Open Consultation on Draft Technical Requirements for Tissues and cells

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 was adopted in March 2004. This text entered into force on 7 April 2004, the date of its publication in the Official Journal of the European Communities.

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 conducted in June 2005 an open consultation on draft technical requirements related to the coding, processing, preservation, storage and distribution of human tissues and cells.

This Open Consultation was the second phase in the process towards a Commission Directive on the technical requirements in the aforementioned areas. This document reflected the technical annexes adopted by the Commission in the original proposal for the Directive (COM(2002) 0319 final) which Council and Parliament decided during the legislative process to be developed by comitology. In addition the document incorporated the extensive comments and contributions received from a Commission working group of experts representing the tissues and cells community, including the Council of Europe. That contribution and the comments received on it were amalgamated, edited and reorganised into the Open Consultation documentpdf(867 KB) on coding, processing, preservation, storage and distribution of human tissues and cells.

The European Commission thanks all the national and regional authorities, NGOs, individual citizens, companies and associations who participated in this consultation which will feed into the preparation of the future technical requirements.

arrowList of all the contributions received

Directive 2004/23/EC establishing the above requirements