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UK-MHRA Guidance on Pharmacovigilance Procedures

This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October 2021.

There are 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 authorised for sale or supply in Northern Ireland EU pharmacovigilance requirements will continue to apply in addition to UK requirements as indicated below:

For medicines which are authorised nationally in the UK, the 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

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.

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 before 1 January 2021 and have not been fulfilled will apply to the converted MA, as will any post-authorisation obligations prior to that date.

For more information click on this LINK


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