Keywords
Subject of the case
Operative part

Keywords

Actions for failure to fulfil obligations – Examination of the merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion (Art. 226 EC) (see para. 9)

2. Member States – Obligations – Implementation of directives – Failure to fulfil obligations – National system pleaded as justification – Not permissible (Art. 226 EC) (see para. 10)

Subject of the case

Re:

Failure of a Member State to fulfil obligations – Failure to adopt, within the prescribed period, the provisions necessary to comply with Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ 2006 L 294, p. 32).

Operative part

Operative part

The Court:

1. Declares that, by failing to adopt within the prescribed period all the laws, regulations and administrative provisions necessary to comply with Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, the Italian Republic has failed to fulfil its obligations under that directive;

2. Orders the Italian Republic to pay the costs.