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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC · European Union

Blood establishments shall designate a person (responsible person), responsible for: ensuring that every unit of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for transfusion, in compliance with the laws in force in the Member State, providing information to the competent authority in the designation, authorisation, accreditation or licensing procedures as required in Article 5, the implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in the blood establishment.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.