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Case T-264/07: Judgment of the General Court of 9 September 2010 — CSL Behring v Commission and EMA (Medicinal products for human use — Procedure for designation of orphan medicinal products — Application for designation of human fibrinogen as an orphan medicinal product — Obligation to submit the application for designation before the application for marketing authorisation is made — Decision of EMA on the validity of the application)
ECLI:EU:UNKNOWN:62007TA0264
62007TA0264
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23.10.2010
Official Journal of the European Union
C 288/31
(Case T-264/07) (*)
(Medicinal products for human use - Procedure for designation of orphan medicinal products - Application for designation of human fibrinogen as an orphan medicinal product - Obligation to submit the application for designation before the application for marketing authorisation is made - Decision of EMA on the validity of the application)
(2010/C 288/59)
Language of the case: German
Parties
Applicant: CSL Behring GmbH (Marburg, Germany) (represented by: C. Koenig, Professor, and F. Leinen, lawyer)
Defendants: European Commission (represented by: B. Stromsky and B. Schima, Agents) and European Medicines Agency (EMA), (represented by V. Salvatore, Agent, T. Eicke, Barrister and C. Sherliker, Solicitor)
Intervener in support of the defendant European Commission: European Parliament (represented by E. Waldherr and I. Anagnostopoulou, Agents)
Re:
Action for annulment of the decision of 24 May 2007 of the European Medicines Agency (EMA) declaring invalid the applicant’s application for designation of human fibrinogen as an orphan medicinal product within the meaning of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1)
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders CSL Behring GmbH to bear its own costs and to pay those of the European Commission and of the European Medicines Agency (EMA);
3.Orders the European Parliament to bear its own costs.
(*)
Language of the case: German.
(1) OJ C 235, 6.10.2007.