What is the EU marketing authorisation procedure for Indian generics?

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

Indian generic pharma companies typically use the Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP) for EU marketing authorisation: (1) file an ANDA-equivalent (ASMF/CTD dossier) with a reference member state (RMS) authority, (2) RMS assesses the dossier (12-18 months), (3) Concerned Member States (CMS) review, (4) Marketing Authorisation granted across 2-27 EU member states. Alternative: Centralised Procedure via EMA — one application, valid in all 27 EU states — used for innovative/complex products.

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