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Valentina R., lawyer
(Case C-145/11) (<span class="super">1</span>)
(Failure of a Member State to fulfil obligations - Directive 2001/82/EC - Veterinary medicinal products - Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States - Generic medicinal products similar to the reference medicinal products already authorised - Refusal to approve request by a Member State - Composition and form of the medicinal product)
2012/C 295/16
Language of the case: French
Applicant: European Commission (represented by: M. Šimerdová, A. Marghelis and O. Beynet, Agents)
Defendant: French Republic (represented by: G. de Bergues, S. Menez and R. Loosli-Surrans, Agents)
Failure of a Member State to fulfil obligations — Infringement of Articles 32 and 33 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1) — Decentralised procedure for the grant of marketing authorisation in more than one Member State — Generic medicinal products similar to the reference medicinal products already authorised — Member State’s refusal to approve based on scientific grounds related to the composition of the medicinal product and the choice of pharmaceutical form — Principle of mutual recognition
The Court:
1.Declares that, by refusing to approve two requests for marketing authorisation of the medicinal veterinary products CT-Line 15 % Premix and CT-Line 15 % Oral Powder in the context of the decentralised procedure provided for by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Directive 2004/28/EC of the European Parliament of the Council of 31 March 2004, the French Republic has failed to fulfil its obligations under Articles 32 and 33 of that directive;
2.Orders the French Republic to pay the costs.
(<span class="super">1</span>) OJ C 160, 28.5.2011.