MHRA Updated Guidance on Pharmacovigilance Procedures

On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.

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 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

These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support patient safety in the UK.

The Good Vigilance Practices (GVP) modules will remain in force but MHRA will publish a guidance note on the exceptions and modifications to the EU guidance on good vigilance practices in due course.

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