CELEX: 62007CJ0066
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

By 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.

Legal context and the pre-litigation procedure
Under 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.
...’
On 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.
In 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.
When, subsequently, it received no further information, the Commission decided to bring the present action.

The action
Ireland 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.
According 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).
Since, 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.
It 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
Under 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;
2.
Orders Ireland to pay the costs.
[Signatures]
*
Language of the case: English.