COMMISSION DECISION
of 3 August 2010
establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council
(notified under document C(2010) 5278)
(Text with EEA relevance)
(2010/453/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty of the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 7(5) thereof,
Whereas:
(1)
Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications only as far as donation, procurement and testing are concerned, so as to ensure a high level of human health protection.
(2)
In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Article 7 of Directive 2004/23/EC provides that competent authorities of the Member States shall organise inspections and shall carry out appropriate control measures in order to ensure compliance with the requirements of this Directive.
(3)
Article 7(5) of Directive 2004/23/EC provides that the Commission shall establish guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of the officials involved in order to reach a consistent level of competence and performance. The guidelines are not legally binding but serve to provide useful guidance to the Member States in the implementation of Article 7 of Directive 2004/23/EC.
(4)
The Commission should review and update the guidelines set out in the Annex to this Decision on the basis of the reports transmitted by the Member States to the Commission in accordance with Article 26(1) of Directive 2004/23/EC.
(5)
The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 29 of Directive 2004/23/EC,
HAS ADOPTED THIS DECISION:
Article 1
The guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Article 7(5) of Directive 2004/23/EC are set out in the Annex to this Decision.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 3 August 2010.