The MHRA maintains a published list of all approved UK products classified as category 1 and category 2 under the new rules following the implementation of the Windsor Framework.
The Windsor Framework, effective since 1st January 2025, changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licenced UK-wide under UK law. These medicines are classified as category 1 products.
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 1st January 2021. These medicines are classified as category 2 products.
To be clear which rules apply for UK authorisations, all authorised products are categorised as either category 1 or category 2. The MHRA has published a comprehensive list for each category on their website detailing the licence number, marketing authorisation holder, active substance, legal status and authorisation type. Note that UK NI (Northern Ireland Only) licences are not included in the categorisation by MHRA.
UK Wide-Licensing under the Updated Rules
Despite there being no change in the UK and EU regulations applicable to category 2 products licenced UK-wide, there has been a change to the type of product licences issued by the MHRA. So while on the surface there is little change to the pharmacovigilance obligations for category 2 products in the EU and UK, there is a significant impact to some UK marketing authorisation holders (MAHs), who have product licences only in the UK.
From the 1st January 2025, the MHRA are no longer issuing GB-only licences (i.e. all licences are UK-wide, including England, Wales, Scotland AND Northern Ireland).
GB authorisations granted by the MHRA on or before 31 December 2024 were automatically converted to UK-wide authorisations on 1 January 2025, unless the GB MA was cancelled by the MA holder or the MHRA by 31 December 2024.
What does this mean for UK MAHs’ pharmacovigilance obligations?
The change from GB-only licences to UK-wide licences has an impact on the pharmacovigilance obligations for MAHs of concerned category 2 products. This is because the pharmacovigilance obligations are now determined by product category and not licence region, i.e. whether or not the product is licenced with respect to Northern Ireland.
In order to summarise the change in obligations based on the situation before and after the 1st January 2025, we also need to consider whether the MAH has an EU licence in an EU member state for the same product (or have only ever had a GB only presence).
| Licence Type prior to 1st Jan 2025 | Licence Type after 1st Jan 2025 | EU product licence? | Change to PV obligations? |
| GB-Only | UK-wide | Yes | No |
| GB-Only | UK-wide | No | YES |
Where UK MAHs of category 2 products had a national GB licence prior to 1st January 2025, UK legislation only was applicable. However, upon conversion to a UK-wide licence and implementation of the Windsor Framework, these products are now also subject to the EU pharmacovigilance requirements. These requirements include the registration of the PSMF and QPPV with EMA via the Article 57 database, reporting of ICSRs to Eudravigilance and PSUR reporting to EMA. However, it is still possible for the QPPV for these products to reside in the UK, accounted for as a concession in the EU regulation.
Do you need to make changes?
If you would like further support in understanding your pharmacovigilance obligations in the UK or EU, we are here to help. We have pharmacovigilance experts based in both the EU and UK with the expert knowledge and experience required to ensure compliance with all pharmacovigilance obligations.
