Keywords
Summary

Keywords

1. Accession of new Member States to the Communities – Czech Republic – Estonia – Cyprus – Latvia – Lithuania – Hungary – Malta – Poland – Slovenia – Slovakia – Community acts adopted after signature of the Treaty of Accession but before its entry into force

(Art. 249 EC; 2003 Act of Accession, Arts 2(2), 10 and 54)

2. Approximation of laws – Medicinal products for human use – Marketing authorisation – Marketing authorisation for a medicinal product granted before accession maintained by a Member State after its accession

(European Parliament and Council Regulation No 726/2004, Art. 3(1); Council Regulation No 2309/93, Art. 3(1); European Parliament and Council Directive 2001/83, modified by Directive 2003/63, Art. 6(1))

Summary

1. Once the 2003 Treaty of Accession to the European Union of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic was signed, and subject to the application of the particular procedures provided for in that Treaty for deciding on certain types of transitional measures, such as, for example, those established by Articles 41 or 42 of the 2003 Act of Accession, there is no objection in principle to secondary legislation adopted after that signature and before the entry into force of the 2003 Treaty of Accession containing temporary derogations in favour of a future Member State being adopted directly on the basis of the provisions of the EC Treaty.

Consequently, as regards measures that must be thus adopted during the period between the date of signature of the Treaty of Accession and the date when the accession takes effect, the institutions are fully aware of the imminent accession of new Member States, and the latter have the opportunity of asserting their interests where necessary, in particular through the information and consultation procedure. It is therefore, in principle, in the framework of that procedure and by making use of their observer status in the Council of the European Union, with the opportunities for dialogue and cooperation which those special mechanisms afford them, that the future Member States may, once informed of the future adoption of new measures of secondary legislation, assert their interest in obtaining the necessary transitional derogations, having regard, for example, to the fact that it would be impossible to ensure immediate application of those measures on accession, or to major socio-economic problems to which such application might give rise.

(see paras 71-73)

2. By maintaining in force, beyond the date of its accession to the European Union, the national marketing authorisation for a medicinal product from biotechnical processes, which was not granted in accordance with the European Union legislation relating to medicinal products in force at that date, a Member State fails to fulfil its obligations under 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), as amended by Commission Directive 2003/63/EC of 25 June 2003 (OJ 2003 L 159, p. 46), and under Article 3(1) 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 under Article 3(1) 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.

It is apparent from Articles 2 and 10 of the Act concerning the conditions of accession to the European Union of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded that the Act is based on the principle that the provisions of European Union law apply ab initio and in toto to new Member States, derogations being allowed only in so far as they are expressly provided for by transitional provisions. With regard to those derogations, Article 24, read in conjunction with Annex IX, Chapter 1, paragraph 2, thereto, provides for a transitional period during which marketing authorisations granted under its national legislation by the Republic of Lithuania, before the date of its accession to the European Union, for pharmaceutical products in the list in Appendix A remained valid even after that date and until 1 January 2007 at the latest. A marketing authorisation granted for a medicinal product not included in the list in Appendix A ought, as from the date of accession, 1 May 2004, have been made consistent with the European Union legislation in force on that date.

It cannot be deduced from the fact that Annex IX, Chapter 1, paragraph 2, of that Act of Accession refers to Directive 2001/83 in the original version that any authorisation consistent with that version could, without the medicinal product in question’s being included in the list in Appendix A, derogate from the requirements laid down in European Union law in force at the date of accession. The same is true even when those requirements have been amended during the period between the date of signature of that Act of Accession and the date on which accession took effect, as was the case of Directive 2001/83, amended by Directive 2003/63 which set as 31 October 2003 the end of the period in which Member States were to transpose that directive.

(see paras 55, 57, 59-60, 63, 65, 76, 90 and operative part)