Collection

MHRA guidance and publications on a possible no deal scenario

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 guidance for manufacturers of biological medicines on the NIBSC website.

We will add further links to this page as new guidance and information is published.

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

Published 31 January 2019
Last updated 19 February 2019 + show all updates
  1. We have added a link to updated guidance for manufacturers of biological medicines on NIBSC.org. The guidance addresses independent batch release in the United Kingdom following the UKs departure from the EU without a deal.
  2. First published.