MHRA – Pharmacovigilance – Categories 1 and 2 medicinal products

The Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law.

Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), as has been the case since 1 January 2021.

As a result, UK authorised products are now placed into one of two Categories:

Category 1 are UK products which fall under the mandatory or optional scope of the EU Centrally Authorised Procedure.

Category 2 are UK products which do not fall within the scope of Category 1 will be Category 2 products.

To assist MAHs in verifying the category of each of their products, a decision ladder has been created by the MHRA. The MHRA has also publish lists of Category 1 products and Category 2 products.

Which category your product falls under, will decide the pharmacovigilance requirements of that product.

Category 1 will be subject to UK legislation only. These products will legally be required to follow Part 11 of the HMRs for pharmacovigilance.

Category 2 will be subject to UK and EU requirements as applicable. These products will be legally required to follow Part 11 of the HMRs for pharmacovigilance with further pharmacovigilance requirements outlined in Schedule 12A of the HMRs.

However, it should be note that all existing exemptions that apply to all UK medicines remain in place irrespective of Category.

The MHRA has published Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority which outlines the requirements of products classed as Category 1 or 2, they have also published guidelines to clarify ICSRs reporting  and PSUR submissions requirements for each category.

If you need assistance with any of the above or anything Windsor Framework related, please free feel to contact us.

Written By

Fiona Downey