CELEX: 62009CJ0013
Failure of a Member State to fulfil its obligations
Directive 2006/86/EC
Traceability requirements
Notification of serious adverse reactions and events
Technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
Failure to adopt within the prescribed period

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
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.