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Action brought on 11 February 2009 - Nycomed Danmark v EMEA

(Case T-52/09)

Language of the case: English

Parties

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

Defendant: European Medicines Agency

Form of order sought

annul the contested decision;

order the EMEA to pay its own costs and those of Nycomed.

Pleas in law and main arguments

By means of the present application, the applicant seeks the annulment, pursuant to Article 230 EC and to Article 73a of Regulation (EC) No 726/2004¹, as amended by Regulation (EC) No 1901/2006² of the European Parliament and of the Council, of the decision "EMEA-000194-IPI01-07" of 28 November 2008 of the European Medicines Agency ("EMEA") rejecting its application for a product specific waiver provided for in Article 11(1)(b) of the aforementioned regulation.

The applicant applied for such a waiver in respect of an ultrasound echocardiographic imaging agent to be marketed under the brand name Imagify, intended to diagnose coronary artery disease ("CAD") in adults. Through its contested decision, the EMEA denied that waiver to the applicants on the grounds that the disease or condition for which the medicinal product is intended is not CAD but myocardial perfusion defects, which also occur in children.

The applicant claims that the contested decision is unlawful in that it is based on an interpretation and application of the concept of "disease or condition for which the medicinal product is intended" within the meaning of Article 11(1)(b) of Regulation (EC) No 1901/2006 which according to the applicant is incorrect in that it does not take into account the therapeutic indication applied for in the concomitant Community market authorisation application and that myocardial perfusion defects are not a disease or condition, but a sign of various diseases.

The applicant further submits that the contested decision is unlawful in that it is an attempt by the EMEA to misuse its powers pursuant to Articles 11(1)(b) and 25 of Regulation (EC) No 1901/2006 in order to attain the aim which is not contemplated by those provisions, namely, the obligation to propose a paediatric investigation plan for indications which are not covered by the concomitant Community market authorisation application.

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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 (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 2006 L 378, p. 1)