What EU Medicinal Products for Human Use Directive 2001/83/EC requires
Directive 2001/83/EC, as the core EU pharmaceutical legislation, requires a marketing authorisation (MA) for all medicinal products for human use before they may be placed on the EU market, establishes Good Manufacturing Practice obligations, mandates pharmacovigilance including periodic safety update reports and risk management plans, and creates an 8+2+1 year data and market exclusivity framework for innovative medicines.
Pillar: Pharmaceuticals & Life Sciences · Authority: 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: a06cbcf72166360c25f6bebaac84b49f0139a5581b57a5a749a2cee0d41db563
Primary Citations — 6 traced to source
- Articles 1, 6-11, 23, 40, 48-52, 63, 71-75, 101-108a, Annex I (CTD dossier requirements) — Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
- Articles 3-9, 14, 16, 21, 57 — Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use
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