The implementation of the Windsor Framework on 1 January 2025 marked a significant turning point in the UK’s regulatory landscape for human medicines. Among the most consequential changes are those affecting the legal basis and procedural requirements for Supplementary Protection Certificates (SPCs) and paediatric extensions. These reforms bring long-awaited simplification to a system that, since Brexit, had become increasingly fragmented and administratively burdensome.
A UNIFIED REGULATORY BASIS FOR HUMAN MEDICINAL PRODUCT SPCS
Prior to 2025, the UK’s departure from the EU left it with a bifurcated regulatory regime: while the Medicines and Healthcare products Regulatory Agency (MHRA) would authorise medicines for Great Britain, Northern Ireland remained aligned with the EU system under the Northern Ireland Protocol. This meant that SPC applicants were required to obtain both a GB marketing authorisation (MA) from the MHRA and an EU-wide MA from the European Medicines Agency (EMA) that was valid in Northern Ireland. The result was a cumbersome two-step SPC filing process, with the risk of misalignment between the two authorisations.
The Windsor Framework has now resolved this issue by establishing a single UK-wide regulatory regime for human medicines.
From 1 January 2025, all new SPC applications for human medicinal products must be based on a UK-wide MA granted by the MHRA. EMA centralised authorisations are no longer recognised in Northern Ireland and cannot be used as the basis for an SPC in the UK.
This change brings welcome clarity and efficiency to the human medicinal products SPC system, aligning it more closely with the unitary approach that existed prior to Brexit.
Nevertheless, as we explained in our previous article, a two-tier system remains for SPCs for veterinary medicinal products (and to some extent for plant protection products also).
TRANSITIONAL PROVISIONS AND EXISTING RIGHTS
The UK Intellectual Property Office (IPO) has issued detailed guidance on how the changes introduced by the Windsor Framework affect existing SPCs and pending applications. The transitional arrangements are designed to ensure continuity of protection while aligning future filings with the new UK-wide authorisation model.
From 1 January 2025, the following rules apply for UK SPCs filed before 1 January 2025:
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Marketing authorisation(s) relied on for UK SPC |
Status |
Action Required |
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EMA authorisation (for NI) only
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Examination continues as normal, but EMA authorisation treated as withdrawn. Where the SPC had not yet come into force by 1 January 2025: The SPC will only take effect if a valid UK-wide marketing authorisation (granted by the MHRA) is in place before the expiry of the basic patent, and the UKIPO is notified of that authorisation within six months of its grant and before patent expiry. If these conditions are met, the SPC will apply across the whole of the UK. Where the SPC had already come into force by 1 January 2025: The SPC will cease to have effect unless a GB marketing authorisation was granted before 1 January 2025 and while the SPC was already in force. In that case, the SPC will continue to provide protection, but only in Northern Ireland, and no further notification to the UKIPO is required. |
If not yet in force: Ensure MHRA authorisation is granted and notify IPO within 6 months of grant and before patent expiry If already in force: No action required if MHRA authorisation was granted before 1 Jan 2025; otherwise, nothing can prevent the SPC from lapsing |
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MHRA GB authorisation (PLGB) only |
In most cases, the SPC will automatically extend to cover Northern Ireland, as the GB authorisation will be treated as UK-wide. However, if a centralised or NI-specific authorisation was granted before 1 January 2025, the SPC will not apply in NI unless that authorisation was notified to the UKIPO within six months of its grant and before the patent expires. |
No action required if no other authorisation exists Notify UKIPO if a centralised or NI MA was granted pre-2025, within 6 months of grant and before patent expiry. The final feasible deadline for such notification is 30 June 2025. |
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EMA authorisation (for NI) + MHRA GB authorisation |
No change to territorial scope. The EMA authorisation will no longer be valid in NI, but the GB authorisation will automatically extend to cover the whole of the UK. The SPC will remain UK-wide. This also applies to SPCs filed before 1 Jan 2021, where at that point the EMA authorisation was split into GB and EMA (for NI) parts. The absence of the GB authorisation details in the register does not affect the SPC’s legal effect. |
No action required |
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MHRA GB authorisation + MHRA NI authorisation |
Holders of a GB+NI pair of MHRA authorisations were required to surrender the NI authorisation by 30 September 2024, otherwise the GB authorisation would be revoked. Hence, if the NI authorisation was surrendered by 30 September 2024, the GB authorisation now applies UK-wide and the SPC remains valid across the UK. If the NI authorisation was not surrendered by 30 September 2024, the SPC no longer provides protection in GB and is limited to NI. |
No action required |
NEW SPC APPLICATIONS FILED AFTER 1 JANUARY 2025
From 1 January 2025, the default position is that new SPC applications must be based on a UK-wide marketing authorisation granted by the MHRA. EMA centralised authorisations are no longer valid in Northern Ireland and, as such, cannot generally be used as the basis for new SPC filings.
However, a limited exception applied to centralised authorisations granted in the final six months of 2024. If an EMA authorisation was granted between 1 July and 31 December 2024, and the six-month SPC filing deadline set by Article 7(1) of the retained SPC Regulation (i.e. based on the date of the authorisation) fell after 1 January 2025, an SPC application was still able to be filed relying on that EMA authorisation—provided it was submitted within the normal six-month window.
In such cases:
- The EMA authorisation will be treated as valid for the purposes of examining the application.
- The SPC will only come into force if a UK-wide MHRA authorisation is in place before the expiry of the basic patent, and the UKIPO is notified of that authorisation within six months of its grant.
- If a GB or UK MHRA authorisation had already been granted at the time of filing, it was required to be included with the application. Otherwise, the MHRA application can be notified later using Form SP6.
For applications where the filing deadline is triggered by Article 7(2) of the retained SPC Regulation (i.e. six months from the grant of the basic patent), any EMA authorisation granted before 1 January 2025 will not prevent the use of a later MHRA authorisation. Under the transitional rules, such EMA authorisations are disregarded when determining whether the MHRA authorisation is the first in the UK for the purposes of Article 3(d) of the retained SPC Regulation.
IMPLICATIONS FOR PAEDIATRIC EXTENSIONS
The changes also extend to paediatric extensions. Previously, a six-month extension to an SPC could be obtained on the basis of a paediatric investigation plan (PIP) compliance statement issued by the EMA. However, from 1 January 2025, EMA-issued compliance statements can no longer be used to support new paediatric extension requests in the UK. Any request filed after this date must be based on a UK or GB authorisation and a compliance statement issued by the MHRA.
The UKIPO will continue to assess requests filed before 1 January 2025 under the pre-existing rules. This means that if a request was filed before 1 January 2025 and the EMA had already issued a compliance statement, or if the statutory deadline for filing the request expired before 1 January 2025, then the request may still be granted, even if it relies on an EMA authorisation.
However, if the EMA compliance statement was not issued before the deadline, or if the deadline falls after 1 January 2025, the request may be refused. In such cases, applicants should wait to file a request based on the equivalent MHRA authorisation and compliance statement.
Extensions that have already granted will continue to rely on the current law.
For extensions or pending requests based on a GB authorisation that extended to cover NI on 1 January 2025, the extension automatically applies in NI as well. No separate request is needed to expand the scope.
For extensions based on a EMA centralised or NI-only authorisation, it will not apply in GB. A separate request will be required to extend the protection to GB, supported by a valid MHRA authorisation with compliance statement, and the request must be filed by two years prior to SPC expiry.
SUMMARY
While the Windsor Framework introduced a welcome simplification to the UK SPC system—moving towards a single, UK-wide authorisation model for human medicinal products—most SPC holders will not need to take any new action as a result of these changes. Existing rights will generally continue unaffected, and the transitional provisions are designed to preserve the validity of SPCs already on the register or in progress.
That said, there are still important details to monitor. The obligation to notify the UK IPO of a new MHRA authorisation remains in place where an SPC was originally filed on the basis of an EMA authorisation, regardless of when the SPC was filed. This notification must be made within six months of the MHRA authorisation being granted and before the expiry of the basic patent.
In practice, this means regulatory and IP teams should remain closely aligned—not just for new SPC filings, but also to ensure that any new UK approvals are flagged in time to meet ongoing notification requirements. While the system is now more coherent, careful attention to these transitional obligations will help avoid unintended gaps in protection.
