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UK: MHRA updates guidance on pharmacovigilance procedures

2020/09/09  GOV.UK

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

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.

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

For medicines authorised to be sold or supplied in Northern Ireland information will need to be submitted according to EU requirements. .

For medicines which are the subject of a UK MA covering both Great Britain and Northern Ireland, information will need to be submitted in accordance with requirements for both Great Britain and the EU, as appropriate.

Further guidance on the conversion of Centrally Authorised Products (CAPs) to UK MAs is available on our website. Any conditions or restrictions subject to which the CAP was granted immediately before 1 January 2021 will apply to the converted MA, as will any post-authorisation obligations prior to that date.

In general, submission of historical data will not be required but we may request this where it is needed for assessment purposes. Where a request is made, the data must be supplied to us within the specified time period. MHRA already holds its own database of ICSRs, so will not require historical information from you.

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