EU Regulators Address Challenges in Switching Reference Member State

Executive Summary EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the...
  • Vibha Sharma

Executive Summary

EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the switch in cases where all the strengths of the drug are not approved in any concerned member state.

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Source: pink.pharmaintelligence.informa.com