Guidance

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

This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 9 February 2026

Documents

CIR HMR Schedule 12A MAH communication

PDF, 257 KB, 2 pages

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Details

From 12 February 2026, amendments to an EU regulation known as ‘the EU Commission Implementing Regulation (CIR) 520/2012’ comes into effect.

While the UK has an independent regulatory framework, these amendments will still have practical implications for some UK authorised medicines, particularly those authorised as Category 2 products or those held by companies with licences in both the UK and the EU.

All UK authorised products are granted authorisations by the MHRA and must meet Pharmacovigilance (PV) requirements set out in Part 11 of the Human Medicines Regulations (HMR) 2012. However, some additional PV requirements apply depending on the Category of product.

• Category 1 products follow the HMR Schedule 12A
• Category 2 products follow additional EU requirements set out in the CIR 520/2012.

Historically, the HMR Schedule 12A has been aligned with the CIR; however, the recent CIR amendment means our domestic legislation will no longer be fully aligned. 

The MHRA has published a further communication to outline this information in more detail, including a flow chart to support decision-making within PV systems.

Published 9 February 2026