# C_2008247EN.01000902.xml

| 27.9.2008 | EN | Official Journal of the European Union | C 247/9 |
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27.9.2008

EN

Official Journal of the European Union

C 247/9

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Action brought on 29 July 2008 — Commission of the European Communities v Republic of Lithuania

(Case C-350/08)

(2008/C 247/16)

Language of the case: Lithuanian

Parties

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

Applicant:

Defendant: Republic of Lithuania

Defendant:

Form of order sought

| — | 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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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. |
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order the Republic of Lithuania to pay the costs.

Pleas in law and main arguments

| (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. |
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(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. |
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(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. |
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(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). |
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(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).

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(1)  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).

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(2)  Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ 2003 L 159, p. 46).

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(3)  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).

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(4)  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).

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