MHRA updated guidance on pharmacovigilance procedures

On 28th October 2022, the MHRA published updated guidance on PV procedures. Changes 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.

https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures/guidance-on-pharmacovigilance-procedures