Guidance

List of approved countries for authorised human medicines in a no deal scenario

Guidance on the lists of approved countries for importing and batch testing of medicines and manufacturing of active substances

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Leaving the EU with a deal remains the Government’s top priority. This has not changed.

However a responsible government must plan for every eventuality, including a no deal scenario. We are continuing with our no deal planning to ensure we are fully prepared.

If the UK leaves the EU without a deal, the Human Medicines Regulations 2012 will refer to lists of approved countries for:

  • Importation of medicines under a wholesale dealer’s licence
  • Batch testing of medicines
  • Manufacturing of active substances with regulatory standards equivalent to the UK

The draft legislation that inserts these lists in to the Regulations is published on the Legislation.gov website. It has not yet been approved by the Houses of Parliament.

This guidance provides the lists of countries and a summary of the circumstances under which the lists can be used.

Published 11 March 2019