Notice for the OJ

 

Action brought on 14 April 2003 by AGA AB against the Commission of the European Communities

    (Case T-122/03)

    (Language of the case: German)

An action against the Commission of the European Communities was brought before the Court of First Instance of the European Communities on 14 April 2003 by AGA AB, whose registered office is in Lidingö (Sweden), represented by B. Sträter and M. Ambrosius, lawyers.

The applicant claims that the Court should:

(annul the decision of the European Agency for the Evaluation of Medicinal Products of 4 February 2003, Document No EMEA/2044;

(    order the defendant to pay the costs of the proceedings.

Pleas in law and main arguments

The applicant holds a Community marketing authorisation for the medicinal product, INOmax, whose active ingredient is nitrogen oxide (NO). On 25 January 2002, the competent authority in France granted another undertaking a national authorisation for a medicinal product called KINOX, whose active ingredient is also nitrogen oxide. In response to that authorisation, the applicant lodged an application with the European Agency for the Evaluation of Medicinal Products (EMEA) to initiate the procedure under Article 31 of Directive 2001/83/EC ¹ in respect of medicinal products containing nitrogen oxide. That application was rejected in the contested decision on the ground that the applicant, as holder of a Community marketing authorisation, is not entitled to make such an application.

The applicant raises the following pleas in law:

(Infringement of essential procedural requirements. The applicant submits that the contested decision was adopted by staff in the secretariat of the EMEA, who, under the relevant procedural provisions of Directive 2001/83/EC and Regulation No 2309/93/EC ² were not competent to adopt such a decision. Instead, the decision on whether to reject the application should have been taken by the Committee for Proprietary Medicinal Products (CPMP) of the EMEA.

(Failure to observe the principle of the right to be heard, in so far as the applicant was not given any opportunity to express its views on the matter before the decision to reject the application on procedural grounds was adopted.

(Incorrect interpretation of Article 31 of Directive 2001/83/EC. The applicant submits that, contrary to the view of the EMEA, holders of Community marketing authorisations for medicinal products for human use are also entitled to lodge applications on the basis of that article.

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¹ - (OJ L 311 of 28.11.2001, p. 67.

² - (OJ L 214 of 24.08.1993, p. 1.