Guidance on Pharmacovigilance Procedures

On 25 October 2022 the UK MHRA published the updated guidance on PV procedures.

The guidance on Pharmacovigilance Procedures has been updated to include further details on submission requirements and updates for the MHRA, including the following:

  • Risk Management Plans (RMPs) and Post Authorization Safety Studies (PASS)
  • Periodic Safety Update Reports (PSURs) with updates for submissions in Northern Ireland
  • MHRA Safety Reviews and Safety Communications
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