Changes to supplementary protection certificates on 1 January 2025
How SPC law is affected by new legislation which came into force on 1 January 2025, the actions SPC holders and applicants need to take, and the issues they need to be aware of.
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Details
Supplementary protection certificates (SPCs) provide additional protection for patented medicines and pesticides, which are required to go through extensive testing and approval before they can be authorised for sale.
New legislation on SPCs came into force on 1 January 2025. This guidance sets out what SPC holders and applicants need to do as a result of that legislation. This will depend on what marketing authorisations your SPC or SPC application relies upon, and its status on that date.
Guidance is also provided on issues that customers need to be aware of when viewing details of SPCs via our online services, following this legislation.
This guidance deals with SPCs for medicines for human use only. SPCs for veterinary medicines and pesticides are not addressed.
(There is a separate small change for veterinary medicines on 1 January 2025. This will reflect that marketing authorisations for Northern Ireland are being granted under different law. It will not require SPC applicants or holders to take any additional action.)
Updates to this page
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Further guidance added on ‘SPC Register and Journal entries from 1 January 2025’. This guidance previously appeared in Patents Journal special notices.
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Additional guidance added to the ‘Existing SPCs and applications’ section for SPCs filed before Brexit – you will not need to tell us about your GB authorisation.
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First published.