Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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 switch in cases where all the strengths of the drug are not approved in any concerned member state.

Related Content

Germany Heads List Of EU Countries Taking On UK’s RMS Roles
CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts