Information about the regulation of medicines and medical devices if the UK leaves the EU with no deal.
Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.
The Agency is publishing a series of guidance documents for industry and other stakeholders covering our proposed arrangements for the regulation of medicines, medical devices and clinical trials, if we leave the EU with no deal.
There is also information on the NIBSC website:
- guidance for manufacturers of biological medicines on the NIBSC website.
- information for customers of biological reference materials
- information for NIBSC collaborators
We will add further links to this page as new guidance and information is published.
Medical devices
Legislation concerning a no deal scenario
Marketing authorisations, variations and licensing guidance
Regulatory submissions and vigilance activities
Technical notices
- How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
- Batch testing medicines if there’s no Brexit deal
- Submitting regulatory information on medical products if there’s no Brexit deal
- Labelling tobacco products and e-cigarettes if there’s no Brexit deal
- Ensuring blood and blood products are safe if there’s no Brexit deal