EU Medicinal Products for Human Use Directive 2001/83/EC

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: 2022-01-13

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0083

SHA-256 integrity: e53a394da7adafb4e5ab05ce92f0dfac8ea9cc1b8b0cbb9c44249f24db0cf6d1

Primary Citations — 6 traced to source

• {"title":"Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0083","section":"Articles 1, 6-11, 23, 40, 48-52, 63, 71-75, 101-108a, Annex I (CTD dossier requirements)","relevance":"Primary EU pharmaceutical legislation establishing mandatory marketing authorisation requirement, SmPC/PIL content requirements, prescription/OTC classification, GMP manufacturing obligations, qualified person responsibilities, pharmacovigilance framework, and data/market exclusivity periods"}
• {"title":"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","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R0726","section":"Articles 3-9, 14, 16, 21, 57","relevance":"Establishes the centralised procedure and EMA mandate; defines mandatory centralised scope, CHMP assessment procedures, re-examination rights, EudraVigilance pharmacovigilance database, and EMA's role in PASS/PAES post-authorisation study oversight"}

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