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This file may not be suitable for users of assistive technology.
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If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email webupdates@mhra.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use.
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:
Published 31 December 2020 Last updated 28 October 2022 +show all updates
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 Nort
