Brexit: Impact of the UK vote to leave the EU on regulatory affairs

On this page we pull together papers, resources and discussion to help you understand the possible impact of Brexit on regulatory affairs - in the UK, in the rest of Europe and worldwide.

If you know of anything we should add to the page, please email us.

TOPRA members can also join our Brexit online discussion group - sign into the website and go to My TOPRA

TOPRA is not responsible for the content of external links.

Recent Brexit news of note to regulatory affairs

The following news updates originated in our Life-Lines newsletter, a fortnightly members-only email produced in partnership with international law firm Pinsent Masons. For more extensive insight into Brexit's possible effects on healthcare regulatory affairs, plus other recent life sciences-related legal and regulatory developments, become a TOPRA member to receive Life-Lines directly.

Please note: as of January 2021 this page is no longer being updated.

November & December 2020

October 2020

  • Summary report of the EU Pharmaceutical Committee on Brexit readiness for the end of the transition period
  • AnimalhealthEurope publishes Brexit position
  • Ireland's HPRA issues update on Brexit preparation
  • Austria issues reminder about Brexit actions  to be implemented by industry before the end of the transition period
  • UK's VMPD published a several updates  to the "End of transition period information hub", inluding: authorised personnel location, PV system and QPPV, adverse event reporting and PSURs, and an explainer on import/export of veterinary medicines.

September 2020

July 2020

June 2020

May 2020

April 2020

March 2020

February 2020

January 2020

November 2019

October 2019


September 2019

July 2019

June 2019

May 2019

April 2019

March 2019

February 2019

January 2019

December 2018

November 2018

Pinset-Masons have produced a briefing on the Brexit Withdrawal Agreement summarising the accord's key points with a focus on:

  • The Brexit withdrawal process under the Withdrawal Agreement
  • The arrangements during the proposed transition period and so-called 'backstop' arrangement
  • The key areas covered by the Withdrawal Agreement, including Citizens' Rights, Data, and VAT & Excise
  • Actions that businesses should be taking now in order to prepare for Brexit

October 2018

August 2018

July 2018

June 2018

May 2018

April 2018

March 2018

February 2018

General information about the referendum

See the website of the UK Parliament for information on the referendum and the process for UK withdrawal from the EU.

Brexit: What happens now? BBC, 29 June 2016. In particular, scroll down for the useful graphic, 'Steps to the EU leaving the European Union'

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