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:

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

MHRA consultation on EU exit no-deal legislative proposals