Directive 2004/23/EC of the European Parliament and of the CouncilDangos y teitl llawn

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

CHAPTER VU.K.EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 25U.K.Coding of information

1.Member States shall establish a system for the identification of human tissues and cells, in order to ensure the traceability of all human tissues and cells pursuant to Article 8.

2.The Commission, in cooperation with the Member States, shall design a single European coding system to provide information on the main characteristics and properties of tissues and cells.

Article 26U.K.Reports

1.Member States shall send the Commission, before 7 April 2009 and every three years thereafter, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the measures taken in relation to inspection and control.

2.The Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions the reports submitted by the Member States on experience gained in implementing this Directive.

3.Before 7 April 2008 and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the requirements of this Directive, in particular as regards inspection and monitoring.

Article 27U.K.Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 7 April 2006 and shall notify it without delay of any subsequent amendments affecting them.