UK – Guidance on pharmacovigilance procedures from 1 January 2021

This guidance summarises our approach to pharmacovigilance from 1 January 2021.

This document outlines the submission requirements for pharmacovigilance data from 1 January 2021.

The MHRA will retain responsibility for Pharmacovigilance across the UK from 1 January 2021. There will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. Great Britain is England, Wales and Scotland. For products placed on the market in Northern Ireland requirements will, in general, remain in line with EU requirements as indicated below.

From 1 January 2021, for medicines authorised in Great Britain, you, as a Marketing Authorisation Holder (MAH), will be required to submit pharmacovigilance data to the MHRA, according to UK requirements, including:

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