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Image header Agence Europe
Europe Daily Bulletin No. 8236
Contents Publication in full By article 14 / 37
GENERAL NEWS / (eu) eu/health

Commission proposes harmonisation of quality and safety criteria for therapeutic use of human cells and tissue

Brussels, 19/06/2002 (Agence Europe) - As we had announced earlier (see EUROPE of 9 February), the European Commission adopted, on Wednesday, a proposal of directive providing for quality and safety norms for human cells and tissues intended for transplant. The text pursues the same objectives that the directive on blood and blood components which should be amended in just a few days after the Health Council, to be held in Luxembourg on 26 June. It is a matter of ensuring a high level of quality and safety, during the taking of samples, storage, processing and distribution of such products which include skin, cornea and muscle. The only exclusions are blood and its components, already covered by the 2001 directive, tissue or cells intended for self-grafting and organs. In addition to the quality norms and other requirements that should be met by tissue banks, the proposal provides for: - the establishment of a network of registers of national tissue banks; - inspection and control measures to be set in place by the Member States; - application of the same norms to imported or exported products; - guarantees of traceability; - a system for notifying incidents and undesirable effects; - rules of consent and confidentiality for the protection of donors; - and the promotion by Member States of voluntary and unpaid donations.

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