SPC Register and Journal entries from 1 January 2025
Updated 25 February 2025
© Crown copyright 2025
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This publication is available at https://www.gov.uk/government/publications/changes-to-supplementary-protection-certificates-on-1-january-2025/spc-register-and-journal-entries-from-1-january-2025
Background
On 1 January 2025, the law regulating human medicines, and the supplementary protection certificate (SPC) system, changed. You can find more information about the changes at Changes to supplementary protection certificates on 1 January 2025.
These changes mean that some entries in the SPC Register (accessed via our Search for Intellectual Property Service) and the Patents Journal may not fully reflect the legal status of certain SPCs and/or their accompanying authorisations.
This guidance provides information on the issues to be aware of when viewing the details of SPCs via those services.
Marketing authorisation details on SPCs filed before 1 January 2021
- SPCs filed before 1 January 2021 may operate on the basis of an authorisation which is not recorded on the register.
Most SPCs filed before 1 January 2021 relied on EU marketing authorisations that applied to the UK. On that date, these authorisations were automatically converted into GB authorisations which applied in Great Britain. The EU authorisation continued to apply in Northern Ireland as an NI authorisation. Those SPCs then operated relying on both GB and NI authorisations.
(A list of converted GB authorisations is available at Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)).
The Intellectual Property Office (IPO) did not ask for the details of the converted GB authorisation on all such SPCs. Details were only requested where they were needed for processing a live application, usually during the examination stage. This is because, legally, the converted GB authorisation, and the SPC itself, derived from the EU authorisation that was already on the register. Thus, register entries for some of those SPCs may only refer to the EU authorisation.
After 1 January 2025, those SPCs rely on the converted GB authorisation alone, which now applies UK-wide. Although details of that authorisation may not appear on the register, this does not affect the legal basis upon which the SPC operates.
Marketing authorisations with a PLGB prefix
- SPCs where the recorded authorisation has a PLGB prefix may apply UK-wide.
During the process of applying for a marketing authorisation, an authorisation number and prefix is assigned. Prior to 1 January 2025, a marketing authorisation with the prefix ‘PLGB’ would apply to Great Britain only. Similarly, under SPC law, an SPC with this as the sole authorisation would have effect in Great Britain only. The prefix could therefore be a way of identifying the territory in which the SPC was effective.
PLGB marketing authorisations granted before 1 January 2025 now apply to the whole of the UK. But the authorisation number, including its PLGB prefix, remains the same. Applications for authorisations that were pending on 1 January 2025 will also keep the number that has already been assigned. If granted, they will have a PLGB prefix but apply UK-wide.
Any SPC based on such authorisations also has effect UK-wide. This means that the PLGB prefix should not be relied upon as indicative of the territorial effect of the SPC.