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…
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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: d30107cbb6283a11f20abef25e57b3eafec49de8463f717ea6be4146da0b4447
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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