Subject of the case
Operative part
Subject of the case
Re:
Failure of a Member State to fulfil its obligations – Failure to adopt or communicate, within the prescribed time-limit, the measures 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 not adopting within the period prescribed in the first subparagraph of Article 11(1) of 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 all the laws, regulations and administrative provisions necessary to comply with that directive, the Kingdom of Belgium has failed to fulfil its obligations under that directive;
2. Orders the Kingdom of Belgium to pay the costs.