Guidance: List of approved countries for authorised human medicines from 1 January 2021

Medicines Healthcare Products Regulatory Agency

September 25
15:32 2020


From 1 January 2021, the?Human Medicines Regulations 2012?will refer to lists of approved countries for:

  • Importation of medicines under a wholesale dealers 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 1 January 2021.

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 1 January 2021 in line with the?Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period.

Published 1 September 2020
Last updated 25 September 2020 +show all updates
  1. An edit has been made to clarify timings and certifications under the point 1. List of approved countries from 1 January 2021

  2. First published.

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