Diamond's appraisal of EMA's Brexit guidance for MA holders


Further to the release of EMA’s additional Brexit Q&A document yesterday, the following should be noted for centralised marketing authorisations:

  • As of 30th March 2019, the UK will become a “third country”;
  • Marketing authorisations currently held by UK entities must be transferred to a legal entity in the EEA;
  • Orphan designations must be transferred to a legal entity in the EEA if currently held by a UK entity;
  • Grouping and worksharing of Brexit related changes is possible in certain scenarios;
  • Variation categories are defined for certain changes to manufacturing, EU QC testing and batch release sites;
  • Mock-ups are required with all MA transfers unless the name and address of the MAH is the only change being made;
  • QPs, QPPVs and PSMFs must continue to be located in the EEA;
  • QPPV and PSMF updates to marketing authorisations can be made via the Article 57 database;
  • Updates to the contact responsible for scientific services, product recalls and quality defects will not require a variation.

You can find the full EMA guidance here.

Diamond Pharma Services can help you manage all of your regulatory, pharmacovigilance and compliance updates required as a result of Brexit.