Episode 2. Centralised and Decentralised Procedures

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April 4, 2022 • 7 min

Different approval pathways can be explored while entering the European pharmaceutical market. The approval pathways include:

Centralized Procedure (CP)

Decentralized Procedure (DCP)

National Procedure (NP)

Mutual Recognition Procedure (MRP)

Our experts discuss the most explored pathways, CP and DCP, and the eligibility criteria to pursue them for product approval and marketing authorization within the European Union (EU).

Reference Links

EMA overview of the centralised authorisation procedure

European Commission summary of national authorization procedures

CMDh guidance on marketing authorization applications

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