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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 article 5 CELEX: 02004L0023-20090807 Supervision of human tissue and cell procurement
1. Member States shall ensure that tissue and cell procurement and testing are carried out by persons with appropriate training and experience and that they take place in conditions accredited, designated, authorised or licensed for that purpose by the competent authority or authorities. 2. The competent authority or authorities shall take all necessary measures to ensure that tissue and cell procurement complies with the requirements referred to in Article 28(b), (e) and (f). The tests required for donors shall be carried out by a qualified laboratory accredited, designated, authorised or licensed by the competent authority or authorities. |