27.9.2008   

EN

Official Journal of the European Union

C 247/9

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declare that, by retaining in force the national authorisation for the marketing of the medicinal product ‘Grasalva’, the Republic of Lithuania has failed to meet its obligations under Article 6(1) of and Section 4 of Part II of Annex I to Directive 2001/83/EC (1), as amended by Directive 2003/63/EC (2), under Article 3(1) of Regulation (EEC) No 2309/93 (3) and under Article 3(1) of Regulation (EC) No 726/2004 (4);

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order the Republic of Lithuania to pay the costs.

(i)

The Republic of Lithuania is required, under Article 6(1) of Directive 2001/83/EC, to examine whether marketing authorisations issued prior to accession comply with the requirements of the Community legislation on pharmaceutical products in force at the time of accession and, as from 1 May 2004, to ensure that only medicinal products the authorisations for which comply with those requirements are placed on the market.

(ii)

The medicinal product ‘Grasalva’ is not mentioned in Appendix A to Annex IX to the 2003 Act of Accession and for that reason the provisions relating to the transitional period cannot be applied to it and, as from 1 May 2004, this medicinal product could be marketed only if it complied with all of the Community-law requirements in force for similar biological medicinal products with regard to quality, safety and efficacy, in particular those laid down in Section 4 of Part II of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC.

(iii)

The competent institutions of the Republic of Lithuania have themselves established that the documents relating to the medicinal product ‘Grasalva’ do not contain any information concerning pre-clinical or clinical trials provided in accordance with Section 4 of Part II of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, concerning compliance by the medicinal product ‘Grasalva’ with the safety and efficacy requirements applied to similar biological medicinal products.

(iv)

The national marketing authorisation for the medicinal product ‘Grasalva’ fails to meet the requirements of Section 4 of Part II of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, with the result that, as from the date of accession, that medicinal product could be placed on the market only if marketing authorisation for it had been granted centrally pursuant to Article 3(1) of Regulation (EEC) No 2309/93 (applied up to 20 November 2005) or Article 3(1) of Regulation (EC) No 726/2004 (applicable from 21 November 2005).