Updates to CIR 520/2012 – information for UK Marketing Authorisation Holders

10th February 2026

Summary: On 9 February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) issued updated information for Marketing Authorisation Holders (MAHs) about the implications of recent changes to CIR 520/2012 — the EU pharmacovigilance implementing regulation — which come into force on 12 February 2026. While UK medicines are regulated under the Human Medicines Regulations 2012, there are ongoing overlaps with EU pharmacovigilance requirements for some products, particularly Category 2 medicines that are authorised both in the UK and the EU.

The guidance explains that UK-only products (Category 1) are governed by UK law (HMR Schedule 12A), but Category 2 products may still be subject to some provisions of CIR 520/2012. Recent amendments to CIR mean that UK domestic legislation and EU pharmacovigilance law will no longer be fully aligned, so the MHRA has provided detailed decision-making information and a flowchart to help MAHs determine which requirements apply and how to integrate them into their pharmacovigilance systems.

This change follows broader updates to EU pharmacovigilance rules — such as clarified signal management, EudraVigilance monitoring expectations, and amended documentation obligations for MAHs under the revised Implementing Regulation (EU) 2025/1466 — which affect how safety data and risk management procedures should be conducted for products authorised in the EU and UK markets.

Link: https://www.gov.uk/government/publications/updates-to-cir-5202012-information-for-uk-marketing-authorisation-holders

Back to Recent News