Updated Guidance on Pharmacovigilance (PV) Procedures

On 27 October 2020 the MHRA published the updated guidance on PV procedures.

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

The MHRA will retain responsibility for Pharmacovigilance across the UK beginning 1 January 2021. There will be different requirements for some products placed on the market in the UK with respect to Great Britain and Northern Ireland. Great Britain is comprised of 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 authorized in Great Britain, the Marketing Authorization 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-Authorization Safety Studies (PASS) protocols and final study reports
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