Jurisdiction(s):
United Kingdom

Key definition

Brexit definition

What does Brexit mean? Brexit is the practical shorthand in legal drafting and advice for the United Kingdom’s withdrawal from the European Union and the legal, regulatory and trading changes flowing from it. It covers the UK’s cessation of EU membership on exit day (31 January 2020) and the cessation of the EEA Agreement’s application, the end of the implementation/transition period on IP completion day (31 December 2020), and the commencement, expiry or variation of post‑withdrawal trading and regulatory arrangements, including the UK‑EU Trade and Cooperation Agreement, the Windsor Framework (amending the Northern Ireland Protocol), and UK agreements with third countries...

UK post-Brexit regulation of medicinal products: marketing authorisations, supply continuity, and the Northern Ireland Protocol and Windsor Framework

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note deals with key issues that affect marketing authorisations (MAs) for medicinal products and supply of medicines following the end of the Brexit transition period (11 pm (GMT) on 31 December 2020, referred to in UK law as ‘IP completion day’).

It also provides detail on how the Ireland/Northern Ireland Protocol is being implemented. Further aspects of the regulation of medicinal products after IP completion day are addressed in the following Practice Notes:

Orphan medicinal products
The regulation of advanced therapy medicinal products
Biosimilars
Paediatric medicines
Pharmacovigilance
Falsified medicines
Manufacturing of medicinal products for human use
EU variations to marketing authorisations of medicinal products and UK marketing authorisations for medicinal products — MA variations

For an assessment of the principal life sciences provisions within the EU‑UK Trade and Cooperation Agreement (TCA), see News Analysis: Impact of the EU‑UK Trade Cooperation Agreement and Northern Ireland Protocol on life sciences. Changes to the medical devices framework following the end of the transition period are examined in Practice Note: The regulation of medical devices in the UK...

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Web page updated on 22/05/2026

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