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 (Consolidated) requires
This directive establishes the comprehensive EU regulatory framework for medicinal products for human use, mandating that no product can be placed on the market without a valid Marketing Authorisation (Article 6). It defines the requirements for authorisation, data exclusivity (the '8+2+1' rule under Article 10), manufacturing, labelling, pharmacovigilance, and advertising.
Pillar: Medical & Healthcare · Authority: The European Parliament and 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:32001L0083
SHA-256 integrity: b97bd575c9e2cc1593036ab75a6ca46a2b80917de04810b4246795c1fb6fd12a
Primary Citations — 7 traced to source
- Directive 2001/83/EC, Article 6: Placing on the market
- Directive 2001/83/EC, Article 8: Particulars and documents which shall accompany an application for marketing authorisation
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