Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit

Information for stakeholders so you can make informed plans and preparations in the event of leaving the EU with no deal.



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This guidance is intended to update stakeholders on the UK’s proposed arrangements for the regulation of medicines, medical devices and clinical trials.

See the full list of no deal guidance published by the MHRA.

Published 3 January 2019
Last updated 3 September 2019 + show all updates
  1. Updating of four dates.

  2. We have removed some outdated information, reflecting the publication of more specific guidance in some areas. We have also removed some background information.

  3. Added link to new guidance document about regulating medical devices in the event of a no deal scenario.

  4. 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'.

  5. First published.