What Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use requires
This Directive establishes the legal framework for the authorization, manufacturing, labelling, advertising, and pharmacovigilance of medicinal products for human use within the European Union. It applies to all entities placing medicinal products on the EU market and mandates compliance with requirements under Article 67, Article 46, and Annex I, among others.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and of the Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32001L0083
SHA-256 integrity: f5b6a607638ef18d3d17ac5534cddb7d5d580b38d12820e71a46627e665afce2
Primary Citations — 5 traced to source
- Directive 2001/83/EC, Article 67 - Application for marketing authorization
- Directive 2001/83/EC, Article 46 - Principles of Good Manufacturing Practice
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