1985L0432 — EN — 31.07.2001 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 16September 1985
concerning the coordination of provisions laid down by law, regulation or administrative action in
respect of certain activities in the field of pharmacy
(85/432/EEC)
(OJ L 253, 24.9.1985, p. 34)
Amended by:
Official Journal
No page date
►M1 Directive 2001/19/EC of the European Parliament and of the Council of
14 May 2001 L 206 1 31.7.2001
▼B
COUNCIL DIRECTIVE
of 16September 1985
concerning the coordination of provisions laid down by law,
regulation or administrative action in respect of certain activities
in the field of pharmacy
(85/432/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 49 and 57 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas persons who hold a diploma, certificate or other formal
qualification in pharmacy are for that reason specialists in the field ofmedicinal 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 limitingthe activities accessible in the Member States to pharmacists, inparticular with regard to medical biology analyses, and does not givethem any monopoly, since the creation of a monopoly continues to be amatter for the Member States alone;
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 andthe monopoly of the supply of medicinal products continue to be mattersfor the Member States;
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 1985concerning the mutual recognition of diplomas, certificates and otherevidence of formal qualifications in pharmacy, including measures tofacilitate the effective exercise of the right of establishment relating tocertain 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 regardsteaching;
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 maysubject thereto nationals of Member States who hold one of the diplomasreferred to in Article 4 of Directive 85/433/EEC;
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 whoare self-employed; whereas, for this reason, it appears necessary toextend the application of this Directive to employed professionalpersons;
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, certificates1985L0432 — EN — 31.07.2001 — 001.001 — 2
(1) OJ No C 35, 18. 2. 1981, p. 3.
(2) OJ No C 277, 17. 10. 1983, p. 160.
(3) OJ No C 230, 10. 9. 1981, p. 10.
(4) See page 37 of this Official Journal.
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and other evidence of formal qualifications in pharmacy specialities and
in order to put all members of the profession who are nationals of theMember 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 toseveral Member States which can entitle a person to use a specialist title,without such training being a condition of access to the activitiesincluded 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 relevantmutual recognition,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. Member States shall ensure that holders of a diploma, certificate or
other university or equivalent qualification in pharmacy which meets theconditions laid down in Article 2 shall be entitled at least to access to theactivities mentioned in paragraph 2 and to pursue such activities subject,where appropriate, to the requirement of additional professionalexperience.
2. The activities referred to in paragraph 1 are:
— the preparation of the pharmaceutical form of medicinal products,
— the manufacture and testing of medicinal products,
— the testing of medicinal products in a laboratory for the of medicinal
of medicinal products,
— the storage, preservation and distribution of medicinal products at the
wholesale stage,
— the preparation, testing, storage and supply of medicinal products in
pharmacies open to the public,
— the preparation, testing, storage and dispensing of medicinal products
in hospitals,
— the provisions of information and advice on medicinal products.
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 ofselecting from among the holders referred to in paragraph 1 those to beappointed to control the new pharmacies to be set up under a nationalgeographical 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, certificatesand other formal qualifications in pharmacy referred to in Article 2 (1)and Article 6 of Directive 85/433/EEC to take part in such acompetition.
Article 2
Member States shall subordinate the award of the diplomas, certificates
and other formal qualifications referred to in Article 1 to the following
minimum conditions:
1. Training leading to the award of the diploma, certificate or other
formal qualification shall ensure:
(a) adequate knowledge of medicines and the substances used in the
manufacture of medicines;
(b) adequate knowledge of pharmaceutical technology and the
physical, chemical, biological and microbiological testing of
medicinal products;
(c) adequate knowledge of the metabolism and the effects of
medicinal products and of the action of toxic substances, andof the use of medicinal products;
(d) adequate knowledge to evaluate scientific data concerning
medicines in order to be able to supply appropriate informationon the basis of this knowledge;1985L0432 — EN — 31.07.2001 — 001.001 — 3
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(e) adequate knowledge of the legal and other requirements
associated with the practice of pharmacy.
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.
3. The diploma, certificate or other formal qualification shall testify to
the completion of a course of training covering a period of at leastfive years and comprising:
— at least four years of full-time theoretical and practical training in
a university, in a higher education institution of a level recognizedas having equivalent status, or under the supervision of auniversity,
— at least six months of in-service training in a pharmacy open to
the public or in a hospital under the supervision of thepharamaceutical department of that hospital.
4. By way of derogation from point 3:
(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 courseof training, shall be considered to fulfil the condition concerningduration referred to in point 3 provided that the diplomas,certificates or other formal qualifications testifying to thecompletion of the two courses of training are recognized as
equivalent by that State;
(b) if, because, there are insufficient places in pharmacies open to the
public and in hospitals near training establishments, a MemberState is unable to provide six months of in-service training, itmay, for a period of five years following the expiry of the timelimit laid down in Article 5, make provision for no more than halfof that training period to involve activities as a pharmacist in an
undertaking which manufactures medicinal products.
5. The course of training referred to in point 3 shall comprise as a
minimum theoretical and practical training in the following subjects:
— Plant and animal biology,
— Physics,
— General and inorganic chemistry,— Organic chemistry,— Analytical chemistry,
— Pharmaceutical chemistry, including analysis of medicinal
products,
— General and applied biochemistry (medical),— Anatomy and physiology; medical terminology,
— Microbiology,
— Pharmacology and pharmacotherapy,— Pharmaceutical technology,— Toxicology,— Pharmacognosy,
— Legislation and, where appropriate, professional ethics.
The balance between theoretical and practical training shall, in
respect of each subject, give sufficient importance to theory tomaintain the university character of the training.
6. As a transitional measure and by way of derogation from paragraphs
3 and 5, Italy, whose laws, regulations and administrative provisions
prescribed training which was not brought fully into line with thetraining requirements laid down in this Article by the deadlinestipulated in Article 5, may continue to apply those provisions topersons who commenced their training in pharmacy before 1November 1993 and concluded it before 1 November 2003.1985L0432 — EN — 31.07.2001 — 001.001 — 4
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▼M1
Each host Member State shall be authorised to require that holders of
diplomas, certificates and other evidence of formal qualifications inpharmacy awarded in Italy on completion of training commenced
before 1 November 1993 and concluded before 1 November 2003
produce, together with their qualifications, a certificate stating that,for at least three consecutive years during the five years prior to theissue of the certificate, they were effectively and lawfully engaged inone of the activities referred to in Article 1(2) in so far as such
activity is regulated in Italy.
Article 3
Not more than three years after the expiry of the time limit laid down in
Article 5, the Commission shall submit to the Council appropriateproposals on specializations in pharmacy and in particular hospital
pharmacy. The Council shall examine these proposals within one year.
Article 4
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 activitiesreferred to in Article 1 of Directive 85/433/EEC.
Article 5
1. Member States shall take the measures necessary to comply with
this Directive before 1 October 1987. They shall forthwith inform theCommission thereof.
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.
Article 6
Where a Member State encounters major difficulties in certain fields
when applying this Directive, the Commission shall examine thesedifficulties in conjunction with that State and shall request the opinion ofthe Pharmaceutical Committee set up by Council Decision 75/320/EEC (
2).
Where necessary, the Commission shall submit appropriate proposals to
the Council.
Article 7
This Directive is addressed to the Member States.1985L0432 — EN — 31.07.2001 — 001.001 — 5
(1) OJ No L 257, 19. 10. 1968, p. 2.
(2) OJ No L 147, 9. 6. 1975, p. 23.▼B