What EU Regulation 726/2004 - EMA Centralised Procedure for Marketing Authorisation of Medicinal Products requires
Regulation (EC) No 726/2004 establishes the centralised procedure for European Medicines Agency (EMA) marketing authorisation (MA) of medicines for human and veterinary use. Centralised MAs grant simultaneous marketing rights across all EU/EEA member states. The centralised procedure is mandatory for biotechnology-derived medicines, orphan drugs, advanced therapy medicinal products, and certain new active substances. The 210-day assessment procedure involves CHMP and CAT scientific committees, with a 30-day referral to the European Commission for final decision.
Pillar: Biotech & Genomics · Authority: European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation
SHA-256 integrity: ccde4c7377e5c91bc6d6a5457ef4ae4b4b6a574ca86ef1f197811b86a5139eee
Primary Citations — 5 traced to source
- {"title":"Regulation (EC) No 726/2004 laying down procedures for the authorisation of medicinal products for human and veterinary use","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R0726","section":"Article 5 (mandatory centralised), Article 7 (dossier), Article 10 (assessment timeline), Article 28 (decision)"}
- {"title":"EMA Human Regulatory - Marketing Authorisation","url":"https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation","section":"Centralised procedure overview, assessment timeline, and submission guidance"}
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