Impact of EU CIR 520/2012 on UK Authorised Products

Amendments to the EU Commission Implementing Regulation (CIR) 520/2012 on the performance of pharmacovigilance (PV) activities came into effect in February 2026. These changes have practical implications for certain UK-authorised products, particularly with regard to PV requirements. 

Background

All UK-authorised products are granted authorisations by the MHRA and are subject to PV requirements. However, depending on the category of product, additional PV requirements apply: Category 1 products are subject to further regulations stipulated within the Human Medicines Regulations (HMR) Schedule 12A. Category 2 products are subject to the regulations set out in the CIR (the requirements are currently aligned with those in Schedule 12A).

The MHRA is currently considering updates to Schedule 12A of the HMR to align it with the updated CIR. In the meantime, to provide clarity for the industry, the MHRA has set out the following:

• Marketing Authorisation Holders (MAHs) of Category 2 products: These products are subject to the CIR.
• MAHs of Category 1 products who also have licenses within the EU: Although Category 1 products are subject to the HMR Schedule 12A, where the MAH also holds authorisations in the EU, MAHs should default to following the CIR to enable ease of PV compliance with one set of requirements.
• MAHs of Category 1 products with no EU presence: Continue to follow HMR Schedule 12A.

To support decision-making within PV systems, the MHRA has published additional guidance containing a flow chart detailing the application of the CIR vs. HMR Schedule 12A to UK-authorised products. 

For more information please see the MHRA's Inspectorate Blog.