Freyr Regulatory Radio

Episode 2. Centralised and Decentralised Procedures


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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
  • ...more
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    Freyr Regulatory RadioBy Freyr Solutions