Changes to supplementary protection certificates on 1 January 2025
How SPC law will be affected by new legislation which comes into force on 1 January 2025, and what actions SPC holders and applicants will need to take.
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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 comes into force on 1 January 2025. This guidance sets out what SPC holders and applicants will 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.
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
Published 31 October 2024Last updated 11 December 2024 + show all updates
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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.