TITLE IIIFREEDOM OF ESTABLISHMENT

CHAPTER IIIRecognition on the basis of coordination of minimum training conditions

Section 7Pharmacist

Article 44Training as a pharmacist

1.Admission to a course of training as a pharmacist shall be contingent upon possession of a diploma or certificate giving access, in a Member State, to the studies in question, at universities or higher institutes of a level recognised as equivalent.

2.Evidence of formal qualifications as a pharmacist shall attest to training of at least five years' duration, including at least:

(a)four years of full-time theoretical and practical training at a university or at a higher institute of a level recognised as equivalent, or under the supervision of a university;

(b)six-month traineeship in a pharmacy which is open to the public or in a hospital, under the supervision of that hospital's pharmaceutical department.

That training cycle shall include at least the programme described in Annex V, point 5.6.1. The contents listed in Annex V, point 5.6.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting them to scientific and technical progress.

Such updates must not entail, for any Member State, any amendment of existing legislative principles relating to the structure of professions as regards training and the conditions of access by natural persons.

3.Training for pharmacists shall provide an assurance that the person concerned has acquired the following knowledge and skills:

(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, and of the use of medicinal products;

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

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

Article 45Pursuit of the professional activities of a pharmacist

1.For the purposes of this Directive, the activities of a pharmacist are those, access to which and pursuit of which are contingent, in one or more Member States, upon professional qualifications and which are open to holders of evidence of formal qualifications of the types listed in Annex V, point 5.6.2.

2.The Member States shall ensure that the holders of evidence of formal qualifications in pharmacy at university level or a level deemed to be equivalent, which satisfies the provisions of Article 44, are able to gain access to and pursue at least the following activities, subject to the requirement, where appropriate, of supplementary professional experience:

(a)preparation of the pharmaceutical form of medicinal products;

(b)manufacture and testing of medicinal products;

(c)testing of medicinal products in a laboratory for the testing of medicinal products;

(d)storage, preservation and distribution of medicinal products at the wholesale stage;

(e)preparation, testing, storage and supply of medicinal products in pharmacies open to the public;

(f)preparation, testing, storage and dispensing of medicinal products in hospitals;

(g)provision of information and advice on medicinal products.

3.If a Member State makes access to or pursuit of one of the activities of a pharmacist contingent upon supplementary professional experience, in addition to possession of evidence of formal qualifications referred to in Annex V, point 5.6.2, that Member State shall recognise as sufficient proof in this regard a certificate issued by the competent authorities in the home Member State stating that the person concerned has been engaged in those activities in the home Member State for a similar period.

4.The recognition referred to in paragraph 3 shall not apply with regard to the two-year period of professional experience required by the Grand Duchy of Luxembourg for the grant of a State public pharmacy concession.

5.If, on 16 September 1985, a Member State had a competitive examination in place designed to select from among the holders referred to in paragraph 2, those who are to be authorised to become owners of new pharmacies whose creation has been decided on as part of a national system of geographical division, that Member State may, by way of derogation from paragraph 1, proceed with that examination and require nationals of Member States who possess evidence of formal qualifications as a pharmacist referred to in Annex V, point 5.6.2 or who benefit from the provisions of Article 23 to take part in it.