The Windsor Framework is a post-Brexit legal agreement between the European Union and the United Kingdom which adjusts the operation of the Northern Ireland Protocol. The Framework was announced on 27 February 2023, formally adopted by both parties on 24 March 2023 and came into effect on 1 October 2023. The UK Government announced plans for revisions to the Framework’s operation in January 2024.
The Framework was negotiated to address political concerns in the UK and especially among Ulster Unionists about the Northern Ireland Protocol. Under the terms of the Protocol, Northern Ireland, unlike the rest of the UK, remains in the EU single market for goods. This puts in place a de facto Irish Sea trade border for goods moving to Northern Ireland from Great Britain.
The Framework changes aspects of the Protocol’s operation, particularly to ease custom checks on goods arriving from Great Britain. It gives the UK government more control over VAT rates applying in Northern Ireland and states that medicines placed on the market in Northern Ireland will be regulated by the UK and not the EU. It gives the Northern Ireland administration and UK government a mechanism to object to, pause, and potentially disapply updated and amended EU laws, mainly concerning goods.
‘UK Only’ label requirements
From 1 January 2025, in order to enable medicines to use the same packaging and labelling across the UK, packaging for all UK medicinal products (Prescription Only Medicine and Pharmacy and General Sales List) must carry a clearly legible ‘UK Only’ label to be placed on the UK market.
When using the ‘UK Only’ label on packaging, the following will apply:
- ‘UK Only’ may be presented anywhere on the outer packaging of the medicine.
- The text must be conspicuous and clearly legible, at least 7-point font and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations and best practice guidance.
There are no other font or style requirements other than those stated above. To provide a single deadline for new packaging requirements, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024. This extends the previous 31 December 2023 deadline, which required medicines for GB to be presented in GB compliant packaging, by one year. The table below indicates the eligible territory for the supply of packs before and after 1 January 2025.
The ‘UK Only’ statement can be applied via a sticker for a limited time period of 6 months, to 30 June 2025. After this date, ‘UK Only’ must be printed directly onto the packaging. Stickering will not be accepted after this date. PLPI products will be unaffected by this guidance, and stickering and over labelling will still be allowed for these products.
The guidance for stickering is as follows:
- The application of a ‘UK Only’ sticker will need to be done prior to certification by a Qualified Person (QP). The stickering must be completed by the site named on the Marketing Authorisation (MA) prior to QP Certification. Packs released prior to 1 January 2025 can remain without the need to use a sticker or over label.
- The sticker must not cover any statutory text presented on the pack (e.g. batch numbers and expiry date).
- MA holders who initially wish to apply the ‘UK Only’ statement by means of a sticker will need to provide an updated mock-up of the outer packaging to the MHRA, indicating where this will be placed on the carton.
The ‘UK Only’ label can be applied to packaging and released to the GB market before 1 January 2025. PLGBs are not required to have FMD features but for avoidance of doubt, after 1 January 2025, PLGB packs must meet the requirements set out in section 6 (disapplication of FMD safety features). QP-released PLGB packs meeting these requirements will be valid for immediate supply to the Northern Ireland market after 1 January 2025. QPs should have mechanisms in place to ensure PLGB packs meet these FMD requirements prior to release.
Supply of existing stock in existing packs
Any stock in existing packaging already placed on the market in Northern Ireland and GB (in accordance with the relevant rules in Northern Ireland or GB (i.e. released by a Qualified Person (QP) up until that date) can continue to be supplied to patients in the relevant territory until the date of their expiry. This means that until the date of expiry of the pack:
- PLGB packs released prior to 1 January 2025 and on the Northern Ireland MHRA Authorised Route (NIMAR) list can be supplied in their existing packaging to GB and Northern Ireland.
- PLGB packs released prior to 1 January 2025, but not on the NIMAR list, can continue to be supplied in their existing packaging to GB only.
Before implementing any new artwork changes, companies must notify the MHRA and have until 31 December 2024 to do so. There are three ways in which companies can notify the MHRA of artwork changes:
- Any regulatory opportunity
Use any available regulatory opportunity to submit the artwork change in conjunction with another application, such as a variation (except Type 1A variations). No additional fee would be required for the artwork change. MAHs choosing this route of submission must ensure that the cover letter and application form include a statement that the labelling has been updated in accordance with the Windsor Framework requirements. For this option, MAHs must wait until they receive formal approval for the procedure before implementing the updated artwork. Guidance on notification(s) will apply, with a limit of 25 licences per bulk application.
- Self-certification
Submit a separate self-certification notification specifically for the Windsor Framework artwork change to be registered and tracked through the MHRA’s regulatory management system. For this option, provided the changes are in line with the guidance, MAHs can implement the proposed changes once the application has been submitted rather than wait for formal approval. The usual implementation timeline of 6 months does not apply to this change and companies are able to implement updated cartons at any time before the 1 January 2025 deadline. The usual fees for self-certification and guidance on bulk submissions will apply. This process applies to ‘UK Only’ being added to the pack via a sticker (see ‘Stickering’ section earlier in this guidance document) or printed directly onto the pack.
- Self-certification without initial Electronic Common Technical Document (eCTD)
MAHs can initially submit artwork changes without an updated eCTD sequence by 31 December 2024, and then have until 31 December 2025 to submit an updated eCTD sequence. Guidance on bulk submissions and the usual fees for self-certification will apply.
This can be done using the following two-step process:
Step 1: Submit a self-certification notification without an updated eCTD sequence by 31 December 2024. This can be made through the MHRA portal and should include:
- a cover letter, indicating that the proposed artwork change is being submitted to meet Windsor Framework requirements,
- an application form, and
- the labelling mock-up (PDF) in the working documents folder.
The usual fees for self-certification will apply.
Step 2: Submit the updated eCTD sequence, including the updated labelling artwork by 31 December 2025 either as part of:
- another regulatory procedure, or
- via a self-notification where the usual fee will apply.
Where more than one set of labelling is approved on a licence (for example own-label suppliers or a product marketed under more than one name), all updated labelling components must be submitted in a single submission.
For all options 1, 2 and 3 above, where the only change being made to the label is the addition of the ‘UK Only’ statement, an annotated mock-up indicating where this wording will be located is acceptable. A clean mock-up is not required. This can be submitted at subsequent regulatory opportunities where the label is being updated. If you are submitting via option 1 and additional consequential changes to your label are proposed, then an updated clean mock-up (i.e. no annotation) is required.
In deciding which notification process to use, MAHs are expected to manage their own readiness for market. The notification process is a requirement of Regulation 267 of the Human Medicines Regulations 2012.
For Marketing Authorisation Applications (MAAs) under assessment, labelling mock-ups and/or labelling text including ‘UK Only’ can be approved as part of the licensing procedure. For some applications, this will mean updating the labelling mock-ups and/or text originally provided with the submission during the procedure.
Packaging for all UK Homeopathic (NR) medicinal products should state ‘UK Only’ in line with the requirements stated in this guidance. UK Herbal (THR) and Homeopathic (HR) medicinal products do not require a ‘UK Only’ label to be applied to packs but have the option from the date of publication of this guidance, to apply the ‘UK Only’ label for consistency. This should be done in line with the process stated in this guidance.
Updates to packaging and health and herbal products labels can be made following option 1 of the Notification process above. Options 2 and 3 of the Notification process does not apply to THRs, NRs and HRs and the below options may be followed: For THRs, an external information update may be submitted. A THR Administrative fee will apply. For NRs and HRs, a variation application (“other application where no further medical, technical or scientific assessment is required”) may be submitted. The usual fee will apply.
Parallel Imports (PLPI) Packs
From 1 January 2025, joint EU/UK packs can no longer be released to the UK supply chain. A joint pack is one that is shared with another EU country or countries that presents administrative details for both the UK and the other markets sharing the pack. Information relevant to other markets will need to be removed from the outer cartons for these packs when the ‘UK Only’ statement is added, and these changes should be made within the same submission. Packs already released to market may, however, continue to be supplied until their expiry date. Shared inner packaging components, such as multi-lingual blister foils and joint leaflets may continue to be used, provided that the UK and EU licences remain aligned.
Joint EU/UK packs
From 1 January 2025, joint EU/UK packs can no longer be released to the UK supply chain. A joint pack is one that is shared with another EU country or countries that presents administrative details for both the UK and the other markets sharing the pack. Information relevant to other markets will need to be removed from the outer cartons for these packs when the ‘UK Only’ statement is added, and these changes should be made within the same submission. Packs already released to market may, however, continue to be supplied until their expiry date. Shared inner packaging components, such as multi-lingual blister foils and joint leaflets may continue to be used, provided that the UK and EU licences remain aligned.
