Judgment of the General Court of 14 December 2011 - Nycomed Danmark v EMA

(Case T-52/09) 

(Medicinal products for human use - Authorisation to place a medicinal product on the market - Regulation (EC) No 1901/2006 - Application for a waiver from the obligation to submit a paediatric investigation plan − Rejection by the EMA − Misuse of powers)

Language of the case: English

Parties

Applicant: Nycomed Denmark ApS (Roskilde, Denmark) (represented: initially by C. Schoonderbeek and H. Speyart van Woerden, lawyers, and subsequently by C. Schoonderbeek)

Defendant: European Medicines Agency (EMA) (represented by: V. Salvatore and N. Rampal Olmedo, Agents)

Interveners in support of the defendant: Portuguese Republic (represented by L. Inez Fernandes and P. Antunes, Agents); Kingdom of Belgium, (represented by T. Materne and C. Pochet, Agents); United Kingdom of Great Britain and Northern Ireland (represented by S. Ossowski and H. Walker, Agents, and by J. Stratford, Barrister); French Republic (represented by G. de Bergues, A. Adam, R. Loosli Surrans and J.-S. Pilczer, Agents); and European Commission (represented by P. Oliver and M. Šimerdová, Agents)

Re:

Application for annulment of the decision of the European Medicines Agency (EMA) of 28 November 2008 rejecting the applicant's application for a specific waiver with respect to perflubutane in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council, as amended.

Operative part of the judgment

The Court:

Dismisses the action;

Orders Nycomed Danmark ApS to bear its own costs and those of the European Medicines Agency (EMA), including those relating to the proceedings for interim measures;

Orders the Portuguese Republic, the Kingdom of Belgium, the United Kingdom of Great Britain and Northern Ireland, the French Republic and the European Commission to bear their own costs, including those relating to the proceedings for interim measures.

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¹ - OJ C 82, 4.4.2009.