Article 12

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

Documentation 1. Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms. 2. Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8.

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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.