UK: Brexit Update and Related MHRA Guidance
December 30, 2020
As of December 24, 2020, the UK and the European Union (EU) have reached a post-Brexit trade agreement. It is unlikely that the deal will be formally ratified before the transition period ends and Brexit comes into full force on January 1, 2021. See this website for more details about the agreement. ClinRegs will continue to monitor Brexit developments and update the profile accordingly.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published the following Brexit-related guidance documents:
- Letter to medicines and medical product suppliers: 17 November 2020 (December 28, 2020) – updated to confirm that the post-Brexit trade agreement reached between the UK and the EU does not remove any requirements to prepare for new customs and border processes.
- Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply to UK MAHs and the MHRA from 1 January 2021 (December 24, 2020) – clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices from 1 January 2021.
- Registering to make submissions to the MHRA from 1 January 2021 (December 23, 2020) – updated to include guidance on regulatory submissions made through European procedures and additional guidance for pharmaceutical companies making submissions via MHRA Submissions.
- Guidance on submitting clinical trial safety reports from 1 January 2021 (December 18, 2020) – provides guidance on reporting Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) using the new reporting routes; registering for ICSR Submissions, a web reporting tool that will replace the EudraVigilance website; registering for the MHRA Gateway, which will replace the Eudravigilance Gateway; reporting SUSARs using the eSUSAR website; the transition between reporting to EU and UK systems; the Business Continuity Plan for MHRA Gateway and ICSR Submissions; and submitting Development Safety Update Reports (DSURs) to the MHRA.
- Supplying Investigational Medicinal Products to Northern Ireland from 1 January 2021 (December 11, 2020) – provides guidance on what is required for supplying investigational medicinal products (IMPs) from Great Britain to Northern Ireland until December 31, 2021 and starting January 1, 2022.
The ClinRegs team will review these documents and incorporate them into the UK profile where appropriate.