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

11th February 2026

Summary: The MHRA Inspectorate outlines the implications of the amendments to CIR 520/2012, which came into effect in February 2026 and mean that EU pharmacovigilance expectations are no longer wholly aligned with the UK’s own pharmacovigilance regime. While UK-only products (Category 1) are governed exclusively by the Human Medicines Regulations 2012, products authorised in both the UK and EU (Category 2) may still be subject to certain EU requirements under CIR 520/2012 where those provisions continue to apply in EU jurisdictions. The blog stresses that marketing-authorisation holders (MAHs) should carefully assess which requirements are mandatory in the UK versus which relate only to EU obligations, update their pharmacovigilance system master files accordingly, and ensure appropriate signal detection, periodic safety update reporting and risk-management planning processes are in place for each market. The Inspectorate also provides practical examples and directs readers to updated MHRA guidance and flowcharts to support decision-making and compliance during the transition period.

Link: https://mhrainspectorate.blog.gov.uk/2026/02/10/impact-of-the-amended-cir-520-2012-to-uk-authorised-products/

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