TITLE III

FREEDOM OF ESTABLISHMENT
CHAPTER III

Recognition on the basis of coordination of minimum training conditions
Section 7

Pharmacist

Pursuit of the professional activities of a pharmacist
Article 45
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 recognised as equivalent, which satisfies the requirements 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
supply, preparation, testing, storage, distribution and dispensing of safe and efficacious medicinal products of the required quality in pharmacies open to the public;
f
preparation, testing, storage and dispensing of safe and efficacious medicinal products of the required quality in hospitals;
g
provision of information and advice on medicinal products as such, including on their appropriate use;
h
reporting of adverse reactions of pharmaceutical products to the competent authorities;
i
personalised support for patients who administer their medication;
j
contribution to local or national public health campaigns.
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.
Substituted by Directive 2013/55/EU of the European Parliament and of the Council of 20 November 2013 amending Directive 2005/36/EC on the recognition of professional qualifications and Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System (‘the IMI Regulation’) (Text with EEA relevance).