Guidance

List of approved countries for authorised human medicines if there is a no-deal Brexit

Approved countries for batch testing and importation of medicines if there is a no-deal Brexit

• From: Medicines and Healthcare products Regulatory Agency
• Published: 11 March 2019
• Last updated: 9 October 2019 — See all updates

This publication was withdrawn on 25 February 2020

For current information see Good manufacturing practice and good distribution practice

Documents

List of approved countries for authorised human medicines on exit day

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Details

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 list of approved countries will enable UK importers and wholesalers to continue to recognise batch testing, QP certification and regulatory standards for active substance manufacture performed in certain countries in the same way as before exit day.

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

This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

Published 11 March 2019
Last updated 9 October 2019 + show all updates

1. 9 October 2019

   Change of text within Stay up to date box.

2. 8 August 2019

   Following the EU now recognising batch testing from the USA, we have edited section 3.3. to reflect which classes of medicines remain excluded. We also removed some outdated background information.

3. 11 March 2019

   First published.