25.2.2012

EN

Official Journal of the European Union

C 58/15

(Case T-12/12)

2012/C 58/29

Language of the case: English

Parties

Applicant: Laboratoires CTRS (Boulogne-Billancourt, France) (represented by: K. Bacon, Barrister, M. Utges Manley, Solicitor, and M. Barnden, Solicitor)

Defendant: European Commission

Form of order sought

—Declare, pursuant to Article 265 TFEU, that the defendant has unlawfully failed to act, contrary to Article 10(2) of Regulation (EC) No 726/2004;

—In the alternative, annul the decision of the defendant of 5 December 2011 declining to grant a marketing authorisation under Regulation (EC) No 726/2004; and

—Order the defendant to bear the costs of this application.

Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.

1.First plea in law, alleging, with regard to the action for failure to act lodged pursuant to Article 265 TFEU, that the refusal to adopt a final decision on the application for an authorisation for Orphacol is contrary to the requirements of Article 10(2) of Regulation (EC) No 726/2004.

2.Second plea in law, alleging, with regard to the action of annulment lodged pursuant to Article 263 TFEU in the alternative, that by adopting a decision that was rejected by the Standing Committee and the Appeal Committee under the Comitology Procedure, the defendant is in breach of Regulation (EU) No 182/2011 and Regulation (EC) No 726/2004.

3.Third plea in law, alleging with regard to the action of annulment lodged pursuant to Article 263 TFEU in the alternative, that the decision is in any event vitiated by fundamental errors of law in the interpretation of Directive 2001/83/EC (as amended), and defects of reasoning contrary to Article 296 TFEU.

(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)

(2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13)

(3) 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)