2002/0128(COD)

Human Tissues and Cells Quality and Safety Directive

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells

Stage: In force, reached 7 Apr 2004
In force: In force since 7 Apr 2004 · CELEX 32004L0023
Transposition deadline: 7 Apr 2006
Procedure: Directive · Ordinary legislative procedure
Last activity: 7 Apr 2004

14 documents

Documents

Newest first. Each opens at its source.

Text adopted · OJ L 294 25.10.2006, p. 0032-0050Commission · 25 Oct 2006
Text adopted · OJ L 038 09.02.2006, p. 0040-0052Commission · 9 Feb 2006
Text adopted · OJ L 102 07.04.2004, p. 0048-0058Commission · 7 Apr 2004
Text adopted · Directive 2004/0023Commission · 31 Mar 2004
OJ C 085 08.04.2003, p. 0044-0050Commission · 8 Apr 2003
Text adopted · 32006L0017Commission
Text adopted · 32006L0086Commission
Report · A5-0103/2003Parliament
Report · A5-0387/2003Parliament
Proposal · COM(2002)0319Commission
Proposal · COM(2016)0223Commission
SEC(2003)0906Commission
Text adopted · T5-0182/2003Parliament
Text adopted · T5-0570/2003Parliament

Summary

Generated

Directive 2004/23/EC sets quality and safety standards for human tissues and cells intended for human applications, covering donation, procurement, testing, processing, preservation, storage and distribution. Member States had to transpose it by 7 April 2006. It requires accreditation of tissue establishments, traceability for at least 30 years, and reporting of serious adverse events.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 6 Oct 2026. Something wrong on this page? Report an error.

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