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. Products placed on the market in Northern Ireland will need to be in line with EU legislation and follow EU requirements. More details will follow in due course.
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 GB 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