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

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/080e0685-3d3a-41e2-a813-3f2cb9175b7c
Type: Guidance
Published: February 9, 2026

> Starting February 12, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) will implement changes to pharmacovigilance requirements following amendments to EU Commission Implementing Regulation (CIR) 520/2012. While the United Kingdom operates under the Human Medicines Regulations (HMR) 2012, these updates specifically impact UK-authorized medicines classified as Category 2 products and those held by companies with dual licenses in both the UK and EU. Historically, UK domestic legislation under HMR Schedule 12A was aligned with the EU's CIR; however, the new amendments mean these frameworks will no longer be fully synchronized. Although this guidance does not stem from a specific company inspection or violation, it highlights a critical shift in the regulatory framework that could lead to compliance issues if not managed correctly. Companies are required to evaluate their current pharmacovigilance systems against the MHRA's newly published technical guidance and decision-making flowcharts. Organizations must ensure that their internal processes accommodate the divergence between UK domestic rules and the updated EU requirements to maintain authorization for Category 2 medicines.

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## Content

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.

## Attachments

- [CIR HMR Schedule 12A MAH communication](https://assets.publishing.service.gov.uk/media/698c8ff5bd090be481c2878f/CIR_HMR_Schedule_12A_MAH_communication_-_approved.pdf)