UK Trade Mark Guide
25th July 2024
Want to know the basics of trade mark protection in the UK? Our handy guide has you covered.
Changes to SPCs and Marketing Authorisations in the UK implemented on 1st January 2025
Supplementary Protection Certificates or SPCs are granted to the proprietor of a valid UK patent that protects the active ingredient of a pharmaceutical, and a marketing authorisation to place the active ingredient on the UK market.
Previously, Centralised authorisation granted by the European Medicines Agency had effect in Northern Ireland, along with NI authorisation granted by the Medicines & Healthcare products Regulatory Agency (MHRA), GB authorisation granted by the MHRA, and UK authorisation granted by the MHRA. Any of these authorisations could be used to form the basis of an SPC application (and a paediatric extension, where applicable).
As of 1 January 2025, this has changed. Centralised authorisations are no longer effective in Northern Ireland, and no longer qualify for a paediatric extension. This applies to both existing Centralised authorisations, as well as new Centralised authorisations granted after 1 January 2025.
Proprietors who previously had both GB and NI authorisations for the same product should ensure their NI authorisation has been surrendered. If not, their GB authorisation will be revoked.
Existing GB authorisations now have effect across the whole of the UK, including NI, and are now UK authorisations. This took effect automatically on 1 January 2025.
A single UK authorisation is now the standard for new drugs and medicines for human use. The process for applying for an SPC will be simpler moving forward. These changes support the Windsor Frameworkâs aim to protect the long-term supply of medicines to Northern Ireland, and the rest of the UK.
Centralised authorisations will not generally be able to be relied upon as the basis for new SPC applications or paediatric extensions now that the changes of 1 January 2025 have taken effect. However, there are still some exceptions, so please get in touch if you require further information.
If you have any questions regarding SPCs, the status of your SPC applications, or your filing strategy, please feel free to contact us.
