziološko funkcijo.	Toxicity of the finished gene therapy medicinal product shall be assessed. In addition, depending on the type of product, individual testing of active substance and excipients shall be taken into consideration, the in vivo effect of expressed nucleic acid sequence-related products which are not intended for the physiological function shall be evaluated.
(b)	(b)
Študije o toksičnosti enkratnega odmerka se lahko združijo s študijami o farmakologiji varnosti in farmakokinetiki, npr. za raziskovanje obstojnosti.	Single-dose toxicity studies may be combined with safety pharmacology and pharmacokinetic studies, e.g. to investigate persistence.
(c)	(c)
Študije o toksičnosti ponavljajočih odmerkov se predložijo, kadar se predvideva večkratno odmerjanje za človeka. Način in načrt uporabe jasno izražata načrtovano klinično odmerjanje. Kadar je lahko posledica enkratnega odmerjanja podaljšana funkcionalnost zaporedja nukleinskih kislin pri ljudeh, se upoštevajo študije o toksičnosti ponavljajočih odmerkov. Študije lahko trajajo dlje od običajnih študij o toksičnosti, kar je odvisno od obstojnosti zdravil za gensko zdravljenje in pričakovanih morebitnih tveganj. Navede se utemeljitev trajanja.	Repeated dose toxicity studies shall be provided when multiple dosing of human subjects is intended. The mode and scheme of administration shall closely reflect the planned clinical dosing. For those cases where single dosing may result in prolonged functionality of the nucleic acid sequence in humans, repeated toxicity studies shall be considered. The duration of the studies may be longer than in standard toxicity studies depending on the persistence of the gene therapy medicinal product and the anticipated potential risks. A justification for the duration shall be provided.
(d)	(d)
Prouči se genotoksičnost. Vendar se običajne študije o genotoksičnosti izvedejo le, kadar so potrebne za preskušanje posebne nečistote ali sestavine prenosnega sistema.	Genotoxicity shall be studied. However, standard genotoxicity studies shall only be conducted when they are necessary for testing a specific impurity or a component of the delivery system.
(e)	(e)
Prouči se rakotvornost. Običajne študije o rakotvornosti v življenjskem obdobju glodavcev niso potrebne. Vendar se glede na vrsto izdelka na primernih modelih in vivo/in vitro ovrednotijo možnosti za nastanek tumorjev.	Carcinogenicity shall be studied. Standard lifetime rodent carcinogenicity studies shall not be required. However, depending on the type of product, the tumourigenic potential shall be evaluated in relevant in vivo/in vitro models.
(f)	(f)
Reproduktivna in razvojna toksičnost: predložijo se študije o učinkih na plodnost in splošno reproduktivno funkcijo. Glede na vrsto zadevnega izdelka se predložijo študije o toksičnosti za zarodek in plod ter obporodni toksičnosti ter študije o prenosu zarodne linije, razen če vloga vsebuje temeljito utemeljitev.	Reproductive and developmental toxicity: Studies on the effects on fertility and general reproductive function shall be provided. Embryo-foetal and perinatal toxicity studies and germline transmission studies shall be provided, unless otherwise duly justified in the application on the basis of the type of product concerned.
(g)	(g)
Dodatne študije o toksičnosti	Additional toxicity studies
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Študije o združevanju: študije o združevanju se predložijo za vsa zdravila za gensko zdravljenje, razen če je pomanjkanje teh študij znanstveno utemeljeno, npr. ker zaporedje nukleinskih kislin ne bo vstopilo v celično jedro. Za zdravila za gensko zdravljenje, za katere se ne predvideva sposobnost združevanja, se izvedejo študije o združevanju, če kažejo podatki o biološki porazdelitvi tveganje za prenos zarodne linije.	Integration studies: integration studies shall be provided for any gene therapy medicinal product, unless the lack of these studies is scientifically justified, e.g. because nucleic acid sequences will not enter into the cell nucleus. For gene therapy medicinal products not expected to be capable of integration, integration studies shall be performed, if biodistribution data indicate a risk for germline transmission.
—	—
Imunogenost in imunotoksičnost: proučijo se morebitni imunogenski in imunotoksični učinki.	Immunogenicity and immunotoxicity: potential immunogenic and immunotoxic effects shall be studied.
4.3 Posebne zahteve za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva	4.3. Specific requirements for somatic cell therapy medicinal products and tissue engineered products
4.3.1 Farmakologija	4.3.1. Pharmacology
(a)	(a)
Primarne farmakološke študije so zadostne, da dokažejo potrditev koncepta. Prouči se medsebojno delovanje izdelkov na podlagi celic, ki jih obdaja tkivo.	The primary pharmacological studies shall be adequate to demonstrate the proof of concept. The interaction of the cell-based products with the surrounding tissue shall be studied.
(b)	(b)
Določita se količina izdelka, ki je potrebna za doseganje želenega učinka/učinkovitega odmerka, in pogostost odmerjanja, kar je odvisno od vrste izdelka.	The amount of product needed to achieve the desired effect/the effective dose, and, depending on the type of product, the frequency of dosing shall be determined.
(c)	(c)
Sekundarne farmakološke študije se upoštevajo pri ovrednotenju morebitnih fizioloških učinkov, ki niso povezani z želenim zdravilnim učinkom zdravil za somatsko celično zdravljenje v obliki izdelkov tkivnega inženirstva ali dodatnih snovi, ker so lahko biološko zdravilne molekule poleg želenih beljakovin skrite ali ker lahko imajo želene beljakovine neželena ciljna območja.	Secondary pharmacological studies shall be taken into account to evaluate potential physiological effects that are not related to the desired therapeutic effect of the somatic cell therapy medicinal product, of the tissue engineered product or of additional substances, as biologically active molecules besides the protein(s) of interest might be secreted or the protein(s) of interest could have unwanted target sites.
4.3.2 Farmakokinetika	4.3.2. Pharmacokinetics
(a)	(a)
Običajne študije o farmakokinetiki za raziskovanje absorpcije, porazdelitve, presnove in izločanja niso potrebne. Vendar se glede na vrsto zadevnega izdelka raziščejo parametri, kot so sposobnost preživetja, dolgoživost, porazdelitev, rast, diferenciacija in migracija, razen če vloga vsebuje temeljito utemeljitev, da to ni potrebno.	Conventional pharmacokinetic studies to investigate absorption, distribution, metabolism and excretion shall not be required. However, parameters such as viability, longevity, distribution, growth, differentiation and migration shall be investigated, unless otherwise duly justified in the application on the basis of the type of product concerned.
(b)	(b)
Za zdravila za somatsko celično zdravljenje in izdelke tkivnega inženirstva, ki proizvajajo sistemsko zdravilne biomolekule, se proučijo porazdelitev, trajanje in količina izraženih molekul.	For somatic cell therapy medicinal products and tissue engineered products, producing systemically active biomolecules, the distribution, duration and amount of expression of these molecules shall be studied.
4.3.3 Toksikologija	4.3.3. Toxicology
(a)	(a)
Oceni se toksičnost končnega izdelka. Upošteva se posamezno preskušanje zdravilnih učinkovin, dodatnih snovi in vseh nečistot, povezanih s postopkom.	The toxicity of the finished product shall be assessed. Individual testing of active substance(s), excipients, additional substances and any process-related impurities shall be taken into consideration.
(b)	(b)
Opazovanja lahko trajajo dlje kot pri običajnih študijah o toksičnosti, pri čemer se upošteva pričakovana življenjska doba zdravila skupaj s farmakodinamičnimi in farmakokinetičnimi lastnostmi. Navede se utemeljitev trajanja.	The duration of observations may be longer than in standard toxicity studies and the anticipated lifespan of the medicinal product, together with its pharmacodynamic and pharmacokinetic profile, shall be taken into consideration. A justification of the duration shall be provided.
(c)	(c)
Običajne študije o rakotvornosti in genotoksičnosti niso potrebne, razen v zvezi z rakotvornim potencialom izdelka.	Conventional carcinogenicity and genotoxicity studies shall not be required, except with regard to the tumourigenic potential of the product.
(d)	(d)
Proučijo se imunogenski in imunotoksični učinki.	Potential immunogenic and immunotoxic effects shall be studied.
(e)	(e)
Če vsebujejo izdelki na podlagi celic živalske celice, se obravnavajo s tem povezani posamezni pomisleki glede varnosti, kot je prenos ksenogenskih patogenov na ljudi.	In the case of cell-based products containing animal cells, the associated specific safety concerns such as transmission to humans of xenogeneic pathogens shall be addressed.
5. POSEBNE ZAHTEVE V ZVEZI Z MODULOM 5	5. SPECIFIC REQUIREMENTS REGARDING MODULE 5
5.1 Posebne zahteve za vsa zdravila za napredno zdravljenje	5.1. Specific requirements for all advanced therapy medicinal products
5.1.1 \| Posebne zahteve v tem oddelku dela IV so dodatne zahteve poleg zahtev iz modula 5 v delu I te priloge.	5.1.1. \| The specific requirements in this section of Part IV are additional requirements to those set in Module 5 in Part I of this Annex.
5.1.2 \| Kadar je zaradi klinične uporabe zdravil za napredno zdravljenje potrebno posebno hkratno zdravljenje in kadar vključuje taka uporaba kirurške postopke, se razišče in opiše postopek zdravljenja kot celota. Predložijo se informacije o standardizaciji in optimizaciji teh postopkov med kliničnim razvojem. \| Kadar lahko medicinski pripomočki, ki se uporabljajo med kirurškim postopkom za aplikacijo, vsaditev ali dajanje zdravila za napredno zdravljenje, vplivajo na učinkovitost ali varnost izdelka za napredno zdravljenje, se predložijo informacije o teh pripomočkih. \| Določi se posebno strokovno znanje, ki se zahteva za aplikacijo, vsaditev, dajanje ali spremljevalne dejavnosti. Po potrebi se predloži načrt usposabljanja zdravstvenih delavcev za postopke uporabe, aplikacije, vsaditve ali dajanja teh izdelkov.	5.1.2. \| Where the clinical application of advanced therapy medicinal products requires specific concomitant therapy and involve surgical procedures, the therapeutic procedure as a whole shall be investigated and described. Information on the standardisation and optimisation of those procedures during clinical development shall be provided. \| Where medical devices used during the surgical procedures for application, implantation or administration of the advanced therapy medicinal product may have an impact on the efficacy or safety of the advanced therapy product, information on these devices shall be provided. \| Specific expertise required to carry out the application, implantation, administration or follow-up activities shall be defined. Where necessary, the training plan of health care professionals on the use, application, implantation or administration procedures of these products shall be provided.
5.1.3 \| Ker se lahko postopek izdelave zdravil za napredno zdravljenje zaradi njihovih lastnosti med kliničnim razvojem spremeni, se lahko zahtevajo dodatne študije za dokaz primerljivosti.	5.1.3. \| Given that, due to the nature of advanced therapy medicinal products, their manufacturing process may change during clinical development, additional studies to demonstrate comparability may be required.
5.1.4 \| Med kliničnim razvojem se obravnavajo tveganja, ki so povezana z morebitnimi povzročitelji okužb ali uporabo materiala, pridobljenega iz živalskih virov, in ukrepi za zmanjšanje takšnega tveganja.	5.1.4. \| During clinical development, risks arising from potential infectious agents or the use of material derived from animal sources and measures taken to reduce such risk shall be addressed.
5.1.5 \| Izbira odmerka in časovni razpored uporabe se opredelita s študijami za ugotavljanje odmerkov.	5.1.5. \| Dose selection and schedule of use shall be defined by dose-finding studies.
5.1.6 \| Učinkovitost predlaganih indikacij se podpre z ustreznimi rezultati kliničnih študij, ki uporabljajo klinično smiselne končne točke za predvideno uporabo. V nekaterih kliničnih pogojih je lahko potrebno dokazilo o dolgoročni učinkovitosti. Zagotovi se strategija za ovrednotenje dolgoročne učinkovitosti.	5.1.6. \| The efficacy of the proposed indications shall be supported by relevant results from clinical studies using clinically meaningful endpoints for the intended use. In certain clinical conditions, evidence of long-term efficacy may be required. The strategy to evaluate long-term efficacy shall be provided.
5.1.7 \| Strategija za dolgoročno spremljanje varnosti in učinkovitosti se vključi v načrt za obvladovanje tveganja.	5.1.7. \| A strategy for the long-term follow-up of safety and efficacy shall be included in the risk management plan.
5.1.8 \| Za kombinirana zdravila za napredno zdravljenje se načrtujejo in izvedejo študije s kombiniranim izdelkom kot celoto.	5.1.8. \| For combined advanced therapy medicinal products, the safety and efficacy studies shall be designed for and performed on the combined product as a whole.
5.2 Posebne zahteve za zdravila za gensko zdravljenje	5.2. Specific requirements for gene therapy medicinal products
5.2.1 Študije o farmakokinetiki pri ljudeh	5.2.1. Human pharmacokinetic studies
Študije o farmakokinetiki pri ljudeh vključujejo naslednje vidike:	Human pharmacokinetic studies shall include the following aspects:
(a)	(a)
študije za obravnavanje izločanja zdravil za gensko zdravljenje;	shedding studies to address the excretion of the gene therapy medicinal products;
(b)	(b)
študije o biološki porazdelitvi;	biodistribution studies;
(c)	(c)
študije o farmakokinetiki zdravila in delih izražanja genov (npr. izražene beljakovine ali genomski podpisi).	pharmacokinetic studies of the medicinal product and the gene expression moieties (e.g. expressed proteins or genomic signatures).
5.2.2 Študije o farmakodinamiki pri ljudeh	5.2.2. Human pharmacodynamic studies
Študije o farmakodinamiki pri ljudeh obravnavajo izražanje in funkcijo zaporedja nukleinskih kislin po dajanju zdravil za gensko zdravljenje.	Human pharmacodynamic studies shall address the expression and function of the nucleic acid sequence following administration of the gene therapy medicinal product.
5.2.3 Študije o varnosti	5.2.3. Safety studies
Študije o varnosti obravnavajo naslednje vidike:	Safety studies shall address the following aspects:
(a)	(a)
nastanek vektorja, sposobnega za razmnoževanje;	emergence of replication competent vector;
(b)	(b)
nastanek novih sevov;	emergence of new strains;
(c)	(c)
preureditev sedanjih genomskih zaporedij;	reassortment of existing genomic sequences;
(d)	(d)
neoplastično širjenje zaradi insercijske mutagenosti.	neoplastic proliferation due to insertional mutagenicity.
5.3 Posebne zahteve za zdravila za somatsko celično zdravljenje	5.3. Specific requirements for somatic cell therapy medicinal products
5.3.1 Zdravila za somatsko celično zdravljenje, pri katerih temelji način delovanja na proizvodnji določenih aktivnih biomolekul	5.3.1. Somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s)
Za zdravila za somatsko celično zdravljenje, pri katerih temelji način delovanja na proizvodnji določenih aktivnih biomolekul, se obravnavajo farmakokinetične lastnosti (zlasti porazdelitev, trajanje in količina izražanja) teh molekul, če je to izvedljivo.	For somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s), the pharmacokinetic profile (in particular distribution, duration and amount of expression) of those molecules shall be addressed, if feasible.
5.3.2 Biološka porazdelitev, obstojnost in dolgoročna vsaditev sestavin zdravil za somatsko celično zdravljenje	5.3.2. Biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components
Med kliničnim razvojem se obravnavajo biološka porazdelitev, obstojnost in dolgoročna vsaditev sestavin zdravila za somatsko celično zdravljenje.	The biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components shall be addressed during the clinical development.
5.3.3 Študije o varnosti	5.3.3. Safety studies
Študije o varnosti obravnavajo:	Safety studies shall address the following aspects:
(a)	(a)
porazdelitev in vsaditev po dajanju zdravila;	distribution and engrafting following administration;
(b)	(b)
ektopično vsaditev;	ectopic engraftment;
(c)	(c)
onkogeno preoblikovanje in zanesljivost celičnih/tkivnih rodov.	oncogenic transformation and cell/tissue lineage fidelity.
5.4 Posebne zahteve za izdelke tkivnega inženirstva	5.4. Specific requirements for tissue engineered products
5.4.1 Študije o farmakokinetiki	5.4.1. Pharmacokinetic studies
Kadar običajne študije o farmakokinetiki niso pomembne za izdelke tkivnega inženirstva, se med kliničnim razvojem obravnavajo biološka porazdelitev, obstojnost in razgradnja sestavin izdelkov tkivnega inženirstva.	Where conventional pharmacokinetic studies are not relevant for tissue engineered products, the biodistribution, persistence and degradation of the tissue engineered product components shall be addressed during the clinical development.
5.4.2 Študije o farmakodinamiki	5.4.2. Pharmacodynamic studies
Študije o farmakodinamiki obravnavajo posebne lastnosti izdelkov tkivnega inženirstva, katerim so te študije tudi prilagojene. Predložita se dokazilo o „potrditvi koncepta“ in kinetičnost izdelka, da se doseže predvidena obnovitev, popravljanje ali nadomestitev. Upoštevajo se ustrezni farmakodinamični označevalci, povezani s predvidenimi funkcijami in strukturo.	Pharmacodynamic studies shall be designed and tailored to the specificities of tissue engineered products. The evidence for the ‘proof of concept’ and the kinetics of the product to obtain the intended regeneration, repairing or replacement shall be provided. Suitable pharmacodynamic markers, related to the intended function(s) and structure shall be taken into account.
5.4.3 Študije o varnosti	5.4.3. Safety studies
Uporablja se oddelek 5.3.3.	Section 5.3.3 shall apply.
▼B	▼B
PRILOGA II	ANNEX II
DEL A	PART A
Razveljavljene direktive z njihovimi zaporednimi spremembami (na katere se sklicuje člen 128)	Repealed Directives, with their successive amendments (referred to by Article 128)
Direktiva Sveta 65/65/EGS (UL 22, 9.2.1965, str. 369/65)	Council Directive 65/65/EEC (OJ 22, 9.2.1965, p. 369/65)
Direktiva Sveta 66/454/EGS (UL 144, 5.8.1966, str. 2658/66)	Council Directive 66/454/EEC (OJ 144, 5.8.1966, p. 2658/66)
Direktiva Sveta 75/319/EGS (UL L 147, 9.6.1975, str. 13)	Council Directive 75/319/EEC (OJ L 147, 9.6.1975, p. 13)
Direktiva Sveta 83/570/EGS (UL L 332, 28.11.1983, str. 1)	Council Directive 83/570/EEC (OJ L 332, 28.11.1983, p. 1)
Direktiva Sveta 87/21/EGS (UL L 15, 17.1.1987, str. 36)	Council Directive 87/21/EEC (OJ L 15, 17.1.1987, p. 36)
Direktiva Sveta 89/341/EGS (UL L 142, 25.5.1989, str. 11)	Council Directive 89/341/EEC (OJ L 142, 25.5.1989, p. 11)
Direktiva Sveta 92/27/EGS (UL L 113, 30.4.1992, str. 8)	Council Directive 92/27/EEC (OJ L 113, 30.4.1992, p. 8)
Direktiva Sveta 93/39/EGS (UL L 214, 24.8.1993, str. 22)	Council Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22)
Direktiva Sveta 75/318/EGS (UL L 147, 9.6.1975, str. 1)	Council Directive 75/318/EEC (OJ L 147, 9.6.1975, p. 1)
Direktiva Sveta 83/570/EGS	Council Directive 83/570/EEC
Direktiva Sveta 87/19/EGS (UL L 15, 17.1.1987, str. 31)	Council Directive 87/19/EEC (OJ L 15, 17.1.1987, p. 31)
Direktiva Sveta 89/341/EGS	Council Directive 89/341/EEC
Direktiva Komisije 91/507/EGS (UL L 270, 26.9.1991, str. 32)	Commission Directive 91/507/EEC (OJ L 270, 26.9.1991, p. 32)
Direktiva Sveta 93/39/EGS	Council Directive 93/39/EEC
Direktiva Komisije 1999/82/ES (UL L 243, 15.9.1999, str. 7)	Commission Directive 1999/82/EC (OJ L 243, 15.9.1999, p. 7)
Direktiva Komisije 1999/83/ES (UL L 243, 15.9.1999, str. 9)	Commission Directive 1999/83/EC (OJ L 243, 15.9.1999, p. 9)
Direktiva Sveta 75/319/EGS	Council Directive 75/319/EEC
Direktiva Sveta 78/420/EGS (UL L 123, 11.5.1978, str. 26)	Council Directive 78/420/EEC (OJ L 123, 11.5.1978, p. 26)
Direktiva Sveta 83/570/EGS	Council Directive 83/570/EEC
Direktiva Sveta 89/341/EGS	Council Directive 89/341/EEC
Direktiva Sveta 92/27/EGS	Council Directive 92/27/EEC
Direktiva Sveta 93/39/EGS	Council Directive 93/39/EEC
Direktiva Komisije 2000/38/ES (UL L 139, 10.6.2000, str. 28)	Commission Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28)
Direktiva Sveta 89/342/EGS (UL L 142, 25.5.1989, str. 14)	Council Directive 89/342/EEC (OJ L 142, 25.5.1989, p. 14)
Direktiva Sveta 89/343/EGS (UL L 142, 25.5.1989, str. 16)	Council Directive 89/343/EEC (OJ L 142, 25.5.1989, p. 16)
Direktiva Sveta 89/381/EGS (UL L 181, 28.6.1989, str. 44)	Council Directive 89/381/EEC (OJ L 181, 28.6.1989, p. 44)
Direktiva Sveta 92/25/EGS (UL L 113, 30.4.1992, str. 1)	Council Directive 92/25/EEC (OJ L 113, 30.4.1992, p. 1)
Direktiva Sveta 92/26/EGS (UL L 113, 30.4.1992, str. 5)	Council Directive 92/26/EEC (OJ L 113, 30.4.1992, p. 5)
Direktiva Sveta 92/27/EGS	Council Directive 92/27/EEC
Direktiva Sveta 92/28/EGS (UL L 113, 30.4.1992, str. 13)	Council Directive 92/28/EEC (OJ L 113, 30.4.1992, p. 13)
Direktiva Sveta 92/73/EGS (UL L 297, 13.10.1992, str. 8)	Council Directive 92/73/EEC (OJ L 297, 13.10.1992, p. 8)
DEL B	PART B
Roki za prenos v nacionalno zakonodajo (kot navedeno v členu 128)	Time-limits for transposition into national law (referred to by Article 128)
Direktiva \| Rok za prenos	Directive \| Deadline for transposition
Direktiva 65/65/EGS \| 31. december 1966	Directive 65/65/EEC \| 31 December 1966
Direktiva 66/454/EGS \| –	Directive 66/454/EEC \| —
Direktiva 75/318/EGS \| 21. november 1976	Directive 75/318/EEC \| 21 November 1976
Direktiva 75/319/EGS \| 21. november 1976	Directive 75/319/EEC \| 21 November 1976
Direktiva 78/420/EGS \| –	Directive 78/420/EEC \| —
Direktiva 83/570/EGS \| 31. oktober 1985	Directive 83/570/EEC \| 31 October 1985
Direktiva 87/19/EGS \| 1. julij 1987	Directive 87/19/EEC \| 1 July 1987
Direktiva 87/21/EGS \| 1. julij 1987 \| 1. januar 1992 (1)	Directive 87/21/EEC \| 1 July 1987 \| 1 January 1992 (1)
Direktiva 89/341/EGS \| 1. januar 1992	Directive 89/341/EEC \| 1 January 1992
Direktiva 89/342/EGS \| 1. januar 1992	Directive 89/342/EEC \| 1 January 1992
Direktiva 89/343/EGS \| 1. januar 1992	Directive 89/343/EEC \| 1 January 1992
Direktiva 89/381/EGS \| 1. januar 1992	Directive 89/381/EEC \| 1 January 1992
Direktiva 91/507/EGS \| 1. januar 1992 (2) \| 1. januar 1995 (3)	Directive 91/507/EEC \| 1 January 1992 (2) \| 1 January 1995 (3)
Direktiva 92/25/EGS \| 1. januar 1993	Directive 92/25/EEC \| 1 January 1993
Direktiva 92/26/EGS \| 1. januar 1993	Directive 92/26/EEC \| 1 January 1993
Direktiva 92/27/EGS \| 1. januar 1993	Directive 92/27/EEC \| 1 January 1993
Direktiva 92/28/EGS \| 1. januar 1993	Directive 92/28/EEC \| 1 January 1993
Direktiva 92/73/EGS \| 31. december 1993	Directive 92/73/EEC \| 31 December 1993
Direktiva 93/39/EGS \| 1. januar 1995 (4) \| 1. januar 1998 (5)	Directive 93/39/EEC \| 1 January 1995 (4) \| 1 January 1998 (5)
Direktiva 1999/82/ES \| 1. januar 2000	Directive 1999/82/EC \| 1 January 2000
Direktiva 1999/83/ES \| 1. marec 2000	Directive 1999/83/EC \| 1 March 2000
Direktiva 2000/38/ES \| 5. december 2001	Directive 2000/38/EC \| 5 December 2001
(1) \| Rok za prenos, ki se uporablja za Grčijo, Španijo in Portugalsko. \| (2) \| Razen točke 3.3 oddelka A v delu II priloge. \| (3) \| Rok za prenos, ki se uporablja za točko 3.3 oddelka A v delu II Priloge. \| (4) \| Razen glede na člen 1(6). \| (5) \| Rok za prenos, ki se uporablja za člen 1(7).	(1) \| Deadline for transposition applicable to Greece, Spain and Portugal. \| (2) \| Except Section A, point 3.3 in Part II of the Annex. \| (3) \| Deadline for transposition applicable to Section A, point 3.3 in Part II of the Annex. \| (4) \| Except with regard to Article 1(6). \| (5) \| Deadline for transposition applicable to Article 1(7).
PRILOGA III	ANNEX III
KORELACIJSKA PREGLEDNICA	CORRELATION TABLE
Ta direktiva \| 65/65/EGS \| 75/318/EGS \| 75/319/EGS \| 89/342/EGS \| 89/343/EGS \| 89/381/EGS \| 92/25/EGS \| 92/26/EGS \| 92/27/EGS \| 92/28/EGS \| 92/73/EGS	This Dir. \| 65/65/EEC \| 75/318/EEC \| 75/319/EEC \| 89/342/EEC \| 89/343/EEC \| 89/381/EEC \| 92/25/EEC \| 92/26/EEC \| 92/27/EEC \| 92/28/EEC \| 92/73/EEC
Člen 1(1) do (3) \| Člen 1(1) do (3) \| \| \| \| \| \| \| \| \| \|	Art. 1(1) to (3) \| Art. 1(1) to (3) \| \| \| \| \| \| \| \| \| \|
Člen 1(4) \| \| \| Priloga \| Člen 1(1) in (2) \| \| \| \| \| \| \|	Art. 1(4) \| \| \| Annex \| Art. 1(1) and (2) \| \| \| \| \| \| \|
Člen 1(5) \| \| \| \| \| \| \| \| \| \| \| Člen 1	Art. 1(5) \| \| \| \| \| \| \| \| \| \| \| Art. 1
Člen 1(6) do (9) \| \| \| \| \| Člen 1(2) \| \| \| \| \| \|	Art. 1(6) to (9) \| \| \| \| \| Art. 1(2) \| \| \| \| \| \|
Člen 1(10) \| \| \| \| \| \| Člen 1(1) \| \| \| \| \|	Art. 1(10) \| \| \| \| \| \| Art. 1(1) \| \| \| \| \|
Člen 1(11) do (16) \| \| \| Člen 29b, prvi odstavek \| \| \| \| \| \| \| \|	Art. 1(11) to (16) \| \| \| Art. 29b, 1st paragraph \| \| \| \| \| \| \| \|
Člen 1(17) in (18) \| \| \| \| \| \| \| Člen 1(2) \| \| \| \|	Art. 1(17) and (18) \| \| \| \| \| \| \| Art. 1(2) \| \| \| \|
Člen 1(19) \| \| \| \| \| \| \| \| Člen 1(2), drugi stavek \| \| \|	Art. 1(19) \| \| \| \| \| \| \| \| Art. 1(2), 2nd sentence \| \| \|
Člen 1(20) do (26) \| \| \| \| \| \| \| \| \| Člen 1(2) \| \|	Art. 1(20) to (26) \| \| \| \| \| \| \| \| \| Art. 1(2) \| \|
Člen 1(27) \| \| \| Člen 8(1) \| \| \| \| \| \| \| \|	Art. 1(27) \| \| \| Art. 8(1) \| \| \| \| \| \| \| \|
Člen 1(28) \| \| \| Člen 10(1) \| \| \| \| \| \| \| \|	Art. 1(28) \| \| \| Art. 10(1) \| \| \| \| \| \| \| \|
Člen 2 \| Člen 2(1) \| \| \| \| \| \| \| \| \| \|	Art. 2 \| Art. 2(1) \| \| \| \| \| \| \| \| \| \|
Člen 3(1) in (2) \| Člen 1(4) in (5) \| Člen 2(3), prva alinea \| \| \| \| \| \| \| \| \| \|	Art. 3(1) and (2) \| Art. 1(4) and (5) \| Art 2(3), 1st indent \| \| \| \| \| \| \| \| \| \|
Člen 3(3) in (4) \| Člen 2(3), druga in tretja alinea \| \| \| \| \| \| \| \| \| \|	Art. 3(3) and (4) \| Art.2(3), 2nd and 3rd indents \| \| \| \| \| \| \| \| \| \|
Člen 3(5) \| \| \| \| \| Člen 1(1) \| \| \| \| \| \|	Art. 3(5) \| \| \| \| \| Art. 1(1) \| \| \| \| \| \|
Člen 3(6) \| \| \| \| \| \| Člen 1(2) \| \| \| \| \|	Art. 3(6) \| \| \| \| \| \| Art. 1(2) \| \| \| \| \|
Člen 4(1) \| \| \| \| \| Člen 1(3) \| \| \| \| \| \|	Art. 4(1) \| \| \| \| \| Art. 1(3) \| \| \| \| \| \|
Člen 4(2) \| \| \| \| \| \| Člen 1(3) \| \| \| \| \|	Art. 4(2) \| \| \| \| \| \| Art. 1(3) \| \| \| \| \|
Člen 4(3) \| Člen 3, drugi pododstavek \| \| \| \| \| \| \| \| \| \|	Art. 4(3) \| Art. 3, 2nd subparagraph \| \| \| \| \| \| \| \| \| \|
Člen 4(4) \| Člen 6 \| \| \| \| \| \| \| \| \| \|	Art. 4(4) \| Art. 6 \| \| \| \| \| \| \| \| \| \|
Člen 5 \| Člen 2(4) \| \| \| \| \| \| \| \| \| \|	Art. 5 \| Art. 2(4) \| \| \| \| \| \| \| \| \| \|
Člen 6(1) \| Člen 3(1) \| \| \| \| \| \| \| \| \| \|	Art. 6(1) \| Art. 3(1) \| \| \| \| \| \| \| \| \| \|
Člen 6(2) \| \| \| \| \| Člen 2, prvi stavek \| \| \| \| \| \|	Art. 6(2) \| \| \| \| \| Art. 2, 1st sentence \| \| \| \| \| \|
Člen 7 \| \| \| \| \| Člen 2, drugi stavek \| \| \| \| \| \|	Art. 7 \| \| \| \| \| Art. 2, 2nd sentence \| \| \| \| \| \|
Člen 8(1) in (2) \| Člen 4(1) in (2) \| \| \| \| \| \| \| \| \| \|	Art. 8(1) and (2) \| Art. 4(1) and (2) \| \| \| \| \| \| \| \| \| \|
Člen 8(3)(a) do (e) \| Člen 4, tretji odst., točke 1 do 5 \| Člen 1, prvi odstavek \| \| \| \| \| \| \| \| \|	Art. 8(3)(a) to (e) \| Art. 4, 3rd para., points 1 to 5 \| Art. 1, 1st paragraph \| \| \| \| \| \| \| \| \|
Člen 8(3)(f) do (i) \| Člen 4, tretji odstavek, točke 6 do 8.1 \| \| \| \| \| \| \| \| \| \|	Art. 8(3)(f) to (i) \| Art. 4, 3rd para., points 6 to 8.1 \| \| \| \| \| \| \| \| \| \|
Člen 8(3)(j) do (l) \| Člen 4, tretji odst., točke 9 do 11 \| \| \| \| \| \| \| \| \| \|	Art. 8(3)(j) to (l) \| Art. 4, 3rd para., points 9 to 11 \| \| \| \| \| \| \| \| \| \|
Člen 9 \| \| \| \| \| Člen 3 \| \| \| \| \| \|	Art. 9 \| \| \| \| \| Art. 3 \| \| \| \| \| \|
Člen 10(1) \| Člen 4, tretji odstavek, točka 8.2 \| \| \| \| \| \| \| \| \| \|	Art. 10(1) \| Art. 4, 3rd paragraph, point 8.2 \| \| \| \| \| \| \| \| \| \|
Člen 10(2) \| \| Člen 1, drugi odstavek \| \| \| \| \| \| \| \| \|	Art. 10(2) \| \| Art. 1, 2nd paragraph \| \| \| \| \| \| \| \| \|
Člen 11, točke 1 do 5.3 \| Člen 4a, točke 1 do 5.3 \| \| \| \| \| \| \| \| \| \|	Art. 11, points 1 to 5.3 \| Art. 4a, points 1 to 5.3 \| \| \| \| \| \| \| \| \| \|
Člen 11, točka 5.4 \| Člen 4a, točka 5.4 \| \| \| Člen 3 \| \| \| \| \| \| \|	Art. 11, point 5.4 \| Art. 4a, point 5.4 \| \| \| Art. 3 \| \| \| \| \| \| \|
Člen 11, točke 5.5 do 6.4 \| Člen 4a, točke 5.5 do 6.4 \| \| \| \| \| \| \| \| \| \|	Art. 11, points 5.5 to 6.4 \| Art. 4a, points 5.5 to 6.4 \| \| \| \| \| \| \| \| \| \|
Člen 11, točka 6.5 \| Člen 4a, točka 6.6 \| \| \| \| \| \| \| \| \| \|	Art. 11, point 6.5 \| Art. 4a, point 6.6 \| \| \| \| \| \| \| \| \| \|
Člen 11, točka 7 \| Člen 4a, točka 6.5 \| \| \| \| \| \| \| \| \| \|	Art. 11, point 7 \| Art. 4a, point 6.5 \| \| \| \| \| \| \| \| \| \|
Člen 11, točke 8 do 9 \| \| \| \| \| Člen 4 \| \| \| \| \| \|	Art. 11, points 8 to 9 \| \| \| \| \| Art. 4 \| \| \| \| \| \|
Člen 12(1) \| \| \| Člen 1 \| \| \| \| \| \| \| \|	Art. 12(1) \| \| \| Art. 1 \| \| \| \| \| \| \| \|
Člen 12(2) in (3) \| \| \| Člen 2 \| \| \| \| \| \| \| \|	Art. 12(2) and (3) \| \| \| Art. 2 \| \| \| \| \| \| \| \|
Člen 13 \| \| \| \| \| \| \| \| \| \| \| Člen 6(1) in (2)	Art. 13 \| \| \| \| \| \| \| \| \| \| \| Art. 6(1) and (2)
Člen 14(1) in (2) \| \| \| \| \| \| \| \| \| \| \| Člen 7(1) in (4)	Art. 14(1) and (2) \| \| \| \| \| \| \| \| \| \| \| Art. 7(1) and (4)
Člen 14(3) \| \| \| \| \| \| \| \| \| \| \| Člen 4, drugi odstavek	Art. 14(3) \| \| \| \| \| \| \| \| \| \| \| Art. 4, 2nd paragraph
Člen 15 \| \| \| \| \| \| \| \| \| \| \| Člen 8	Art. 15 \| \| \| \| \| \| \| \| \| \| \| Art. 8
Člen 16 \| \| \| \| \| \| \| \| \| \| \| Člen 9	Art. 16 \| \| \| \| \| \| \| \| \| \| \| Art. 9
Člen 17 \| Člen 7 \| \| \| \| \| \| \| \| \| \|	Art. 17 \| Art. 7 \| \| \| \| \| \| \| \| \| \|
Člen 18 \| Člen 7a \| \| \| \| \| \| \| \| \| \|	Art. 18 \| Art. 7a \| \| \| \| \| \| \| \| \| \|
Člen 19 \| \| \| Člen 4 \| \| \| \| \| \| \| \|	Art. 19 \| \| \| Art. 4 \| \| \| \| \| \| \| \|
Člen 20 \| \| \| Člen 5 \| \| \| \| \| \| \| \|	Art. 20 \| \| \| Art. 5 \| \| \| \| \| \| \| \|
Člen 21 \| Člen 4b \| \| \| \| \| \| \| \| \| \|	Art. 21 \| Art. 4b \| \| \| \| \| \| \| \| \| \|
Člen 22 \| Člen 10(2) \| \| \| \| \| \| \| \| \| \|	Art. 22 \| Art. 10(2) \| \| \| \| \| \| \| \| \| \|
Člen 23 \| Člen 9a \| \| \| \| \| \| \| \| \| \|	Art. 23 \| Art. 9a \| \| \| \| \| \| \| \| \| \|
Člen 24 \| Člen 10(1) \| \| \| \| \| \| \| \| \| \|	Art. 24 \| Art. 10(1) \| \| \| \| \| \| \| \| \| \|
Člen 25 \| Člen 9 \| \| \| \| \| \| \| \| \| \|	Art. 25 \| Art. 9 \| \| \| \| \| \| \| \| \| \|
Člen 26 \| Člen 5 \| \| \| \| \| \| \| \| \| \|	Art. 26 \| Art. 5 \| \| \| \| \| \| \| \| \| \|
Člen 27 \| \| \| Člen 8 \| \| \| \| \| \| \| \|	Art. 27 \| \| \| Art. 8 \| \| \| \| \| \| \| \|
Člen 28(1) \| \| \| Člen 9(3) \| \| \| \| \| \| \| \|	Art. 28(1) \| \| \| Art. 9(3) \| \| \| \| \| \| \| \|
Člen 28(2) \| \| \| Člen 9(1) \| \| \| \| \| \| \| \|	Art. 28(2) \| \| \| Art. 9(1) \| \| \| \| \| \| \| \|
Člen 28(3) \| \| \| Člen 9(2) \| \| \| \| \| \| \| \|	Art. 28(3) \| \| \| Art. 9(2) \| \| \| \| \| \| \| \|
Člen 28(4) \| \| \| Člen 9(4) \| \| \| \| \| \| \| \|	Art. 28(4) \| \| \| Art. 9(4) \| \| \| \| \| \| \| \|
Člen 29 \| \| \| Člen 10 \| \| \| \| \| \| \| \|	Art. 29 \| \| \| Art. 10 \| \| \| \| \| \| \| \|
Člen 30 \| \| \| Člen 11 \| \| \| \| \| \| \| \|	Art. 30 \| \| \| Art. 11 \| \| \| \| \| \| \| \|
Člen 31 \| \| \| Člen 12 \| \| \| \| \| \| \| \|	Art. 31 \| \| \| Art. 12 \| \| \| \| \| \| \| \|
Člen 32 \| \| \| Člen 13 \| \| \| \| \| \| \| \|	Art. 32 \| \| \| Art. 13 \| \| \| \| \| \| \| \|
Člen 33 \| \| \| Člen 14(1) \| \| \| \| \| \| \| \|	Art. 33 \| \| \| Art. 14(1) \| \| \| \| \| \| \| \|
Člen 34 \| \| \| Člen 14(2) do (4) \| \| \| \| \| \| \| \|	Art. 34 \| \| \| Art. 14(2) to (4) \| \| \| \| \| \| \| \|
Člen 35 \| \| \| Člen 15 \| \| \| \| \| \| \| \|	Art. 35 \| \| \| Art. 15 \| \| \| \| \| \| \| \|
Člen 36 \| \| \| Člen. 15a \| \| \| \| \| \| \| \|	Art. 36 \| \| \| Art. 15a \| \| \| \| \| \| \| \|
Člen 37 \| \| \| Člen 15b \| \| \| \| \| \| \| \|	Art. 37 \| \| \| Art. 15b \| \| \| \| \| \| \| \|
Člen 38 \| \| \| Člen 15c \| \| \| \| \| \| \| \|	Art. 38 \| \| \| Art. 15c \| \| \| \| \| \| \| \|
Člen 39 \| \| \| Člen 14(5) \| \| \| \| \| \| \| \|	Art. 39 \| \| \| Art. 14(5) \| \| \| \| \| \| \| \|
Člen 40 \| \| \| Člen 16 \| \| \| \| \| \| \| \|	Art. 40 \| \| \| Art. 16 \| \| \| \| \| \| \| \|
Člen 41 \| \| \| Člen 17 \| \| \| \| \| \| \| \|	Art. 41 \| \| \| Art. 17 \| \| \| \| \| \| \| \|
Člen 42 \| \| \| Člen 18 \| \| \| \| \| \| \| \|	Art. 42 \| \| \| Art. 18 \| \| \| \| \| \| \| \|
Člen 43 \| \| \| Člen 20(1) \| \| \| \| \| \| \| \|	Art. 43 \| \| \| Art. 20(1) \| \| \| \| \| \| \| \|
Člen 44 \| \| \| Člen 20(2) \| \| \| \| \| \| \| \|	Art. 44 \| \| \| Art. 20(2) \| \| \| \| \| \| \| \|
Člen 45 \| \| \| Člen 20(3) \| \| \| \| \| \| \| \|	Art. 45 \| \| \| Art. 20(3) \| \| \| \| \| \| \| \|
Člen 46 \| \| \| Člen 19 \| \| \| \| \| \| \| \|	Art. 46 \| \| \| Art. 19 \| \| \| \| \| \| \| \|
Člen 47 \| \| \| Člen 19a \| \| \| \| \| \| \| \|	Art. 47 \| \| \| Art. 19a \| \| \| \| \| \| \| \|
Člen 48 \| \| \| Člen 21 \| \| \| \| \| \| \| \|	Art. 48 \| \| \| Art. 21 \| \| \| \| \| \| \| \|
Člen 49 \| \| \| Člen 23 \| \| \| \| \| \| \| \|	Art. 49 \| \| \| Art. 23 \| \| \| \| \| \| \| \|
Člen 50 \| \| \| Člen 24 \| \| \| \| \| \| \| \|	Art. 50 \| \| \| Art. 24 \| \| \| \| \| \| \| \|
Člen 51(1) in (2) \| \| \| Člen 22(1) \| \| \| \| \| \| \| \|	Art. 51(1) and (2) \| \| \| Art. 22(1) \| \| \| \| \| \| \| \|
Člen 51(3) \| \| \| Člen 22(2) \| \| \| \| \| \| \| \|	Art. 51(3) \| \| \| Art. 22(2) \| \| \| \| \| \| \| \|
Člen 52 \| \| \| Člen 25 \| \| \| \| \| \| \| \|	Art. 52 \| \| \| Art. 25 \| \| \| \| \| \| \| \|
Člen 53 \| \| \| \| \| \| \| \| \| \| \| Člen 3	Art. 53 \| \| \| \| \| \| \| \| \| \| \| Art. 3
Člen 54 \| \| \| \| \| \| \| \| \| Člen 2(1) \| \|	Art. 54 \| \| \| \| \| \| \| \| \| Art. 2(1) \| \|
Člen 55 \| \| \| \| \| \| \| \| \| Člen 3 \| \|	Art. 55 \| \| \| \| \| \| \| \| \| Art. 3 \| \|
Člen 56 \| \| \| \| \| \| \| \| \| Člen 4(1) \| \|	Art. 56 \| \| \| \| \| \| \| \| \| Art. 4(1) \| \|
Člen 57 \| \| \| \| \| \| \| \| \| Člen 5(2) \| \|	Art. 57 \| \| \| \| \| \| \| \| \| Art. 5(2) \| \|
Člen 58 \| \| \| \| \| \| \| \| \| Člen 6 \| \|	Art. 58 \| \| \| \| \| \| \| \| \| Art. 6 \| \|
Člen 59 \| \| \| \| \| \| \| \| \| Člen 7(1) in (2) \| \|	Art. 59 \| \| \| \| \| \| \| \| \| Art. 7(1) and (2) \| \|
Člen 60 \| \| \| \| \| \| \| \| \| Člen 5(1) in Člen 9 \| \|	Art. 60 \| \| \| \| \| \| \| \| \| Art. 5(1) and Art. 9 \| \|
Člen 61 \| \| \| \| \| \| \| \| \| Člen 10(1) do (4) \| \|	Art. 61 \| \| \| \| \| \| \| \| \| Art. 10(1) to (4) \| \|
Člen 62 \| \| \| \| \| \| \| \| \| Člen 2(2) in \| Člen 7(3) \| \|	Art. 62 \| \| \| \| \| \| \| \| \| Art. 2(2) and \| Art. 7(3) \| \|
Člen 63(1) \| \| \| \| \| \| \| \| \| Člen 4(2) \| \|	Art. 63(1) \| \| \| \| \| \| \| \| \| Art. 4(2) \| \|
Člen 63(2) \| \| \| \| \| \| \| \| \| Člen 8 \| \|	Art. 63(2) \| \| \| \| \| \| \| \| \| Art. 8 \| \|
Člen 63(3) \| \| \| \| \| \| \| \| \| Člen 10(5) \| \|	Art. 63(3) \| \| \| \| \| \| \| \| \| Art. 10(5) \| \|
Člen 64 \| \| \| \| \| \| \| \| \| Člen 11(1) \| \|	Art. 64 \| \| \| \| \| \| \| \| \| Art. 11(1) \| \|
Člen 65 \| \| \| \| \| \| \| \| \| Člen 12 \| \|	Art. 65 \| \| \| \| \| \| \| \| \| Art. 12 \| \|
Člen 66 \| \| \| \| \| Člen 5 \| \| \| \| \| \|	Art. 66 \| \| \| \| \| Art. 5 \| \| \| \| \| \|
Člen 67 \| \| \| \| \| Člen 6(1) \| \| \| \| \| \|	Art. 67 \| \| \| \| \| Art. 6(1) \| \| \| \| \| \|
Člen 68 \| \| \| \| \| \| \| \| \| \| \| Člen 2(2)	Art. 68 \| \| \| \| \| \| \| \| \| \| \| Art. 2(2)
Člen 69 \| \| \| \| \| \| \| \| \| \| \| Člen 7(2) in (3)	Art. 69 \| \| \| \| \| \| \| \| \| \| \| Art. 7(2) and (3)
Člen 70 \| \| \| \| \| \| \| \| Člen 2 \| \| \|	Art. 70 \| \| \| \| \| \| \| \| Art. 2 \| \| \|
Člen 71 \| \| \| \| \| \| \| \| Člen 3 \| \| \|	Art. 71 \| \| \| \| \| \| \| \| Art. 3 \| \| \|
Člen 72 \| \| \| \| \| \| \| \| Člen 4 \| \| \|	Art. 72 \| \| \| \| \| \| \| \| Art. 4 \| \| \|
Člen 73 \| \| \| \| \| \| \| \| Člen 5(1) \| \| \|	Art. 73 \| \| \| \| \| \| \| \| Art. 5(1) \| \| \|
Člen 74 \| \| \| \| \| \| \| \| Člen 5(2) \| \| \|	Art. 74 \| \| \| \| \| \| \| \| Art. 5(2) \| \| \|
Člen 75 \| \| \| \| \| \| \| \| Člen 6(2) \| \| \|	Art. 75 \| \| \| \| \| \| \| \| Art. 6(2) \| \| \|
Člen 76 \| \| \| \| \| \| \| Člen 2 \| \| \| \|	Art. 76 \| \| \| \| \| \| \| Art. 2 \| \| \| \|
Člen 77 \| \| \| \| \| \| \| Člen 3 \| \| \| \|	Art. 77 \| \| \| \| \| \| \| Art. 3 \| \| \| \|
Člen 78 \| \| \| \| \| \| \| Člen 4(1) \| \| \| \|	Art. 78 \| \| \| \| \| \| \| Art. 4(1) \| \| \| \|
Člen 79 \| \| \| \| \| \| \| Člen 5 \| \| \| \|	Art. 79 \| \| \| \| \| \| \| Art. 5 \| \| \| \|
Člen 80 \| \| \| \| \| \| \| Člen 6 \| \| \| \|	Art. 80 \| \| \| \| \| \| \| Art. 6 \| \| \| \|
Člen 81 \| \| \| \| \| \| \| Člen 7 \| \| \| \|	Art. 81 \| \| \| \| \| \| \| Art. 7 \| \| \| \|
Člen 82 \| \| \| \| \| \| \| Člen 8 \| \| \| \|	Art. 82 \| \| \| \| \| \| \| Art. 8 \| \| \| \|
Člen 83 \| \| \| \| \| \| \| Člen 9 \| \| \| \|	Art. 83 \| \| \| \| \| \| \| Art. 9 \| \| \| \|
Člen 84 \| \| \| \| \| \| \| Člen 10 \| \| \| \|	Art. 84 \| \| \| \| \| \| \| Art. 10 \| \| \| \|
Člen 85 \| \| \| \| \| \| \| \| \| \| \| Člen 9	Art. 85 \| \| \| \| \| \| \| \| \| \| \| Art. 9
Člen 86 \| \| \| \| \| \| \| \| \| \| Člen 1(3) in (4) \|	Art. 86 \| \| \| \| \| \| \| \| \| \| Art. 1(3) and (4) \|
Člen 87 \| \| \| \| \| \| \| \| \| \| Člen 2 \|	Art. 87 \| \| \| \| \| \| \| \| \| \| Art. 2 \|
Člen 88 \| \| \| \| \| \| \| \| \| \| Člen 3(1) do (6) \|	Art. 88 \| \| \| \| \| \| \| \| \| \| Art. 3(1) to (6) \|
Člen 89 \| \| \| \| \| \| \| \| \| \| Člen 4 \|	Art. 89 \| \| \| \| \| \| \| \| \| \| Art. 4 \|
Člen 90 \| \| \| \| \| \| \| \| \| \| Člen 5 \|	Art. 90 \| \| \| \| \| \| \| \| \| \| Art. 5 \|
Člen 91 \| \| \| \| \| \| \| \| \| \| Člen 6 \|	Art. 91 \| \| \| \| \| \| \| \| \| \| Art. 6 \|
Člen 92 \| \| \| \| \| \| \| \| \| \| Člen 7 \|	Art. 92 \| \| \| \| \| \| \| \| \| \| Art. 7 \|
Člen 93 \| \| \| \| \| \| \| \| \| \| Člen 8 \|	Art. 93 \| \| \| \| \| \| \| \| \| \| Art. 8 \|
Člen 94 \| \| \| \| \| \| \| \| \| \| Člen 9 \|	Art. 94 \| \| \| \| \| \| \| \| \| \| Art. 9 \|
Člen 95 \| \| \| \| \| \| \| \| \| \| Člen 10 \|	Art. 95 \| \| \| \| \| \| \| \| \| \| Art. 10 \|
Člen 96 \| \| \| \| \| \| \| \| \| \| Člen 11 \|	Art. 96 \| \| \| \| \| \| \| \| \| \| Art. 11 \|
Člen 97(1) do (4) \| \| \| \| \| \| \| \| \| \| Člen 12(1) in (2) \|	Art. 97(1) to (4) \| \| \| \| \| \| \| \| \| \| Art. 12(1) and (2) \|
Člen 97(5) \| \| \| \| \| \| \| \| \| \| Člen 12(4) \|	Art. 97(5) \| \| \| \| \| \| \| \| \| \| Art. 12(4) \|
Člen 98 \| \| \| \| \| \| \| \| \| \| Člen 13 \|	Art. 98 \| \| \| \| \| \| \| \| \| \| Art. 13 \|
Člen 99 \| \| \| \| \| \| \| \| \| \| Člen 14 \|	Art. 99 \| \| \| \| \| \| \| \| \| \| Art. 14 \|
Člen 100 \| \| \| \| \| \| \| \| \| \| \| Člen 6(3)	Art. 100 \| \| \| \| \| \| \| \| \| \| \| Art. 6(3)
Člen 101 \| \| \| Člen 29e \| \| \| \| \| \| \| \|	Art. 101 \| \| \| Art. 29e \| \| \| \| \| \| \| \|
Člen 102 \| \| \| Člen 29a \| \| \| \| \| \| \| \|	Art. 102 \| \| \| Art. 29a \| \| \| \| \| \| \| \|
Člen 103 \| \| \| Člen 29c \| \| \| \| \| \| \| \|	Art. 103 \| \| \| Art. 29c \| \| \| \| \| \| \| \|
Člen 104 \| \| \| Člen 29d \| \| \| \| \| \| \| \|	Art. 104 \| \| \| Art. 29d \| \| \| \| \| \| \| \|
Člen 105 \| \| \| Člen 29f \| \| \| \| \| \| \| \|	Art. 105 \| \| \| Art. 29f \| \| \| \| \| \| \| \|
Člen 106(1) \| \| \| Člen 29g \| \| \| \| \| \| \| \|	Art. 106(1) \| \| \| Art. 29g \| \| \| \| \| \| \| \|
Člen 106(2) \| \| \| Člen 29b, drugi odstavek \| \| \| \| \| \| \| \|	Art. 106(2) \| \| \| Art. 29b, 2nd paragraph \| \| \| \| \| \| \| \|
Člen 107 \| \| \| Člen 29h \| \| \| \| \| \| \| \|	Art. 107 \| \| \| Art. 29h \| \| \| \| \| \| \| \|
Člen 108 \| \| \| Člen 29i \| \| \| \| \| \| \| \|	Art. 108 \| \| \| Art. 29i \| \| \| \| \| \| \| \|
Člen 109 \| \| \| \| \| \| Člen 3(1) do (3) \| \| \| \| \|	Art. 109 \| \| \| \| \| \| Art. 3(1) to (3) \| \| \| \| \|
Člen 110 \| \| \| \| \| \| Člen 3(4) \| \| \| \| \|	Art. 110 \| \| \| \| \| \| Art. 3(4) \| \| \| \| \|
Člen 111(1) \| \| \| Člen 26, prvi in drugi odstavek \| \| \| \| \| \| \| \|	Art. 111(1) \| \| \| Art. 26, 1st and 2nd paragraph \| \| \| \| \| \| \| \|
Člen 111(2) \| \| \| \| Člen 4(1) \| \| \| \| \| \| \|	Art. 111(2) \| \| \| \| Art. 4(1) \| \| \| \| \| \| \|
Člen 111(3) \| \| \| Člen 26, tretji odstavek \| \| \| \| \| \| \| \|	Art. 111(3) \| \| \| Art. 26, 3rd paragraph \| \| \| \| \| \| \| \|
Člen 112 \| Člen 8 \| \| Člen 27 \| \| \| \| \| \| \| \|	Art. 112 \| Art. 8 \| \| Art. 27 \| \| \| \| \| \| \| \|
Člen 113 \| \| \| \| Člen 4(2) \| \| Člen 4(2) \| \| \| \| \|	Art. 113 \| \| \| \| Art. 4(2) \| \| Art. 4(2) \| \| \| \| \|
Člen 114(1) \| \| \| \| Člen 4(3) \| \| \| \| \| \| \|	Art. 114(1) \| \| \| \| Art. 4(3) \| \| \| \| \| \| \|
Člen 114(2) \| \| \| \| \| \| Člen 4(3) \| \| \| \| \|	Art. 114(2) \| \| \| \| \| \| Art. 4(3) \| \| \| \| \|
Člen 115 \| \| \| \| \| \| Člen 4(1) \| \| \| \| \|	Art. 115 \| \| \| \| \| \| Art. 4(1) \| \| \| \| \|
Člen 116 \| Člen 11 \| \| \| \| \| \| \| \| \| \|	Art. 116 \| Art. 11 \| \| \| \| \| \| \| \| \| \|
Člen 117 \| \| \| Člen 28 \| \| \| \| \| \| \| \|	Art. 117 \| \| \| Art. 28 \| \| \| \| \| \| \| \|
Člen 118 \| \| \| Člen 29 \| \| \| \| \| \| \| \|	Art. 118 \| \| \| Art. 29 \| \| \| \| \| \| \| \|
Člen 119 \| \| \| \| \| \| \| \| \| \| \| Člen 4(1)	Art. 119 \| \| \| \| \| \| \| \| \| \| \| Art. 4(1)
Člen 120 \| \| Člen 2a, prvi odstavek \| \| \| \| \| \| \| \| \|	Art. 120 \| \| Art. 2a, 1st paragraph \| \| \| \| \| \| \| \| \|
Člen 121 \| \| Člen 2b \| Člen 37a \| \| \| \| \| \| \| \|	Art. 121 \| \| Art. 2b \| Art. 37a \| \| \| \| \| \| \| \|
Člen 122 \| \| \| Člen 30 \| \| \| \| \| \| \| \|	Art. 122 \| \| \| Art. 30 \| \| \| \| \| \| \| \|
Člen 123 \| \| \| Člen 33 \| \| \| \| \| \| \| \|	Art. 123 \| \| \| Art. 33 \| \| \| \| \| \| \| \|
Člen 124 \| \| \| \| \| \| \| \| \| \| \| Člen 5	Art. 124 \| \| \| \| \| \| \| \| \| \| \| Art. 5
Člen 125 \| Člen 12 \| \| Člen 31 \| \| \| \| Člen 4(2) \| \| Člen 11(2) \| Člen 12(3) \|	Art. 125 \| Art. 12 \| \| Art. 31 \| \| \| \| Art. 4(2) \| \| Art. 11(2) \| Art. 12(3) \|
Člen 126, prvi odstavek \| Člen 21 \| \| \| \| \| \| \| \| \| \|	Art. 126, 1st paragraph \| Art. 21 \| \| \| \| \| \| \| \| \| \|
Člen 126, drugi odstavek \| \| \| Člen 32 \| \| \| \| \| \| \| \|	Art. 126, 2nd paragraph \| \| \| Art. 32 \| \| \| \| \| \| \| \|
Člen 127 \| \| \| Člen 28a \| \| \| \| \| \| \| \|	Art. 127 \| \| \| Art. 28a \| \| \| \| \| \| \| \|
Člen 128 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —	Art. 128 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —
Člen 129 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —	Art. 129 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —
Člen 130 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —	Art. 130 \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —
Priloga I \| \| Priloga \| \| \| \| \| \| \| \| \|	Annex I \| \| Annex \| \| \| \| \| \| \| \| \|
Priloga II \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —	Annex II \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —
Priloga III \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —	Annex III \| — \| — \| — \| — \| — \| — \| — \| — \| — \| — \| —
( 1 ) UL L 324, 10.12.2007, str. 121.	( 1 ) OJ L 324, 10.12.2007, p. 121.
( 2 ) UL L 136, 30.4.2004, str. 1.	( 2 ) OJ L 136, 30.4.2004, p. 1.
( 3 ) UL L 121, 1.5.2001, str. 34.	( 3 ) OJ L 121, 1.5.2001, p. 34.
( 4 ) UL L 136, 30.4.2004, str. 1. Uredba, kakor je bila spremenjena z Uredbo (ES) št. 1901/2006 (UL L 378, 27.12.2006, str. 1).	( 4 ) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
( 5 ) UL L 207, 30.7.1986, str. 1.	( 5 ) OJ L 207, 30.7.1986, p. 1.
( 6 ) UL L 210, 7.8.1985, str. 29. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 1999/34/ES Evropskega parlamenta in Sveta (UL L 141, 4.6.1999, str. 20).	( 6 ) OJ L 210, 7.8.1985, p. 29. Directive as last amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20).
( 7 ) UL L 378, 27.12.2006, str. 1. ◄	( 7 ) OJ L 378, 27.12.2006, p. 1. ◄
( 8 ) UL L 18, 22.1.2000, str. 1.	( 8 ) OJ L 18, 22.1.2000, p. 1.
( 9 ) UL L 262, 14.10.2003, p. 22.	( 9 ) OJ L 262, 14.10.2003, p. 22.
( 10 ) Uredba Komisije (ES) št. 1234/2008 z dne 24. novembra 2008 o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini (UL L 334, 12.12.2008, str. 7).	( 10 ) Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).
( 11 ) UL L 147, 9.6.1975, str. 23.	( 11 ) OJ L 147, 9.6.1975, p. 23.
( 12 ) UL L 204, 21.7.1998, str. 37.	( 12 ) OJ L 204, 21.7.1998, p. 37.
( 13 ) UL L 178, 17.7.2000, str. 1.	( 13 ) OJ L 178, 17.7.2000, p. 1.
( 14 ) UL L 33, 8.2.2003, str. 30.	( 14 ) OJ L 33, 8.2.2003, p. 30.
( 15 ) UL L 123, 12.5.2016, str. 1.	( 15 ) OJ L 123, 12.5.2016, p. 1.
( 16 ) Mednarodna konferenca o usklajevanju tehničnih zahtev za pridobitev dovoljenja za promet z zdravilom za ljudi.	( 16 ) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
( 17 ) UL L 193, 17.7.1991, str. 30.	( 17 ) OJ L 193, 17.7.1991, p. 30.
( 18 ) UL L 121, 1.5.2001, str. 34.	( 18 ) OJ L 121, 1.5.2001, p. 34.
( 19 ) UL L 15, 17.1.1987, str. 29.	( 19 ) OJ L 15, 17.1.1987, p. 29.
( 20 ) UL L 145, 11.6.1988, str. 35.	( 20 ) OJ L 145, 11.6.1988, p. 35.
( 21 ) UL L 159, 27.6.2003, str. 1.	( 21 ) See p. 1 of this Official Journal.
( 22 ) UL L 159, 27.6.2003, str. 24.	( 22 ) See p. 24 of this Official Journal.
( 23 ) UL L 106. 17.4.2001. str. 1.	( 23 ) OJ L 106, 17.4.2001, p. 1.
( 24 ) Uredba (EU) 2017/745 Evropskega parlamenta in Sveta z dne 5. aprila 2017 o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS (UL L 117, 5.5.2017, str. 1).	( 24 ) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
( 25 ) UL L 11, 14.1.1978, str. 18.	( 25 ) OJ L 11, 14.1.1978, p. 18.
( 26 ) UL L 237, 10.9.1994, str. 13.	( 26 ) OJ L 237, 10.9.1994, p. 13.
( 27 ) UL L 313, 13.12.2000, str. 22.	( 27 ) OJ L 313, 13.12.2000, p. 22.
( 28 ) UL L 55, 11.3.1995, str. 15.	( 28 ) OJ L 55, 11.3.1995, p. 15.
( 29 ) UL L 214, 24.8.1993, str. 1.	( 29 ) OJ L 214, 24.8.1993, p. 1.
( 30 ) UL L 102, 7.4.2004, str. 48.	( 30 ) OJ L 102, 7.4.2004, p. 48.
( 31 ) UL L 169, 12.7.1993, str. 1.	( 31 ) OJ L 169, 12.7.1993, p. 1.
( 32 ) UL L 189, 20.7.1990, str. 17.	( 32 ) OJ L 189, 20.7.1990, p. 17.
( 33 ) UL L 105, 26.4.2003, str. 18.	( 33 ) OJ L 105, 26.4.2003, p. 18.

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