The Windsor Framework: UK-wide Licensing Guidance

New UK-wide licensing guidance was issued by the MHRA on 29th September 2023. This provides information on how licencing changes will be implemented when the Windsor Framework takes effect on 1st January 2025.
link to MHRA Guidance

This post captures the key findings from the guidance to help clients with existing or planned UK, GB or NI licences understand their next steps.

Following changes made to EU legislation in April 2022, most products not under the scope of the EU centralised procedure are already able to be authorised UK-wide by the MHRA. The Windsor Framework seeks to extend this position to cover medicines which would fall under the centralised procedure. 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, and all authorised products will be granted as PL licenses.

From 31 December 2024, Marketing Authorisation Holders (MAHs) will not be able to apply for a PLGB license. Existing PLGB licences will automatically convert to PL licences on 1 January 2025, and the category of PLGB will cease to exist. As it will not be possible to simultaneously hold both a PL and a PLGB or PLNI for the same product, action is required by MAHs who hold both PLGB and PLNI for the same product.

To understand your next steps, the first step is to know your terminology.

PL: a product licensed by the MHRA that is authorised in the whole of the UK (England, Scotland, Wales and Northern Ireland).
PLNI: a product licensed by the MHRA that is authorised in Northern Ireland (NI) only.
PLGB: a product licensed by the MHRA that is authorised in Great Britain (GB) only (Great Britain is defined as England, Wales and Scotland).
Products in scope of the CAP: new applications for products that fall under the mandatory or optional scope of the EU centralised procedure, such as new and innovative medicines, orphan medicinal products, Advanced Therapy Medicinal Products (ATMP) and paediatric medicines.
MRP/DCP: Mutual Recognition Procedure/Decentralised Procedure are procedures to obtain a marketing authorisation for the same medicinal product in multiple EU/EEA countries in the same application. Although it is no longer possible to obtain new UK authorisations via this route after Brexit, many UK authorised medicinal products authorised today were first granted via these procedures.
RMP: Reference Medicinal Products are licenced medicinal products that are referenced by generic/hybrid/biosimilar (“copy”) medicine applications to bridge to efficacy and/or safety data.
Impact to PLGB licences (where no PLNI held)
By default, existing PLGBs will automatically become UK-wide PL licences on 1 January 2025.
No action is necessary for this conversion.
Impact to PLGB licences (where PLNI also held)
If the MAH wishes to retain UK-wide authorisation, the PLNI will need to be cancelled. This must be requested by 30 September 2024 at the latest otherwise, the MHRA will automatically cancel the PLGB, meaning that only the PLNI will remain from 1 January 2025.
Impact to PLNI licences (where no PLGB held)
‘PLNI’ will continue to denote medicines that can be supplied to NI only. However, as a PL and PLNI cannot exist for the same product, if a MAH subsequently seeks authorisation for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the PL.
Impact to PL licences under MRP/DCP
For existing UK-wide licences granted through MRP/ 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. Where the MAH currently holds a PLGB and a PLNI (through the MRP/DCP), they will either need to withdraw the PLNI from the procedure in order to convert the PLGB to PL, or cancel the PLGB to retain the PLNI.

Up to 1 January 2025:

  • Applications for UK-wide generics of CAP products will need to cite the CAP as the reference medicinal product (RMP).
  • Non-CAP products can cite a UK-wide licence as a reference product, or a European Reference Product (ERP).

After 1 January 2025:

  • The use of ERPs in UK-wide MAAs will not be possible. It will only be possible to cite ERPs for applications for PLNIs through the MRP/DCP.
  • 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. Where a valid RMP authorised in the UK cannot be established, applications will need to be submitted under a different legal basis e.g., a well-established use 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.

The Data & Market Exclusivity (DME) period will be that of the UK product or the grandfathered EU CAP. For PLNI applications via the MRP/DCP, the DME periods relevant to the cited ERP will apply.

The first important date, if you are a holder of both PLGB and PLNI licences for the same product, is 30 September 2024. By this deadline, you need to have decided which of these licences you wish to convert to UK-wide PL, and which you wish to keep only as PLNI, and have advised the MHRA accordingly. If the MHRA has not received your request to cancel specific PLNI by this date, your corresponding PLGB licences will be automatically cancelled.

The two options are summarised in the table below.

Option: A: Convert PLGB to PL, cancel PLNI B: Retain PLNI only through the MRP/DCP, cancel PLGB
Action required By 30 September 2024 the MAH should request that the MHRA cancel the PLNI, effective on 31 December 2024. No action required from MAH.
Outcome PLGB licences will convert to PL by 1 January 2025. PLGB will be cancelled by the MHRA on 31 December 2024.

The next important date is 1 January 2025, the date on which all PLGB will be converted to UK-wide PL (or cancelled, under Option B above). Note there will be no change to existing licence numbers as part of this conversion: these medicines will retain the same licence number, including the prefix ‘PLGB’.

This is also the date from which all licences must comply with the new labelling and packaging requirements, as outlined in this guidance, although it should be noted that existing stock in existing packaging, which was released to the market prior to 1 January 2025 can continue to be supplied until the product’s date of expiry.

The next important date is 1 January 2025, the date on which all PLGB will be converted to UK-wide PL (or cancelled, under Option B above).  Note there will be no change to existing licence numbers as part of this conversion: these medicines will retain the same licence number, including the prefix ‘PLGB’.

This is also the date from which all licences must comply with the new labelling and packaging requirements, as outlined in this guidance, although it should be noted that existing stock in existing packaging, which was released to the market prior to 1 January 2025 can continue to be supplied until the product’s date of expiry.


It is very important to fully understand the changes being made here, as there are potentially significant impacts to not only labelling but also supply routes, pack-sharing and falsified medicines safety features. Notification of changes to MHRA will also be required ahead of the implementation deadline. Careful consideration will be needed to identify the best way of introducing these changes for your product portfolio(s), well ahead of this deadline.

To learn more, please read our post on Windsor Framework labelling guidance here.


After 1 January 2025, all new products in scope of the CAP will be granted PL licences only. Products outside the scope of the CAP will also be granted PL licence, except where only a PLNI is applied for under MRP or DCP. Note that where only a PLNI is held through MRP/DCP, if an MAH subsequently applies for a PL, the PLNI will need to be cancelled prior to the granting of the PL.

Two other key guidance impacts relating to Northern Ireland are the CAP Bridging Mechanism, which will cease to exist from 1 January 2025, and the Northern Ireland MHRA Authorised Route (NIMAR), which will remain in place in law, but is anticipated to no longer be required after the commencement of the Windsor Framework. NIMAR was put in place as a route of supply for essential medicines into Northern Ireland from mainland UK (GB) where no authorised medicines are valid in Northern Ireland (e.g. in situations where PLGB only exists).

We can support you by providing bespoke guidance for your product portfolio as required depending on the current and new licensing arrangements.

We can also support with the submission of PLNI cancellation requests or “UK only” labelling changes, and provide guidance on the most efficient regulatory strategy to fit around your planned submissions.

Jenson R+ will be attending the upcoming Windsor Framework webinar hosted by DHSC on Thursday 26th October 2023, and will share any further details or updates with clients as relevant.

Nicola Gover
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