UK – Updated guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal

This document outlines the submission requirements for pharmacovigilance data in a no-deal Brexit. The Medicines and Healthcare products Regulatory Agency (MHRA) has primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK Marketing Authorisations (MAs), certificates of registration and traditional herbal registrations.

Sharing of common systems, and formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries will cease.

From Brexit, for medicines authorised in the UK, you, as a MA Holder (MAHs), will be required to submit pharmacovigilance data to the MHRA, including:

  • UK and non-UK Individual Case Safety Reports (ICSRs)
  • Periodic Safety Update Reports (PSURs)
  • Risk Management Plans (RMPs)
  • Post-Authorisation Safety Studies (PASS)

These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support UK public health…