Action brought on 21 January 2014 – Pfizer v Commission and EMA

(Case T-48/14)

Language of the case: English

Parties

Applicant: Pfizer Ltd (Sandwich, United Kingdom) (represented by: K. Bacon and M. Schaefer, Barristers, I. Dodds-Smith, C. Stothers and J. Mulryne, Solicitors)

Defendants: European Commission and European Medicines Agency

Form of order sought

The applicant claims that the Court should:

Annul the decision of the Commission and of EMA contained in the letters of 11 November 2013 and of 15 November 2013 not to issue the compliance statement; and

Order the Commission and EMA to bear the costs of the application.

Pleas in law and main arguments

In support of the action, the applicant relies on one plea in law, alleging that in contending that the compliance statement, for the applicant’s marketing authorisation of medicinal product Vfend, cannot be issued until the studies set out in the paediatric investigation plan (“PIP”) have been assessed for the purposes of the new prophylaxis indication, the EMA has misinterpreted Article 28(3) of the Paediatric Regulation¹ .

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¹ Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, p.1).