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Guidance

List of approved countries for authorised human medicines

Approved countries for batch testing and importation of medicines

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
31 December 2020
Last updated:
22 December 2021
Show all updates

  1. Update to post-Brexit protocols

  2. Updated the information about acceptance of batch testing from EEA countries, which will be reviewed before 31 December 2022. Added new information that we will introduce a two-year notice period of any changes to the current position of continued recognition of EU batch testing and conduct a comprehensive review of the future batch testing strategy for the UK. This change is to allow the sector to continue to focus on the pandemic, and to protect the supply of medicines to UK patients.

  3. First published.

Documents

List of approved countries

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Details

The Human Medicines Regulations 2012 refers 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 QP certification and regulatory standards for active substance manufacture performed in certain countries in the same way as before 1 January 2021. The UK’s acceptance of batch testing done in EEA countries will be reviewed before 31 December 2022. A two-year notice period will be given in the case of changes.

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

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

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