Marketing Authorisation

Regulatory

The regulatory approval required for a pharmaceutical product to be placed on the EU market.

Sources

1. European Medicines Agency — What we do ema.europa.eu accessed 23 September 2026

For medicines going through the EU’s centralised procedure, the EMA states that its scientific evaluations “provide the basis for the authorisation of medicines in Europe”, while “the legal decision to grant, suspend or revoke a marketing authorisation … falls under the remit of the European Commission”. So a marketing authorisation is a two-step act: a scientific opinion from the agency, then a legal decision by the Commission — which is why the dates on an opinion and on an authorisation differ.

Describes the EU centralised procedure only. National and mutual-recognition routes differ, and other jurisdictions authorise medicines under their own law.

Common questions

What is the EU marketing authorisation procedure for Indian generics?

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.

Related terms

• BIS Standards
• CBAM
• CDSCO
• CE Marking
• Certificate of Suitability
• CSRD

From the AJG lexicon archive (July 2026).