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2000/0323(COD)

Human Blood and Blood Components Quality and Safety Directive

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC

Stage
In force, reached 8 Feb 2003
In force
In force since 8 Feb 2003 · CELEX 32002L0098
Transposition deadline
8 Feb 2005
Procedure
Directive · Ordinary legislative procedure
Last activity
8 Feb 2003

Summary

Generated

Directive 2002/98/EC sets quality and safety standards for collecting, testing, processing, storing and distributing human blood and blood components. It covers blood establishments and hospital blood banks, requiring designation or licensing, a quality system, traceability from donor to recipient, and haemovigilance reporting. Member States had to transpose it by 8 February 2005. It is in force.

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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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