6.12.2008

EN

Official Journal of the European Union

C 313/12

(Case C-385/08)

(2008/C 313/18)

Language of the case: Polish

Parties

Applicant: Commission of the European Communities (represented by: M. Šimerdová and K. Herrmann, acting as Agents)

Defendant: Republic of Poland

Form of order sought

—declare that, by retaining in force marketing authorisations for medicinal products that are generics of the reference product Plavix, the Republic of Poland has failed to fulfil its obligations under Article 6(1) of Directive 2001/83/EC, in conjunction with Article 13(4) of Regulation (EEC) No 2309/93 and Articles 89 and 90 of Regulation (EC) No 726/2004;

—declare that, by placing and keeping on the market after 1 May 2004 medicinal products whose marketing authorisation was not issued in accordance with Article 6(1) of Directive 2001/83/EC, the Republic of Poland has failed to fulfil its obligations under that article;

—order the Republic of Poland to pay the costs.

Pleas in law and main arguments

In the applicant's view, marketing of the medicinal products which are the subject of decisions of the Minister for Health of the Republic of Poland that were issued in the period from January to April 2004 and contain additional recommendations and requirements for additional investigation cannot be covered by the transitional period laid down in point 1.5 of Annex XII to the Act concerning the conditions of accession of the Republic of Poland to the European Union, because those decisions of the Minister for Health did not constitute before 1 May 2004 marketing authorisations for the purposes of point 1.5 of Annex XII. The medicinal products at issue therefore had to be placed on the market by means of a marketing authorisation issued in accordance with Directive 2001/83/EC or Regulation No 2309/93.

Furthermore, in the applicant's submission the marketing of medicinal products that are generics of the reference product Plavix could not be covered by the transitional period laid down in point 1.5 of Annex XII to the Act concerning the conditions of accession, because the exceptions provided for therein concerned exclusively the requirements of safety, quality and efficacy prescribed in Directive 2001/83/EC, and not the 10-year period of data protection laid down in Article 13(4) of Regulation (EEC) No 2309/93 and Articles 89 and 90 of Regulation (EC) No 726/2004.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ L 214, 24.8.1993, p. 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 L 136, 30.4.2004, p. 1).