Guidance

UK-wide licensing for human medicines

Published 29 September 2023

This guidance is designed to provide information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.

The Windsor Framework will be implemented from 1 January 2025^{[footnote 1]}.

After the implementation of the Windsor Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the whole of the UK.

This licensing guidance should be used in conjunction with other relevant MHRA guidance, including the labelling & packaging guidance published in July 2023.

Glossary of terms

For the purposes of clarity and consistency, this guidance uses the following definitions of key terms:

• PL: a product licensed by the MHRA that covers the whole of the UK, coming into effect from 1 January 2025.
• UK-wide MA: a product licensed by the MHRA, across the whole of the UK, before 1 January 2025.
• PLNI: a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application.
• PLGB: a product licensed by the MHRA that covers Great Britain (GB) only as the territorial application.

UK-wide Licensing

The implementation of the Windsor Framework will enable the MHRA to license products that fall within scope of the EU’s Centralised Procedure, which would currently require a European Commission (EC) authorisation for NI^{[footnote 2]}.

Following changes made to EU legislation in April 2022 by the European Commission, most products not under the scope of the EU centralised procedure are already able to be authorised UK-wide by the MHRA. From 1 January 2025, the MHRA will be able to license centrally authorised products (CAP) in addition to non-CAP products under one UK-wide regime.

From the implementation of the Windsor Framework on 1 January 2025, the MHRA will regulate medicines across a UK-wide licensing regime. Most new Marketing Authorisation Applications (MAAs) will be granted as PL licences covering the whole of the UK. The MA number will have a PL prefix.

Marketing Authorisation Holders (MAHs) will not be able to apply for a PLGB after 31 December 2024.

From 1 January 2025, new applications for products that fall under the mandatory or optional scope of the EU centralised procedure will be licensed under UK law and on a UK-wide basis. All new and innovative medicines, orphan medicinal products, Advanced Therapy Medicinal Products (ATMP) and paediatric medicines authorised will be granted PLs.

Territorial application

From 1 January 2025 it will not be possible to simultaneously hold a PL and a PLGB or PLNI for the same product. The guidance below outlines these scenarios.

PLGBs

Subject to guidance under PLNIs below, by default existing PLGBs will automatically become valid for the whole of the UK as PL licences on 1 January 2025, unless the PLGB is cancelled by the MHRA by 31 December 2024.

No action is necessary for this conversion for Marketing Authorisation Holders who only hold a PLGB licence for a particular product. However, MAHs will need to comply with the necessary requirements for labels, leaflets and packaging for medicines. This includes submitting updated packaging and labelling information to the MHRA where required.

PLNIs

MAH holds a PLNI and PLGB for the same product

If a MAH currently holds both a PLNI and a PLGB for the same product and wishes to retain UK-wide authorisation, the PLNI will need to be cancelled in order for the existing PLGB to be converted to a PL. This is because you cannot hold a PLNI and PL simultaneously for the same product.

To cancel a PLNI, the MAH should:

• Inform the Reference Member State (RMS) of its intention to withdraw NI as a Concerned Member State (CMS) from the Mutual Recognition Procedure or the Decentralised Procedure (MRP/DCP).
• Submit a request to the MHRA by 30 September 2024 to cancel the PLNI. The covering letter should refer to the Windsor Framework and specify the effective date of cancellation as 31 December 2024.
• The PLGB component will automatically convert to a PL on 1 January 2025.

If the MHRA does not receive a request by 30 September 2024 to cancel the PLNI, the MHRA will automatically cancel the PLGB. This means that only the PLNI will remain from 1 January 2025.

MAH holds a PLNI only

Where a MAH only holds a PLNI and subsequently seeks authorisation for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the PL. MAHs involved in EU procedures, with NI included as a CMS, will need to notify the RMS to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new PL.

Existing UK-wide licences granted through the MRP/DCP

For existing UK-wide licences granted through routes such as the MRP or DCP prior to EU Exit, where NI remains a CMS in the EU procedure, these can continue to be managed in alignment with the EU product, unless there is a requirement for UK-specific changes, which would then require withdrawal of NI from the procedure. The existing UK-wide MA will then be managed as a standalone PL. Where the MAH currently holds a PLGB and a PLNI (where the PLNI is through the MRP/DCP), it is possible for the MAH to cancel the PLGB and retain a PLNI through the MRP/DCP only.

Existing licence numbers

The change in territorial scope of a licence does not require a change in licence numbers. Medicines with existing PLGB numbers will become geographically valid UK-wide, where the PLGB converts to a PL. However, these medicines will retain the same licence number, including the prefix ‘PLGB’. These letters will no longer have any relevance in terms of the territorial scope of legal supply. ‘PLNI’ however, will continue to denote medicines that can be supplied to NI only.

New applications for generics

Reference Medicinal Products (RMPs)

Until the implementation of the medicines changes on 1 January 2025, following the agreement of the Windsor Framework, the EU remains responsible for authorising medicines in Northern Ireland that fall under the mandatory scope of the centralised procedure (mostly new and innovative products). UK-wide MAAs for generics of these products will need to cite the centrally authorised product as the reference product until 31 December 2024. Applications for UK-wide generics of non-CAP products will have to cite a UK-wide licence as a reference product, or a European Reference Product (ERP) until 31 December 2024. From 1 January 2025, it will only be possible to cite ERPs for applications for PLNIs through the MRP/DCP.

From 1 January 2025, the MHRA will be responsible for authorising new and innovative medicines through the issuing of PL licences. These PL products can then be cited as RMPs in UK-wide generic MAAs. Existing PLGB licences will also be valid for the whole of the UK, once converted as outlined above.

Only RMPs that are or have been authorised for at least 8 years in the UK (or GB prior to 1 January 2025) will be valid for generic and hybrid MAAs received from 1 January 2025. The use of ERPs in UK-wide MAAs submitted from 1 January 2025 will not be possible.

Valid RMPs will include products authorised through the CAP grandfathering process (currently authorised as PLGBs) and other suitable PLGBs; which will be converted to PLs.

Applications for medicines for which a valid RMP authorised in the UK cannot be established will need to be submitted under a different legal basis e.g., a well-established use application, or a full mixed application.

The current position on the use of international comparator products that applies across GB only will be expanded to cover the whole of the UK from 1 January 2025. This means that comparator products should be generally sourced from the UK, however, if the comparator product is not sourced from the UK market, the applicant should provide evidence that an international alternative is representative of the RMP. Further guidance on the suitability of RMPs for generic or hybrid applications and international comparator products can be found here.

Data and Marketing Exclusivity periods (DMEs)

From 1 January 2025, the DME period will be that of the UK product.

Where the UK RMP is a grandfathered EU CAP, the DME which was in effect on 31 December 2020, will apply.

For PLNI applications via the MRP/DCP, the DME periods relevant to the cited ERP will apply. To avoid the possibility of multiple authorisations in the UK for the same product, these applications will only be permitted where an MAH is solely applying for a PLNI through the MRP/DCP and does not have an MAA for a PL or a granted PL for the same product. If an MAA or granted PL were in place, it would need to be withdrawn to enable such an application.

Summary table of future licensing regime

Table 1 provides an overview of the current and future licensing regimes. The right-hand column highlights actions that are required by MAHs in respect to licensing. Conditions of licensing are subject to compliance with the MHRA’s labelling and packaging guidance.

Table 1

	CURRENT POSITION and up to 31   December 2024	FROM 1 JANUARY 2025	ACTION REQUIRED FROM Marketing Authorisation Holders (MAHs)
New Marketing Authorisation Applications (MAA) for product in scope of the Centrally Authorised Procedure (CAP)	PLGB: national   applications, International Recognition applications, ILAP	PL: National applications, International   Recognition route, ILAP	From 1 January 2025, MAHs may apply for PL   licences only. Must comply with labelling and packaging requirements.
New Marketing Authorisation Applications (MAA) for product in scope of the Centrally Authorised Procedure (CAP)	NI: EC authorisation. Supply of GB authorised products   may be permitted through routes, e.g., NIMAR, Reg 174, Reg 167.	PL EC no longer able to authorise for   NI.	From 1 January 2025, MAHs may apply for PL   licences only. Must comply with labelling and packaging requirements.
New MAA for Non-CAP product authorisations	UK-wide authorisation or option to apply for   PLGB or PLNI	PL Or PLNI through the MRP/DCP	From1 January 2025, MAHs may only apply for PL licences, or PLNI if using the Mutual Recognition Procedure/Decentralised   Procedure (MRP/DCP). Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025	UK-wide licence	PL	Must comply with labelling and packaging requirements
Products with existing authorisations granted before 1 January 2025	Separate PLGB and PLNI for the same product.	Option A: PL only	By 30 September 2024 the MAH should inform the   Reference Member State (RMS) of its intention to withdraw NI as a Concerned Member State (CMS) from the MRP/DCP and also request that the MHRA cancel the PLNI, effective on 31 December 2024. PLGB licences will convert to PL on  1 January 2025. Must comply with   labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025	Separate PLGB and PLNI for the same product	Option B: Retain NI only through the   MRP/DCP.	No action required from MAH. PLGB will   be cancelled by the MHRA on 31 December 2024 as cannot hold a PL and PLNI   simultaneously for the same product. Must comply with labelling and   packaging requirements.
Products with existing authorisations granted before 1 January 2025	PLNI through the MRP/DCP, with no PLGB for the   same product	PLNI through the MRP/DCP only	Where a MAH subsequently applies for a PL, the   PLNI will need to be cancelled prior to the granting of the PL. The MAH   should inform the RMS of its intention to withdraw NI as a CMS from the   MRP/DCP. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025	PLGB only	PL only	No action required from MAH. PLGBs will   be converted to PL on  1 Jan   2025. Must comply with labelling and packaging requirements.
CAP  Bridging Mechanism	Permits supply of GB-licensed product in NI for up to 6 months if the MHRA licenses a product before the European Medicines Agency (EMA).	Not applicable as the MHRA will   license novel/CAP medicines in NI through a UK-wide licensing route from 1   January 2025.	No action required from MAH.  PLGBs will be converted to PL on 1 January 2025.

Further information

For further information on the UK-wide licensing of medicinal products, please read our Q&A  which is designed to address common queries, or contact our Customer Services Centre at: 

Email: info@mhra.gov.uk 

Telephone: 020 3080 6000.

1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14. ↩

2. The CAP bridging mechanism remains valid until the end of 2024: See Centrally Authorised Products (CAPs) Bridging Mechanism ↩