Claire Longman

Pharmacovigilance Inspector

Impact of the amended CIR 520/2012 to UK authorised products

Claire Longman, 10 February 2026 - Good pharmacovigilance practice, GPvP, Pharmacovigilance

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. …

Guidance updates on to how to notify the MHRA of changes to the PV System

Claire Longman, 29 January 2024 - Good pharmacovigilance practice

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 …

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