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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 10 CELEX: 02004L0023-20090807 Register of tissue establishments and reporting obligations
1. Tissue establishments shall keep a record of their activities, including the types and quantities of tissues and/or cells procured, tested, preserved, processed, stored and distributed, or otherwise disposed of, and on the origin and destination of the tissues and cells intended for human applications, in accordance with the requirements referred to in Article 28(f). They shall submit to the competent authority or authorities an annual report on these activities. This report shall be publicly accessible. 2. The competent authority or authorities shall establish and maintain a publicly accessible register of tissue establishments specifying the activities for which they have been accredited, designated, authorised or licensed. 3. Member States and the Commission shall establish a network linking the national tissue establishment registers. |