27 September 2007 (*1)

(Failure of a Member State to fulfil obligations – Directive 2004/27/EC – Medicinal products for human use – Failure to transpose into national law within the prescribed period)

In Case C‑66/07,

ACTION under Article 226 EC for failure to fulfil obligations, brought on 8 February 2007,

Commission of the European Communities, represented by B. Stromsky and D. Lawunmi, acting as Agents, with an address for service in Luxembourg,

applicant,

Ireland, represented by D. O’Hagan, acting as Agent, with an address for service in Luxembourg,

defendant,

THE COURT (Seventh Chamber),

composed of J. Klučka, President of Chamber, J.N. Cunha Rodrigues (Rapporteur) and U. Lõhmus, Judges,

Advocate General: Y. Bot,

Registrar: R. Grass,

having regard to the written procedure,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

1By its application, the Commission of the European Communities seeks a declaration from the Court that, by not adopting the laws, regulations and administrative provisions necessary to comply with Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34), or, in any case, by not communicating those measures to the Commission, Ireland has failed to fulfil its obligations under that directive.

2Under Article 3 of Directive 2004/27:

‘Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 October 2005. They shall immediately inform the Commission thereof.

3On receiving no notification of the measures transposing Directive 2004/27 into Irish law, the Commission initiated the infringement procedure under Article 226 EC. After giving Ireland formal notice to submit its observations, the Commission delivered a reasoned opinion on 4 July 2006, calling on Ireland to take the measures necessary to comply with that opinion within two months of receiving it.

4In its reply of 27 July 2006 to the reasoned opinion, Ireland informed the Commission that the procedure for transposing Directive 2004/27 into national law had reached an advanced stage.

5When, subsequently, it received no further information, the Commission decided to bring the present action.

The action

6Ireland does not dispute the infringement imputed to it. Ireland merely points out that the adoption of the draft regulations which have already been prepared will enable Directive 2004/27 to be transposed into national law.

7According to settled case-law, the question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion (see, inter alia, Case C‑143/02 Commission v Italy [2003] ECR I‑2877, paragraph 11).

8Since, on expiry of the period laid down in the reasoned opinion, Ireland had not adopted the measures necessary to ensure the transposition of Directive 2004/27 into national law, the action brought by the Commission must be regarded as well founded.

9It is therefore appropriate to state that, by not adopting within the prescribed period the laws, regulations and administrative provisions necessary to comply with Directive 2004/27, Ireland has failed to fulfil its obligations under that directive.

Costs

10Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs, if they have been applied for in the successful party’s pleadings. Since the Commission applied for costs and Ireland has been unsuccessful in its pleadings, the latter must be ordered to pay the costs.

On those grounds, the Court (Seventh Chamber) hereby:

1. Declares that, by not adopting within the prescribed period the laws, regulations and administrative provisions necessary to comply with Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Ireland has failed to fulfil its obligations under that directive;

[Signatures]

*

Language of the case: English.