Guidance

List of approved countries for authorised human medicines

Approved countries for batch testing and importation of medicines

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

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 [email protected] or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

• Association of the British Pharmaceutical Industry (ABPI): [email protected]
• British Generic Manufacturers Association (BGMA): [email protected]
• BioIndustry Association (BIA): [email protected]
• Clinical & Contract Research Association (CCRA): [email protected]
• Ethical Medicines Industry Group (EMIG): [email protected]
• Health Food Manufacturers’ Association (HFMA): [email protected]
• The National Pharmacy Association (NPA): [email protected]
• Proprietary Association of Great Britain (PAGB): [email protected]

Published 31 December 2020
Last updated 22 December 2021 + show all updates

1. 22 December 2021

   Update to post-Brexit protocols

2. 16 March 2021

   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. 31 December 2020

   First published.