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Directive 2001/83/EC of the European Parliament and of the… Article 109

Directive 2001/83/EC of the European Parliament and of the… Article 109

Article 109

1. In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products, Member States shall take the necessary measures to prevent the transmission of infectious diseases. In so far as this is covered by the amendments referred to in Article 121(1), as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors. 2. Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable. 3. All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries.

Read the full instrument → · Read this in context: TITLE X — SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA →

Other provisions in TITLE X — SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 109 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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