MHRA updates for pharmacovigilance in the UK

Written by Steen Ottosen

on 31 October 2022

The MHRA published updated PV guidance on its website on 28-OCT-2022.  The changes involve updates regarding further details on submission requirements for the MHRA, in particular relating to signals, RMPs and PASS. The section on 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.  More details here:

Flowcharts including in the above update and showing the submission requirements for Protocols, Substantial Amendments, Interim and Final Study Reports for non-interventional PASS can be found here:

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