Guidance

Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

Updated information for stakeholders so they can make informed plans and preparations in the event of leaving the EU with no deal.

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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. We are continuing with our no deal planning to ensure we are fully prepared.

For 2 years, the government has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU on 12 April 2019.

It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon.

In the summer, the government published a series of 106 technical notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations.

This guidance is intended to update stakeholders on the UK’s proposed arrangements for the regulation of medicines, medical devices and clinical trials, if we leave the EU on 12 April 2019 with no deal, so they can make informed plans and preparations.

This is an updated and more comprehensive version of the technical notice on this subject published in August 2018 and includes changes based on responses received to the Medicines and Healthcare products Regulatory Agency (MHRA)’s consultation in October.

These proposals are still subject to parliamentary approval of the changes to the relevant statutory instruments that are required to bring these proposals into law.

The life sciences sector may also wish to consider other relevant notices, including on

This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.

Published 3 January 2019
Last updated 26 February 2019 + show all updates
  1. Added link to new guidance document about regulating medical devices in the event of a no deal scenario.
  2. In section 3.6, 'Regulatory requirements for Investigational Medicinal Product (IMP) for trials', we have replaced the phrase 'the EU's current position is that testing of IMP should be undertaken within the EU/EEA to 'the EU’s current position is that QP certification of IMP must be undertaken within the EU/EEA'.
  3. First published.