From 12 February 2026, amendments to the EU Commission Implementing Regulation (CIR) 520/2012 come into effect. While the UK operates an independent regulatory system, these changes have practical implications for some UK-authorised products, particularly in relation to pharmacovigilance (PV) requirements. …
The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …
Join this unique one-day Symposium on 28 February 2024 and hear the latest on Good Pharmacovigilance Practice (GPvP) in the UK from MHRA inspectors and regulators. Registration is available on the GPvP Symposium website for in-person attendance in West London …
Amendments to the guidance on the MHRA website stipulating changes to the way updates to a MAH’s PV system should be notified to the MHRA have been published. The changes aim to make administration burden less for both MAHs and …
The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published on GOV.UK. We hope that the report is informative and useful for considering compliance and improvements within …
Take part in our survey and let us know what you would like to hear about at the next GPvP symposium.
The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020.
All the sources of guidance published by the MHRA so far, plus further information if you still have questions.
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
