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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 · European Union

Tissue establishments shall establish written agreements with a third party each time an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, and in particular in the following circumstances: where a tissue establishment entrusts one of the stages of tissue or cell processing to a third party; where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution; where a tissue establishment provides services to a tissue establishment which is not accredited; where a tissue establishment distributes tissue or cells processed by third parties.

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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.