3. — Directive 2004/23/EC of the European Parliament and of the Council of 31 March…

3.

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 · European Union

The tissue establishment shall not undertake any substantial changes to its activities without the prior written approval of the competent authority or authorities.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.