MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   NL

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   BG

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   CS

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   DA

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   DE

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Ravimi müügiloa andmise aluseks olevate tingimuste muudatuste liigid ning muudatuste taotlemise tingimused ja kord

   Ravimi müügiloa andmise aluseks olevate tingimuste muudatuste liigid ning muudatuste taotlemise tingimused ja kord
   ET

   Translation failed   :  

   Official publication: Elektrooniline Riigi Teataja ; Number: RTL 2010, 10, 181

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   EN

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Προσαρμογή της Ελληνικής Νομοθεσίας προς τη Κοινοτική οδηγία 2009/53/ΕΚ του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου «για την τρο− ποποίηση της οδηγίας 2001/82/ΕΚ και της οδηγί− ας 2001/83/ΕΚ σχετικά με τις τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων». − Τροποποίηση και συμπλήρωση της ΚΥΑ ΔΥΓ3(α)83657/2005 (ΦΕΚ Β΄59/2006)».

   Προσαρμογή της Ελληνικής Νομοθεσίας προς τη Κοινοτική οδηγία 2009/53/ΕΚ του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου «για την τρο− ποποίηση της οδηγίας 2001/82/ΕΚ και της οδηγί− ας 2001/83/ΕΚ σχετικά με τις τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων». − Τροποποίηση και συμπλήρωση της ΚΥΑ ΔΥΓ3(α)83657/2005 (ΦΕΚ Β΄59/2006)».
   EL

   Translation failed   :  

   Official publication: Εφημερίς της Κυβερνήσεως (ΦΕΚ) (Τεύχος B) ; Number: 2235 ; Publication date: 2010-12-31 ; Page: 38199-38199

MACHINE TRANSLATION MACHINE TRANSLATION

1. Real Decreto 1091/2010, de 3 de septiembre, por el que se modifica el Real Decreto 1345/2007, de 11 de octubre, por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente, y el Real Decreto 1246/2008, de 18 de julio, por el que se regula el procedimiento de autorización, registro y farmacovigilancia de los medicamentos veterinarios fabricados industrialmente

   Real Decreto 1091/2010, de 3 de septiembre, por el que se modifica el Real Decreto 1345/2007, de 11 de octubre, por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente, y el Real Decreto 1246/2008, de 18 de julio, por el que se regula el procedimiento de autorización, registro y farmacovigilancia de los medicamentos veterinarios fabricados industrialmente
   ES

   Translation failed   :  

   Official publication: Boletín Oficial del Estado ( B.O.E ) ; Number: 247/2010 ; Publication date: 2010-10-12 ; Page: 86228-86241

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   FR

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Zakon o veterinarsko-medicinskim proizvodima

   Zakon o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 84/08

2. Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima

   Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 56/13

3. Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima

   Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 73/09

4. Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima

   Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 14/10

5. Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima

   Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 32/11

6. Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima

   Pravilnik o izmjenama i dopunama Pravilnika o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 67/13

7. Pravilnik o veterinarsko-medicinskim proizvodima

   Pravilnik o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 30/09

8. Zakon o lijekovima

   Zakon o lijekovima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 76/2013

9. Pravilnik o farmakovigilanciji

   Pravilnik o farmakovigilanciji
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 83/2013

10. Pravilnik o davanju odobrenja za stavljanje lijeka u promet

    Pravilnik o davanju odobrenja za stavljanje lijeka u promet
    HR

    Translation failed   :  

    Official publication: Narodne Novine ; Number: 83/2013

11. Pravilnik o uvjetima za davanje proizvodne dozvole, zahtjevima dobre proizvođačke prakse te potvrdi o provođenju dobre proizvođačke prakse za lijekove

    Pravilnik o uvjetima za davanje proizvodne dozvole, zahtjevima dobre proizvođačke prakse te potvrdi o provođenju dobre proizvođačke prakse za lijekove
    HR

    Translation failed   :  

    Official publication: Narodne Novine ; Number: 83/2013

12. Pravilnik o dobroj praksi u prometu lijekova, davanju dozvola za promet na veliko lijekovima, davanju dozvola za posredovanje lijekovima i davanju potvrde o dobroj praksi u prometu lijekovima na veliko

    Pravilnik o dobroj praksi u prometu lijekova, davanju dozvola za promet na veliko lijekovima, davanju dozvola za posredovanje lijekovima i davanju potvrde o dobroj praksi u prometu lijekovima na veliko
    HR

    Translation failed   :  

    Official publication: Narodne Novine ; Number: 83/2013

13. Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima

    Zakon o izmjenama i dopunama Zakona o veterinarsko-medicinskim proizvodima
    HR

    Translation failed   :  

    Official publication: Narodne Novine ; Number: 15/15

1. Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima

   Pravilnik o izmjeni Pravilnika o veterinarsko-medicinskim proizvodima
   HR

   Translation failed   :  

   Official publication: Narodne Novine ; Number: 146/10

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   IT

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Ο Περί Κτηνιατρικών Φαρμακευτικών Προϊόντων (Έλεγχος Ποιότητας, Εγγραφή, Κυκλοφορία, Παρασκευή, Χορήγηση και Χρήση) (Τροποποιητικός) Νόμος του 2011.

   Ο Περί Κτηνιατρικών Φαρμακευτικών Προϊόντων (Έλεγχος Ποιότητας, Εγγραφή, Κυκλοφορία, Παρασκευή, Χορήγηση και Χρήση) (Τροποποιητικός) Νόμος του 2011.
   EL

   Translation failed   :  

   Official publication: Cyprus Gazette ; Number: 4281 ; Publication date: 2011-04-21 ; Page: 00524-00530

2. Ο περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) (Τρoποποιητικός) Νόμος του 2011.

   Ο περί Φαρμάκων Ανθρώπινης Χρήσης (Έλεγχος Ποιότητας, Προμήθειας και Τιμών) (Τρoποποιητικός) Νόμος του 2011.
   EL

   Translation failed   :  

   Official publication: Cyprus Gazette ; Number: 4287 ; Publication date: 2011-07-15 ; Page: 00751-00752

MACHINE TRANSLATION MACHINE TRANSLATION

1. Ministru kabineta 2006.gada 9.maija noteikumi Nr. 376 "Zāļu reģistrēšanas kārtība"

   Ministru kabineta 2006.gada 9.maija noteikumi Nr. 376 "Zāļu reģistrēšanas kārtība"
   LV

   Translation failed   :  

   Official publication: Latvijas Vēstnesis ; Number: 97 ; Publication date: 2006-06-22

MACHINE TRANSLATION MACHINE TRANSLATION

1. Dėl 2009 m. birželio 18 d. Europos Parlamento ir Tarybos direktyvos 2009/53/EB, iš dalies keičiančios direktyvos 2001/82/EB ir direktyvos 2001/83/ EB nuostatas dėl leidimų prekiauti vaistais sąlygų keitimo

   Dėl 2009 m. birželio 18 d. Europos Parlamento ir Tarybos direktyvos 2009/53/EB, iš dalies keičiančios direktyvos 2001/82/EB ir direktyvos 2001/83/ EB nuostatas dėl leidimų prekiauti vaistais sąlygų keitimo
   LT

   Translation failed   :  

   Official publication: Administracinės priemonės ; Number: 10-(20.2-50)-694 ; Publication date: 2011-01-31

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   FR

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Comment

   Comment
   HU

   Translation failed   :  

   Official publication: Administrative measures ; Publication date: 2011-05-10

MACHINE TRANSLATION MACHINE TRANSLATION

1. ACT No. III of 2003 AN ACT enacted by the Parliament of Malta. AN ACT to make provision for matters connected with the manufacture, preparation and assembly, wholesale distribution, storage, destruction, disposal, advertising and authorisation of medical products and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and related pharmaceutical activities and for any other matters ancillary thereto or connected therewith.

   ACT No. III of 2003 AN ACT enacted by the Parliament of Malta. AN ACT to make provision for matters connected with the manufacture, preparation and assembly, wholesale distribution, storage, destruction, disposal, advertising and authorisation of medical products and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and related pharmaceutical activities and for any other matters ancillary thereto or connected therewith.
   EN

   Translation failed   :  

   Official publication: The Malta government gazette ; Number: 17369 ; Publication date: 2003-03-05 ; Page: 00135-00260

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   NL

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   DE

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. Ustawa z dnia 18 marca 2011 r. o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

   Ustawa z dnia 18 marca 2011 r. o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
   PL

   Translation failed   :  

   Official publication: Dziennik Ustaw ; Number: 2011/82/451 ; Publication date: 2011-04-19

MACHINE TRANSLATION MACHINE TRANSLATION

1. Ministério da Agricultura, do Desenvolvimento Rural e das Pescas Transpõe para a ordem jurídica nacional a Directiva n.º 2009/9/CE, da Comissão, de 10 de Fevereiro, que altera a Directiva n.º 2001/82/CE, do Parlamento Europeu e do Conselho, de 6 de Novembro, que estabelece um código comunitário relativo aos medicamentos veterinários, e procede à primeira alteração ao Decreto-Lei n.º 148/2008, de 29 de Julho

   Ministério da Agricultura, do Desenvolvimento Rural e das Pescas Transpõe para a ordem jurídica nacional a Directiva n.º 2009/9/CE, da Comissão, de 10 de Fevereiro, que altera a Directiva n.º 2001/82/CE, do Parlamento Europeu e do Conselho, de 6 de Novembro, que estabelece um código comunitário relativo aos medicamentos veterinários, e procede à primeira alteração ao Decreto-Lei n.º 148/2008, de 29 de Julho
   PT

   Translation failed   :  

   Official publication: Diaro da Republica I ; Number: 209 ; Publication date: 2009-10-28 ; Page: 08106-08215

MACHINE TRANSLATION MACHINE TRANSLATION

1. Legea nr. 115/2011 pentru completarea Legii nr. 95/2006 privind reforma în domeniul sănătăţii

   Legea nr. 115/2011 pentru completarea Legii nr. 95/2006 privind reforma în domeniul sănătăţii
   RO

   Translation failed   :  

   Official publication: Monitorul Oficial al României ; Number: 429 ; Publication date: 2011-06-20 ; Page: 00006-00007

MACHINE TRANSLATION MACHINE TRANSLATION

1. Pravilnik o dovoljenju za promet z zdravilom za uporabo v humani medicini

   Pravilnik o dovoljenju za promet z zdravilom za uporabo v humani medicini
   SL

   Translation failed   :  

   Official publication: Uradni list RS ; Number: 109/2010 ; Publication date: 2010-12-30 ; Page: 16930-16939

2. Pravilnik o dovoljenju za promet z zdravilom za uporabo v veterinarski medicini

   Pravilnik o dovoljenju za promet z zdravilom za uporabo v veterinarski medicini
   SL

   Translation failed   :  

   Official publication: Uradni list RS ; Number: 16/2011 ; Publication date: 2011-03-07 ; Page: 01947-01957

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   SK

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

2. Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov

   Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov
   SK

   Translation failed   :  

   Official publication: Zbierka zákonov SR ; Number: 117 ; Publication date: 2011-10-29

MACHINE TRANSLATION MACHINE TRANSLATION

1. Lääkealan turvallisuus- ja kehittämiskeskuksen määräys nro 1/2009: Lääkevalmisteen myyntiluvan ja rekisteröinnin hakeminen ja ylläpitäminen / Säkerhets- och utvecklingscentret för läkemedelsområdets föreskrift 1/2009: Ansökan om och upprätthållande av försäljningstillstånd för och registrering av läkemedel

   Lääkealan turvallisuus- ja kehittämiskeskuksen määräys nro 1/2009: Lääkevalmisteen myyntiluvan ja rekisteröinnin hakeminen ja ylläpitäminen / Säkerhets- och utvecklingscentret för läkemedelsområdets föreskrift 1/2009: Ansökan om och upprätthållande av försäljningstillstånd för och registrering av läkemedel
   FI

   Translation failed   :  

   Official publication: Hallinnolliset toimet ; Number: 1/2009

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   SV

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary

MACHINE TRANSLATION MACHINE TRANSLATION

1. EM estime MNE non nécessaire - MS does not consider NEM necessary.

   Member State does not consider the transposition necessary.
   EM estime MNE non nécessaire - MS does not consider NEM necessary.
   EN

   Translation failed   :  

   Publication date: 1001-01-01 ; Transposition declaration: Not necessary