No-deal Brexit—the regulation of medicinal products and clinical trials
No-deal Brexit—the regulation of medicinal products and clinical trials

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • No-deal Brexit—the regulation of medicinal products and clinical trials
  • Overview of the implications of a no-deal Brexit for the regulation of medicinal products and clinical trials
  • Marketing authorisations—general considerations
  • Marketing authorisations and medicines—no-deal guidance and legislation
  • Contingency planning
  • Centralised procedure
  • National procedure—no deal
  • Orphan medicines
  • Paediatric medicines
  • Manufacturing and batch release
  • more

As of exit day (31 January 2020), the UK is no longer an EU Member State. However, in accordance with the Withdrawal Agreement, the UK has entered an implementation period, during which it continues to be subject to EU law (for further information on the Withdrawal Agreement, see Practice Note: Brexit—introduction to the Withdrawal Agreement).

If the UK and the EU do not agree on the terms of their future relationship following the implementation period or where the UK regulatory system substantially diverges from that of the EU, considerations similar to those which would have been applicable in case the Withdrawal Agreement had not been reached may still be valid. This Practice Note, which is based on statutory instruments and guidance published before the UK and EU reached the Withdrawal Agreement, deals with key issues that are likely to affect the regulation of medicinal products and clinical trials in a no-deal scenario. This Practice Note will be kept under review and updated as necessary.

For considerations on the impact of the Withdrawal Agreement on the life sciences sector, including the relevance of EU law to the sector, the respective roles of the EU and UK regulators, marketing authorisations, medical devices and clinical trials, see Practice Note: Brexit—implications of the Withdrawal Agreement for the life sciences sector.

Overview of the implications