Brexit: MHRA updates Guidance
Recommendation
17/18 September 2025
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On 02 September, the UK Medicine and Healthcare Agency MHRA has published a Guidance called "Importing Medicines on an approved country for import list from 1 January 2021". This Guideline has now been revised providing more information on sourcing medicine from Northern Ireland to Great Britain.
This goes along with an update of other documents issued by MHRA. Although they are designed for UK companies, it will also have an impact on all companies currently supplying medicines into UK from EU 27 Member States, plus a handful of other countries classified as 'approved countries':
- Importing CT Material into UK
- Sourcing of medicines for UK and Northern Ireland
- Acting as RP for products imported into UK from Approved Countries
Even more details about the Northern Ireland situation are summarised in a Guidance called "Supplying medicines to Northern Ireland from 1 January 2021".
Further advice on independent batch release in the UK for biologicals is given in a "Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021", focusing on the certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools).
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