18.8.2012

EN

Official Journal of the European Union

C 250/20

(Case T-301/12)

2012/C 250/36

Language of the case: English

Parties

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

Defendant: European Commission

Form of order sought

—Annul Commission Decision of 25 May 2012 refusing a marketing authorisation for ‘Orphacol — Cholic acid’;

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

Pleas in law and main arguments

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

1.First plea in law, alleging that the contested decision infringes both Regulation (EU) No 182/2011 (1) and Regulation (EC) No 726/2004 (2) because the Commission was not entitled to re-initiate the Comitology Procedure with a draft decision substantively the same as the version already rejected by the Standing Committee and Appeal Committee, nor was it empowered to adopt the contested decision.

2.Second plea in law, alleging that the contested decision is in any event vitiated by fundamental errors of law in the interpretation of Directive 2001/83/EC (as amended) (3).

(1) 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)

(2) 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)

(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)