Official Journal of the European Union

C 313/4

(Case C-452/06)

(Community code relating to medicinal products for human use - Marketing authorisation - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Grounds for refusal - Liability of a Member State - Serious breach of Community law)

(2008/C 313/05)

Language of the case: English

Referring court

Parties to the main proceedings

Applicant: Synthon BV

Defendant: Licensing Authority of the Department of Health

Interested party: SmithKline Beecham plc

Re:

Reference for a preliminary ruling — High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court) — Interpretation of Articles 8, 10(1)(a)(iii) and 28 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) — Abridged procedure for obtaining marketing authorisation — Proprietary medicinal product ‘essentially similar’ to an authorised product — Refusal to accept an application for recognition of marketing authorisation for a medicinal product granted by another Member State — Obligation to recognise the authorisation granted by the reference Member State, except where the procedure laid down by the directive for examining whether there exists a risk to public health is invoked — Sufficiently serious breach of Community law giving rise to an obligation to redress the damage caused

Operative part of the judgment

1.Article 28 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use precludes a Member State to which an application is made for mutual recognition of a marketing authorisation of a medicinal product for human use granted by another Member State under the abridged procedure provided for in Article 10(1)(a)(iii) of that directive from refusing that application on the ground that the medicinal product in question is not essentially similar to the reference product;

2.The failure on the part of a Member State to recognise, pursuant to Article 28 of Directive 2001/83, a marketing authorisation of a medicinal product for human use granted by another Member State under the abridged procedure provided for in Article 10(1)(a)(iii) of that directive, on the ground that the relevant medicinal product either is not essentially similar to the reference product or belongs to a category of medicinal products for which the Member State concerned has a general policy which does not allow it to be considered as essentially similar, constitutes a sufficiently serious breach of Community law, capable of rendering that Member State liable in damages.

(1) OJ C 326, 30.12.2006.