Guidance on pharmacovigilance procedures
This guidance summarises our approach to pharmacovigilance
Documents
Details
See Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply to UK MAHs and the MHRA
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars:
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020
Webinar recording on changes introduced by the Windsor Framework to UK authorised medicinal products, which took place on 19 September 2024
https://www.youtube.com/watch?v=q4Mp2H3PzZs
Further information regarding the impact on Pharmacovigilance following the implementation of the Windsor Framework for UK authorised products can be found within our pharmacovigilance Windsor Framework guidance and Q&A document.
Updates to this page
Last updated
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Links added to guidance and webinar on Windsor Framework
Update history
2026-08-21 16:16
Added further information on EURD list under section 5.2 of guidance
2025-01-08 16:31
Links added to guidance and webinar on Windsor Framework
2022-10-28 13:48
The guidance on Pharmacovigilance Procedures has been updated to include further details on submission requirements for the MHRA, in particular relating to signals, Risk Management Plans (RMPs) and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been updated with new requirements for submission of PSURs for products authorised in Northern Ireland. Additional sections have included on MHRA Safety Reviews and Safety Communications.
2021-10-14 13:32
The guidance on pharmacovigilance procedures has been updated to provide clarity on submission and documentation requirements for various pharmacovigilance procedures including where the reliance procedure is used.
2021-01-29 12:30
New video entry – Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020