CELEX: 62008CJ0385
Failure of a Member State to fulfil obligations
Accession of new Member States
Marketing authorisations for medicinal products that are generics of the reference product Plavix
Conditional decisions authorising the marketing of pharmaceutical products
Infringement of the acquis

Failure of a Member State to fulfil obligations – Infringement of Article 6(1) of 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 2001 L 311, p.
67), read in conjunction with Article 13(4) of 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 1993 L 214, p. 1) and with Articles 89 and 90 of 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) – Marketing authorisations for medicinal products that are generics of the reference product Plavix, in breach of the
10-year period of protection enjoyed by the latter – Conditional decisions authorising the marketing of pharmaceutical products,
issued before the date of Poland’s accession to the European Union but not becoming effective until after that date – Decisions
inconsistent with the provisions of Directive 2001/83/EC.
Operative part
The Court:
1.
Declares that,
–        by retaining in force the decisions of the Minister for Health concerning marketing authorisations for medicinal products
that are generics of the reference product Plavix, and
–        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 of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use,
the Republic of Poland has failed to fulfil its obligations, as regards the first indent above, under Article 6(1) of Directive
2001/83, in conjunction with Article 13(4) of 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 and with Articles 89 and 90 of 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 and, as regards the second indent above, under Article
6(1) of Directive 2001/83;
2.
Orders the Republic of Poland to pay the costs;
3.
Orders the Republic of Lithuania to bear its own costs.