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Brexit and Orphan Designations

07 August 2018

Brexit

AUTHOR: Antony Appleyard



The EMA is now contacting Orphan Designation holders to reassert the need for their designations to be held in legal entities within the EEA after Brexit.
At Diamond Pharma Services we are committed to providing EU regulatory affairs services, which is why we opened Diamond Pharma Services B.V. as our EU Headquarters based in Amsterdam. We are now actively moving the Orphan Designations that we hold into our legal entity in The Netherlands.

For further details from the EMA visit the following pages:

  1. EMA Orphan Transfer Link
  2. The latest Q&As for Brexit related matters within the framework of the centralised procedure, containing guidance in relation to orphan designations
07 August 2018

Brexit

AUTHOR: Antony Appleyard