The European Parliament and of the Council adopted in March 2004 Directive 2004/23/EC that sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This entered into force on 7 April 2004.
The Directive empowers the Commission to establish and update technical requirements in relation to quality and safety of human Tissues and cells. In anticipation of its responsibilities under this Directive, the Commission is conducting an open consultation on draft technical requirements related to the donation procurement and testing of tissues and cells.
This Open Consultation is the second phase in the process towards a Commission Directive on the technical requirements in the aforementioned areas.
This document is based on the technical annexes adopted by the Commission in the original proposal for the Directive (COM(2002) 0319 final).
The Council and the Parliament decided during the legislative process that the requirements will be developed by comitology. The document incorporates the extensive comments and contributions received from a Commission working group of experts representing the tissues and cells community, including the Council of Europe. Its contribution and other comments received have been edited and reorganised into this Open Consultation document.
These draft technical requirements are for consultation purposes and the Commission invites you to provide comments and to submit them in electronic form by 1 October 2004 to: Eduardo Fernandez-Zincke.
