Statutory guidance

Changes to supplementary protection certificates on 1 January 2025

Published 31 October 2024

Marketing authorisations and SPCs

SPCs rely on a patent protecting the active ingredient of the medicine, and a marketing authorisation for the medicine itself. There are several different types of authorisations which currently allow the sale of a medicine for human use in at least part of the UK. This guidance refers to them as follows:

Type of authorisation	Granted by	Has effect in	Prefix identifier
Centralised authorisation*	European Medicines Agency	Northern Ireland	EU/1/
NI authorisation*	Medicines & Healthcare products Regulatory Agency (MHRA)	Northern Ireland	PLNI
GB authorisation	MHRA	Great Britain	PLGB
UK authorisation	MHRA	United Kingdom	PL

(* Both centralised authorisations and NI authorisations fall under the term “NI authorisation” in the SPC legislation.)

Any of these types of authorisations may currently be used as the basis for an SPC application. The resulting SPC provides protection in the territory covered by those authorisations that have been notified to the IPO.

If the medicine has been the subject of studies for use in children, the SPC may be awarded a further period of protection (“paediatric extension”). The conditions for the paediatric extension apply separately to each authorisation. Proof of compliance with those conditions may be different for each. The extension may apply in different parts of the UK to the SPC itself.

Changes to marketing authorisations taking place on 1 January 2025

On 1 January 2025, the law on how medicines for human use are authorised in the UK will change. This is to put in place provisions agreed in The Windsor Framework to protect the long-term supply of medicines to Northern Ireland.

The changes mean that:

• Centralised authorisations will no longer be effective in Northern Ireland. They will also no longer qualify for the award of a paediatric extension. This will apply to both existing authorisations and new authorisations granted after 1 January 2025
• Existing GB authorisations will have effect across the whole of the UK. They will become UK authorisations, although they will still have a PLGB prefix if that was assigned at the time of application
• Holders of GB and NI authorisations for the same product must have surrendered their NI authorisation by 30 September 2024. Where they do, the GB authorisation will have effect across the whole of the UK. Otherwise, the GB authorisation will be revoked
• From now on, a single UK authorisation will be the standard for new and innovative drugs. There may be some circumstances where that does not apply

We have introduced the Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 to update the SPC legislation for these changes. This new legislation was laid in Parliament on 31 October 2024 and will also come into force on 1 January 2025.

Transitional arrangements for SPCs

The new legislation provides transitional arrangements for handling existing SPCs, applications, and marketing authorisations in light of the changes that take place on 1 January 2025.

These arrangements should apply automatically, but there may be specific cases where you need to take some additional action or remember to follow the current requirements.

Whether you need to take action will depend on where your SPC or SPC application is in the process. It will also depend on which authorisations you have filed with, or notified to, the IPO on 1 January 2025. The guidance refers to these as the authorisations you are relying on. Unless the guidance indicates otherwise, references to SPCs includes applications that the IPO has not yet granted, whose territorial scope would be indicative.

The guidance below only deals with situations where our data has shown there will be live cases.

Existing SPCs and applications

If you are relying on a centralised authorisation and a GB authorisation:

(This includes SPCs applied for pre-Brexit, where an EU authorisation will have been divided into two parts on 1 January 2021.)

You will not need to take any action. The centralised authorisation will no longer be effective in Northern Ireland, but the GB authorisation taking effect across the whole of the UK will replace it automatically. The territorial scope of the SPC will remain UK-wide.

If you are relying on a centralised authorisation only:

The authorisation will be treated as being withdrawn on 1 January 2025.

If you have filed an SPC application that is not yet granted, this will not affect the examination of that application. We assess whether the conditions for granting an SPC are met at the date of filing, so this will proceed as normal.

But if that application is granted, you will need to have a UK authorisation in place before your patent expires. Otherwise, the SPC will not come into effect. You will need to notify us of that authorisation within 6 months of its grant, in line with the existing requirements under Article 13A.

This will also apply if we have granted an SPC but it is not yet in force.

If your SPC is already in force, and you were granted a GB authorisation for the product after the SPC was in force, special provisions will apply. Your SPC will remain limited to Northern Ireland, but it will be based on the GB authorisation that will apply in Northern Ireland as a UK authorisation from 1 January 2025.

If you are relying on a GB authorisation only:

In most cases, you will not need to take any action. Your SPC will automatically extend to cover Northern Ireland without the need to notify us of that change. The details of your authorisation will remain the same, so we will not need any more information from you.

However, if a centralised authorisation or NI authorisation for the product has been granted before 1 January 2025, you will still need to notify us within the six-month deadline set out in Article 13A. Otherwise, the SPC will not properly apply in Northern Ireland.

If you are relying on an NI authorisation and a GB authorisation:

If you have surrendered your NI authorisation, there will be no overall effect on your SPC. The GB authorisation will replace it automatically as it takes effect across the whole of the UK.

If you have not surrendered your NI authorisation, your SPC will no longer provide protection in Great Britain from 1 January 2025.

We may write to you and ask you to confirm the status of your authorisations.

If you are relying on a UK authorisation:

You will not need to take any action, as these changes will not affect existing UK authorisations.

New applications after 1 January 2025

You will generally not be able to rely on centralised authorisations as the basis for a new SPC application after 1 January. This is because the authorisation must be valid on the date of application, and these authorisations will no longer be effective in Northern Ireland.

You may still file an SPC application after 1 January 2025 that relies on a centralised authorisation, provided that:

• the authorisation was granted before 1 January 2025;
• your application deadline is set by Article 7(1) (that is, by the grant of that authorisation or the equivalent GB authorisation); and
• that deadline expires after 1 January 2025

You must file the application within the normal six-month period. This exception may therefore apply if your centralised authorisation was granted between 1 July 2024 and 31 December 2024 and your application deadline expires no later than 30 June 2025.

Any GB or UK authorisation granted before making the application must also be filed with that application. You will not be able to use such authorisations to file a separate application later.

We will examine any application relying on this exception in the normal way, treating the centralised authorisation as being valid at the date of application. If the application meets the statutory requirements, we will grant an SPC.

But that SPC will only come into force if you have a UK authorisation in place for the product, and have informed the IPO, by the time the patent expires. You may either file the authorisation as part of the application, as mentioned, or make a notification using form SP6. Any notification must be made within six months of the UK authorisation being granted. Failing to do so will mean your SPC will not take effect when your patent expires.

If this exception does not apply, you will still be able to file an SPC application using authorisations granted by MHRA. If your application uses an existing GB authorisation that will now have effect across the whole of the UK, any SPC granted will provide UK-wide protection.

If your application deadline is set by Article 7(2) (where your patent is granted after your authorisations), any centralised authorisation will not count against you when determining if your authorisation is the first one granted for the product in the UK.

Paediatric extensions

After 1 January 2025, you will no longer be able to rely on a centralised authorisation to support a request for a paediatric extension.

We will continue to assess requests for an extension filed before 1 January 2025 based on the current (i.e., pre-2025) law. So, an existing request based on a centralised authorisation will still be allowed, if it meets the relevant requirements.

This will only apply where the request meets those requirements before 1 January 2025, or the statutory deadline for filing the request would expire by then. In other words, the European Medicines Agency must have assessed the authorisation for compliance.

It will not apply where the centralised authorisation has not been assessed for compliance and the statutory deadline expires after 1 January 2025. Any request filed based on that centralised authorisation may be refused as unsupported. Instead, you should wait to file a request based on the equivalent UK authorisation at the appropriate time. This will either be when MHRA has assessed it, or by the statutory deadline.

Extensions that have already been granted will continue to rely on the current law.

If you have an extension or pending request based on a GB authorisation that will extend to cover Northern Ireland on 1 January 2025, the extension will automatically apply in Northern Ireland as well. You will not need to file a separate request to include Northern Ireland in that extension.

If you have an extension or pending request based on a centralised or NI authorisation, you will still need to file a request under Article 13B to include Great Britain in that extension. This would be on the basis of a UK or GB authorisation.

How changes to marketing authorisations affect the SPC system

As UK authorisations will become the standard for medicines for human use, in most cases the process for applying for an SPC will be simpler in future.

There will be only one authorisation involved, so the deadline for filing will still depend on whether your patent or marketing authorisation is granted first. You will not need to also determine which authorisation sets the deadline.

You will only need to provide details of one authorisation in the UK as the basis for your SPC when applying.

You will still need to provide details of the earliest authorisation for the product in the European Economic Area if that predates that UK authorisation. This is required to determine the duration of the SPC. This will now include any centralised authorisation that predates the UK authorisation. You will need to provide its details in a different part of the application form.

Any SPC that is granted will generally have effect across the whole of the United Kingdom. There may be extremely rare cases where a UK authorisation is not granted. For those, the process for SPC applications based on GB or NI authorisations will remain in place.

A paediatric extension will only be available based on authorisations with proof of compliance from MHRA. This applies even where the EU agreed the original paediatric investigation plan.

More information

To help you, the IPO has put together a consolidated version of the legislation as it will look from 1 January 2025. This is an informal consolidation and has no legal effect.

• Consolidated version of Regulation 469/2009 (RTF, 495 KB)

The Manual of Patent Practice will be updated to reflect these changes in due course. You should continue to consult this page in the meantime.

If you have a query about how these changes might affect a particular application, please contact the SPC examination team at SPC@ipo.gov.uk.

For more information on the changes to the regulatory system for human medicines, you should consult MHRA’s guidance on UK-wide licensing for human medicines.