CELEX: 62011CA0145
Language: en
Date: 2012-07-19 00:00:00
Title: Case C-145/11: Judgment of the Court (Third Chamber) of 19 July 2012 — European Commission v French Republic (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)

29.9.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 295/10
            
         Judgment of the Court (Third Chamber) of 19 July 2012 — European Commission v French Republic
   (Case C-145/11) (1)
   
   (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
   
      Parties
   
   
      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)
   
      Re:
   
   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
   
      Operative part of the judgment
   
   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.
            
         
      (1)  OJ C 160, 28.5.2011.