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

What does this involve?

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of approved countries for the:

  • importation of medicines under a wholesale dealz\er’s licence
  • batch testing of medicines
  • manufacturing of active substances with regulatory standards equivalent to the UK

These lists apply from 1 January 2021, when the UK has completed the transition period following Brexit.

From 1 January 2021, the UK will accept certification by a Qualified Person and Active Substance manufacture from countries specified in these lists. These lists will initially include EEA countries and other countries with equivalent regulatory standards. The lists will be reviewed at least every 3 years.

The UK will also accept batch testing done in EEA countries for a period of 2 years after the end of the transition period, until 1 January 2023. This will provide time for industry to adapt supply chains to future UK regulatory requirements.

Am I eligible?

Anyone can use this service.

What does this cost?

This is a free service.

Who is this for?

UK businesses involved in the importation, manufacturing and batch testing of medicines and active substances for human use.

How long does this take?

It takes around 5 minutes to read the full lists and guidance.

Next steps

Visit the UK Government website for more information and to view the full lists.

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