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COUNCIL DIRECTIVE

RAADETS DIREKTIV

of 16 September 1985

af 16. september 1985

concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy

om samordning af love og administrative bestemmelser om visse former for virksomhed paa det farmaceutiske omraade

(85/432/EEC)

(85/432/EOEF)

THE COUNCIL OF THE EUROPEAN

RAADET FOR DE EUROPAEISKE

COMMUNITIES,

FAELLESSKABER HAR -

Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49 and 57 thereof,

under henvisning til traktaten om oprettelse af Det europaeiske oekonomiske Faellesskab, saerlig artikel 49 og 57,

Having regard to the proposal from the Commission (1),

under henvisning til forslag fra Kommissionen (1),

Having regard to the opinion of the European Parliament (2),

under henvisning til udtalelse fra Europa-Parlamentet (2),

Having regard to the opinion of the Economic and Social Committee (3),

under henvisning til udtalelse fra Det oekonomiske og sociale Udvalg (3), og

Whereas persons who hold a diploma, certificate or other formal qualification in pharmacy are for that reason specialists in the field of medicinal products and, in principle, must have access in all the Member States to a minimum range of activities in that field; whereas, in defining that minimum range, this Directive does not have the effect of limiting the activities accessible in the Member States to pharmacists, in particular with regard to medical biology analyses, and does not give them any monopoly, since the creation of a monopoly continues to be a matter for the Member States alone;

ud fra foelgende betragtninger:

Whereas, moreover, this Directive does not ensure coordination of all conditions of access to and pursuit of activities in the field of pharmacy; whereas, in particular, the geographical distribution of pharmacies and the monopoly of the supply of medicinal products continue to be matters for the Member States;

Personer, der er indehavere af et eksamensbevis, certifikat eller andet kvalifikationsbevis i farmaci, anerkendes herved som specialister paa laegemiddelomraadet og skal i princippet i alle medlemsstaterne have adgang til et vist mindstemaal af virkefelter paa dette omraade; selv om der i dette direktiv fastlaegges et saadant mindstemaal af virkefelter, indebaerer dette hverken nogen begraensning af de former for virksomhed, farmaceuter har adgang til i medlemsstaterne, saerlig med hensyn til biomedicinske analyser, eller noget monopol for disse erhvervsudoevere, idet indfoerelsen af et eventuelt monopol fortsat alene henhoerer under medlemsstaternes kompetence;

Whereas, with a view to achieving mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, as required by Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy (4), the broad comparability of training courses in the Member States enables coordination in this field to be confined to the requirement that minimum standards be observed, thus leaving the Member States freedom of organization as regards teaching;

ved dette direktiv tilsigtes der i oevrigt ikke en samordning af alle betingelser for adgang til og udoevelse af virksomhed paa det farmaceutiske omraade; saaledes henhoerer blandt andet den geografiske fordeling af apoteker og spoergsmaal om monopol paa udlevering af laegemidler fortsat under medlemsstaternes kompetence;

Whereas this Directive does not prevent the Member States from requiring supplementary conditions of training for access to activities not included in the coordinated minimum range of activities; whereas for this reason a host Member State which lays down such conditions may subject thereto nationals of Member States who hold one of the diplomas referred to in Article 4 of Directive 85/433/EEC;

ved gennemfoerelsen af den gensidige anerkendelse af eksamensbeviser, certifikater og andre kvalifikationsbeviser i farmaci, som foreskrevet i Raadets direktiv 85/433/EOEF af 16. september 1985 om gensidig anerkendelse af eksamensbeviser, certifikater og andre kvalifikationsbeviser i farmaci samt om foranstaltninger der skal lette den faktiske udoevelse af etableringsretten i forbindelse med visse former for virksomhed paa det farmaceutiske omraade (4), kan samordningen inden for dette omraade, da uddannelserne i de forskellige medlemsstater i vid udstraekning er sammenlignelige, begraenses til et krav om overholdelse af minimumsnormer, idet det i oevrigt overlades til medlemsstaterne frit at tilrettelaegge deres undervisning;

Whereas the coordination provided for by this Directive covers professional qualifications; whereas, as regards such qualifications, most Member States do not at present distinguish between professional persons who pursue their activities as employed persons and those who are self-employed; whereas, for this reason, it appears necessary to extend the application of this Directive to employed professional persons;

dette direktiv er ikke til hinder for, at medlemsstaterne kan kraeve yderligere uddannelse som betingelse for adgang til former for virksomhed, der ikke indgaar i det ved samordningen fastlagte mindstemaal af virkefelter; en vaertsmedlemsstat, der stiller saadanne krav, kan derfor forlange disse opfyldt af statsborgere fra medlemsstaterne, der er indehavere af et af de i artikel 4 i direktiv 85/433/EOEF omhandlede eksamensbeviser;

Whereas further training is being developed in the Member States in certain aspects of pharmacy which is intended to extend certain areas of knowledge acquired during the training of pharmacists; whereas, therefore, with a view to mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy specialities and in order to put all members of the profession who are nationals of the Member States on an equal footing within the Community, some coordination of the requirements for training in pharmacy specialities is necessary where there are specialized forms of training common to several Member States which can entitle a person to use a specialist title, without such training being a condition of access to the activities included in the coordinated minimum range of activities; whereas such coordination does not seem possible at this stage, but constitutes an objective to be attained as soon as possible together with the relevant mutual recognition,

den i dette direktiv fastsatte samordning gaelder de faglige kvalifikationer; hvad angaar disse, sondres der for tiden i de fleste medlemsstater ikke mellem, om de paagaeldende erhvervsudoevere er loenmodtagere eller selvstaendige erhvervsdrivende; det synes derfor noedvendigt at udstraekke anvendelsesomraadet for dette direktiv til ogsaa at omfatte loenmodtagere;

HAS ADOPTED THIS DIRECTIVE:

der oprettes i medlemsstaterne supplerende uddannelser inden for visse omraader af farmaci; saadanne uddannelser tager sigte paa at udbygge den viden, der er opnaaet under farmaceutuddannelsen; under disse omstaendigheder og med henblik paa gensidig anerkendelse af eksamensbeviser, certifikater og andre kvalifikationsbeviser for specialfarmaceuter, samt for at saette samtlige udoevere af erhvervet, som er statsborgere i medlemsstaterne, paa nogenlunde lige fod inden for Faellesskabet, maa der gennemfoeres en vis samordning af uddannelsesbetingelserne for specialfarmaceuter, saafremt der for flere medlemsstater findes faelles specialistuddannelser, og disse uddannelser, uden at vaere en betingelse for adgang til at optage og udoeve virksomhed inden for det ved samordningen fastlagte mindstemaal af virkefelter for saadan virksomhed, dog kan taenkes at ville udgoere en betingelse for benyttelsen af en specialfarmaceuttitel; en saadan samordning synes ikke mulig paa indevaerende stadium, men udgoer dog sammen med den gensidige anerkendelse et maal, der boer naas saa hurtigt som muligt -

Article 1

UDSTEDT FOELGENDE DIREKTIV:

1. Member States shall ensure that holders of a diploma, certificate or other university or equivalent qualification in pharmacy which meets the conditions laid down in Article 2 shall be entitled at least to access to the activities mentioned in paragraph 2 and to pursue such activities subject, where appropriate, to the requirement of additional professional experience.

Artikel 1

2. The activities referred to in paragraph 1 are:

1. Medlemsstaterne drager omsorg for, at indehavere af et eksamensbevis, certifikat eller andet kvalifikationsbevis i farmaci, der er udstedt af et universitet eller en tilsvarende hoejere uddannelsesinstitution, og som opfylder betingelserne i artikel 2, faar adgang til at udoeve i det mindste de i stk. 2 naevnte former for virksomhed, forudsat at et eventuelt krav om supplerende faglig erfaring er opfyldt.

- the preparation of the pharmaceutical form of medicinal products,

2. De i stk. 1 omhandlede former for virksomhed omfatter:

- the manufacture and testing of medicinal products,

- galenisk udvikling af laegemidler,

- the testing of medicinal products in a laboratory for the of medicinal of medicinal products,

- fremstilling af og kontrol med laegemidler,

- the storage, preservation and distribution of medicinal products at the wholesale stage,

- kontrol af laegemidler i et hertil indrettet laboratorium,

- the preparation, testing, storage and supply of medicinal products in pharmacies open to the public,

- oplagring, opbevaring og distribution af laegemidler i engrosleddet,

- the preparation, testing, storage and dispensing of medicinal products in hospitals,

- tilberedning af, kontrol med samt oplagring og udlevering af laegemidler paa offentligt tilgaengelige apoteker,

- the provisions of information and advice on medicinal products.

- tilberedning af, kontrol med samt oplagring og udlevering af laegemidler paa hospitaler,

3. Where at the time of adoption of this Directive a system of competition based on tests exists in a Member State for the purpose of selecting from among the holders referred to in paragraph 1 those to be appointed to control the new pharmacies to be set up under a national geographical distribution system, that Member State may, by way of derogation from paragraph 1, retain this competition system and may oblige nationals of the Member States holding the diplomas, certificates and other formal qualifications in pharmacy referred to in Article 2 (1) and Article 6 of Directive 85/433/EEC to take part in such a competition.

- information om laegemidler og raadgivning vedroerende disse.

Article 2

3. Saafremt der i en medlemsstat paa tidspunktet for vedtagelsen af dette direktiv er ivaerksat en udvaelgelsesproeve med det formaal blandt de i stk. 1 omhandlede farmaceutiske kandidater at udvaelge dem, som skal lede nye apoteker, der aabnes som led i en national ordning til bedre geografisk fordeling, kan denne medlemsstat, uanset stk. 1, fortsaette denne udvaelgelsesproeve og aabne adgang hertil for andre medlemsstaters statsborgere, der er i besiddelse af de i artikel 2, stk. 1, og i artikel 6 i direktiv 85/433/EOEF naevnte eksamensbeviser, certifikater og andre kvalifikationsbeviser.

Member States shall subordinate the award of the diplomas, certificates and other formal qualifications referred to in Article 1 to the following minimum conditions:

Artikel 2

1. Training leading to the award of the diploma, certificate or other formal qualification shall ensure:

Medlemsstaterne goer udstedelsen af de i artikel 1 omhandlede eksamensbeviser, certifikater og andre kvalifikationsbeviser betinget af, at foelgende minimumskrav er opfyldt:

(a) adequate knowledge of medicines and the substances used in the manufacture of medicines;

1. Den uddannelse, der foerer til erhvervelse af eksamensbeviset, certifikatet eller kvalifikationsbeviset, sikrer, at kandidaten har:

(b) adequate knowledge of pharmaceutical technology and the physical, chemical, biological and microbiological testing of medicinal products;

a) et fyldestgoerende kendskab til de til fremstilling af laegemidler anvendete laegemidler og stoffer;

(c) adequate knowledge of the metabolism and the effects of medicinal products and of the action of toxic substances, and of the use of medicinal products;

b) et fyldestgoerende kendskab til farmaceutisk teknologi samt til fysisk, kemisk, biologisk og mikrobiologisk kontrol med laegemidler;

(d) adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge;

c) et fyldestgoerende kendskab til laegemidlers nedbrydning og virkninger, til giftstoffers virkemaade samt til anvendelsen af laegemidler;

(e) adequate knowledge of the legal and other requirements associated with the practice of pharmacy.

d) et fyldestgoerende kendskab, der goer det muligt at vurdere de videnskabelige data vedroerende laegemidler, for paa dette grundlag at kunne give relevante oplysninger;

2. In order to be accepted for such training, the candidate must have a diploma or a certificate which entitles him to be admitted for the course of study concerned to the universities of a Member State or to higher education institutions recognized as having equivalent status.

e) et fyldestgoerende kendskab til lovbestemte og andre betingelser for udoevelse af farmaceutisk virksomhed.

3. The diploma, certificate or other formal qualification shall testify to the completion of a course of training covering a period of at least five years and comprising:

2. Adgang til denne uddannelse forudsaetter, at den studerende er i besiddelse af et eksamensbevis eller certifikat, som giver ham adgang til det paagaeldende studium ved universiteter eller laereanstalter paa tilsvarende niveau i en medlemsstat.

- at least four years of full-time theoretical and practical training in a university, in a higher education institution of a level recognized as having equivalent status, or under the supervision of a university,

3. Eksamensbeviset, certifikatet eller kvalifikationsbeviset udstedes efter en uddannelse, der straekker sig over mindst fem aar, og som omfatter:

- at least six months of in-service training in a pharmacy open to the public or in a hospital under the supervision of the pharamaceutical department of that hospital. 4. By way of derogation from point 3:

- mindst fire aars teoretisk og praktisk undervisning paa heltidsbasis paa et universitet eller en tilsvarende hoejere laereanstalt eller under opsyn af et universitet,

(a) if at the time of the adoption of this Directive two courses of training coexist in a Member State, one of which lasts five years and the other four years, the diploma, certificate or other formal qualification testifying to the completion of the four-year course of training, shall be considered to fulfil the condition concerning duration referred to in point 3 provided that the diplomas, certificates or other formal qualifications testifying to the completion of the two courses of training are recognized as equivalent by that State;

- mindst seks maaneders praktikanttjeneste paa et for offentligheden tilgaengeligt apotek eller paa et hospital under opsyn af dette hospitals farmaceutiske tjeneste. 4. Uanset nr. 3 gaelder foelgende:

(b) if, because, there are insufficient places in pharmacies open to the public and in hospitals near training establishments, a Member State is unable to provide six months of in-service training, it may, for a period of five years following the expiry of the time limit laid down in Article 5, make provision for no more than half of that training period to involve activities as a pharmacist in an undertaking which manufactures medicinal products.

a) eksisterer der paa tidspunktet for vedtagelsen af dette direktiv i en medlemsstat to uddannelser, som straekker sig over henholdsvis fem og fire aar, betragtes det eksamensbevis, certifikat eller andet kvalifikationsbevis, hvormed den fireaarige uddannelse afsluttes, som opfyldende den i nr. 3 omhandlede varighedsbetingelse, saafremt eksamensbeviser, certifikater eller andre kvalifikationsbeviser, hvormed de to uddannelser afsluttes, af denne stat anerkendes som svarende til hinanden;

5. The course of training referred to in point 3 shall comprise as a minimum theoretical and practical training in the following subjects:

b) saafremt en medlemsstat paa grund af et utilstraekkeligt antal pladser i apoteker, der er tilgaengelige for offentligheden, og i hospitaler, der ligger i umiddelbar naerhed af en undervisningsinstitution, ikke er i stand til at sikre seks maaneders praktikanttjeneste, kan den i en periode paa fem aar efter udloebet af den i artikel 5 naevnte tidsfrist bestemme, at hoejst halvdelen af denne praktikanttjeneste omfatter farmaceutisk arbejde i en virksomhed, der fremstiller laegemidler.

- Plant and animal biology,

5. Den i nr. 3 omhandlede uddannelse omfatter teoretisk og praktisk undervisning i mindst foelgende fag:

- Physics,

- Plante- og dyrebiologi

- General and inorganic chemistry,

- Fysik

- Organic chemistry,

- Almen og uorganisk kemi

- Analytical chemistry,

- Organisk kemi

- Pharmaceutical chemistry, including analysis of medicinal products,

- Analytisk kemi

- General and applied biochemistry (medical),

- Farmaceutisk kemi, herunder laegemiddelanalyse

- Anatomy and physiology; medical terminology,

- Almindelig og anvendt biokemi (medicinsk)

- Microbiology,

- Anatomi og fysiologi; medicinsk terminologi

- Pharmacology and pharmacotherapy,

- Mikrobiologi

- Pharmaceutical technology,

- Farmakologi og farmakoterapi

- Toxicology,

- Farmaceutisk teknologi

- Pharmacognosy,

- Toksikologi

- Legislation and, where appropriate, professional ethics.

- Farmakognosi

The balance between theoretical and practical training shall, in respect of each subject, give sufficient importance to theory to maintain the university character of the training.

- Lovgivning og i givet fald erhvervsetik.

Article 3

I fordelingen mellem teoretisk og praktisk uddannelse skal der for hvert fags vedkommende laegges tilstraekkelig vaegt paa teorien til, at uddannelsens akademiske praeg bevares.

Not more than three years after the expiry of the time limit laid down in Article 5, the Commission shall submit to the Council appropriate proposals on specializations in pharmacy and in particular hospital pharmacy. The Council shall examine these proposals within one year.

Artikel 3

Article 4

Senest tre aar efter udloebet af den i artikel 5 fastsatte frist forelaegger Kommissionen passende forslag for Raadet vedroerende specialisering inden for farmaci, herunder navnlig hospitalsfarmaci. Raadet behandler forslagene inden for en frist paa et aar.

This Directive shall also apply to nationals of Member States who, in accordance with Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1), are pursuing or will pursue, as employed persons, one of the activities referred to in Article 1 of Directive 85/433/EEC.

Artikel 4

Article 5

Dette direktiv finder ligeledes anvendelse paa statsborgere i medlemsstaterne, som i henhold til Raadets forordning (EOEF) nr. 1612/68 af 15. oktober 1968 om arbejdskraftens frie bevaegelighed inden for Faellesskabet (1) udoever eller agter at udoeve en af de i artikel 1 i direktiv 85/433/EOEF omhandlede former for virksomhed som loenmodtager.

1. Member States shall take the measures necessary to comply with this Directive before 1 October 1987. They shall forthwith inform the Commission thereof.

Artikel 5

2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

1. Medlemsstaterne traeffer de noedvendige foranstaltninger for at efterkomme dette direktiv inden den 1. oktober 1987. De underetter straks Kommissionen herom.

Article 6

2. Medlemsstaterne meddeler Kommissionen teksten til de vigtigste nationale retsforskrifter, som de udsteder paa det omraade, der er omfattet af dette direktiv.

Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Pharmaceutical Committee set up by Council Decision 75/320/EEC (2).

Artikel 6

Where necessary, the Commission shall submit appropriate proposals to the Council.

Saafremt der ved gennemfoerelsen af dette direktiv skulle opstaa stoerre vanskeligheder for en medlemsstat paa bestemte omraader, undersoeger Kommissionen disse vanskeligheder i samarbejde med denne stat og indhenter udtalelse fra Laegemiddeludvalget, der er nedsat ved Raadets afgoerelse 75/320/EOEF (2).

Article 7

Kommissionen forelaegger i givet fald passende forslag for Raadet.

This Directive is addressed to the Member States.

Artikel 7

Done at Luxembourg, 16 September 1985.

Dette direktiv er rettet til medlemsstaterne.

For the Council

Udfaerdiget i Luxembourg, den 16. september 1985.

The President

Paa Raadets vegne

M. FISCHBACH

M. FISCHBACH

(1) OJ No C 35, 18. 2. 1981, p. 3.

Formand

(2) OJ No C 277, 17. 10. 1983, p. 160.

(1) EFT nr. C 35 af 18. 2. 1981, s. 3.

(3) OJ No C 230, 10. 9. 1981, p. 10.

(2) EFT nr. C 277 af 17. 10. 1983, s. 160.

(4) See page 37 of this Official Journal.

(3) EFT nr. C 230 af 10. 9. 1981, s. 10.

(1) OJ No L 257, 19. 10. 1968, p. 2.

(4) Se side 37 i denne Tidende.

(2) OJ No L 147, 9. 6. 1975, p. 23.

(1) EFT nr. L 257 af 19. 10. 1968, s. 2.

(2) EFT nr. L 147 af 9. 6. 1975, s. 23.