Guidance

Guidance on pharmacovigilance procedures

This guidance summarises our approach to pharmacovigilance

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• Last updated: 8 January 2025 — See all updates

Documents

Guidance on pharmacovigilance procedures

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Fig 1: Submission Requirements - Study Protocol or Substantial Protocol Amendment for Non-Interventional PASS

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Fig 2: Submission Requirements - Final Study Report or Interim Study Results for Non-Interventional PASS

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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.

Published 31 December 2020
Last updated 8 January 2025 + show all updates

1. 8 January 2025

   Links added to guidance and webinar on Windsor Framework

2. 28 October 2022

   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.

3. 14 October 2021

   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.

4. 29 January 2021

   New video entry - Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020

5. 6 January 2021

   Updated section 2 to include a list of reports received via the EMA from the 28 December to the 31 December

6. 31 December 2020

   First published.