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

AI Summary

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.