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

2.

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 competent authority or authorities, having verified that the tissue establishment complies with the requirements referred to in Article 28(a), shall accredit, designate, authorise or license the tissue establishment and indicate which activities it may undertake and which conditions apply. It or they shall authorise the tissue and cell preparation processes which the tissue establishment may carry out in accordance with the requirements referred to in Article 28(g). Agreements between tissue establishments and third parties, as referred to in Article 24, shall be examined within the framework of this procedure.

← 1. · All articles · 3. →

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