Guidance

VMD Information Hub

This is the hub for all the Veterinary Medicines Directorate's communications on the Transition Period.

During the Transition Period

The following information is intended for Marketing Authorisation holders (MAH).

Submit and manage your marketing authorisations

The UK cannot act as Reference Member State, Rapporteur or Co-rapporteur.

You can submit and securely communicate with us about UK national applications using either the EU systems or the VMD’s Digital Service. European applications must continue to be managed though the EU systems.

The UK will:

  • accept an MAH location based in the EU, as approved on a Marketing Authorisation
  • recognise batch release performed by a Qualified Person based in the EU and certification issued by an EU competent authority for immunological and pharmaceutical products
  • recognise inspections carried out by EU competent authorities
  • continue to access 3rd country Pharmacovigilance data from EU systems

For information on how to maintain your marketing authorisations in the EU contact the European Medicines Agency.

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Published 31 January 2020