28.5.2011

Official Journal of the European Union

C 160/12

(Case C-145/11)

2011/C 160/14

Language of the case: French

Parties

Applicant: European Commission (represented by: M. Šimerdová and A. Marghelis, Agents)

Defendant: French Republic

Form of order sought

—declare that, by refusing to approve two applications for marketing authorisations of the veterinary medicinal products CT-Line 15 % Premix and CT-Line 15 % Oral Powder in the context of the decentralised procedure laid down by Directive 2001/82/EC on the Community code relating to veterinary medicinal products, the French Republic has failed to fulfil its obligations under Articles 32 and 33 of that directive;

—order the French Republic to pay the costs.

Pleas in law and main arguments

By the present action, the Commission submits that the abovementioned Directive 2001/82/EC does not allow a Member State, in the context of the decentralised procedure, to carry out a legal and scientific assessment of an application for authorisation. The purpose of the validation phase is merely to verify if the dossier submitted is identical in all the Member States, if it is complete, and if it includes the list of Member States concerned, in accordance with the conditions laid down in Article 32(1) of the directive. The applicant thus criticises the defendant for refusing applications for authorisation by relying inter alia on grounds concerning the composition of the medicinal product and its pharmaceutical form, its alleged non-compliance with national law and the possible dangers to public health.

The Commission also points out that, at the validation stage, the Member States affected by an application for authorisation have the obligation to approve the assessment report submitted by the reference Member State, unless they invoke a serious potential risk to human or animal health or the environment, in compliance with Article 33 of the directive. The French authorities therefore failed to follow the procedure laid down by that article.

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).

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