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The medicines arrangements under the Windsor Framework came into effect on 1 January 2025. This is a reminder about the approaching deadline for the use of ‘UK Only’ stickering, and an update on recent MHRA publications to supplement existing guidance.
- Option to apply ‘UK Only’ stickers ends on 30 June 2025
- Category 1 list of medicines updated and new Category 2 list of medicines published
- Recent publications
- Contact us regarding implementation concerns
The ‘UK Only’ statement can only be applied to medicines via a sticker until 30 June 2025. After this date, ‘UK Only’ must be printed directly onto packaging. If you are currently using stickering it is important to ensure you are ready for ‘UK Only’ to be printed on packs from 1 July 2025. Stickers will not be accepted for products released to market from 1 July 2025.
Products with ‘UK Only’ stickering that have been QP certified before 1 July 2025 can continue to be supplied to patients until the date of their expiry.
Parallel Import (PLPI) products are not affected and can continue using stickers and over labelling.
If you have medicines on the UK market with a ‘UK Only’ sticker, you should have already submitted a notification (updated mock-up) indicating the sticker’s location on the outer packaging. This means you don’t need another labelling submission when transitioning from stickering to printing directly on cartons. You can switch to the updated packaging before 1 July 2025 without submitting another notification. Any further updates to labelling can be provided at the next regulatory opportunity.
Stickering guidelines
If you plan to use stickering before 1 July 2025, please note the following:
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Before Certification: The ‘UK Only’ sticker must be applied before certification by a Qualified Person (QP) and must be done at the site named on the Marketing Authorisation (MA).
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Existing Packs: Packs released before 1 January 2025 do not need a sticker or over label.
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Sticker Placement: The sticker must not cover any statutory text (e.g. batch numbers or expiry date).
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Mock-ups: If you are using stickers to initially apply ‘UK Only’, you must provide an updated mock-up of the outer packaging to the MHRA, showing the sticker's placement. However, no updated mock-up needs to be registered when the ‘UK Only’ label is subsequently printed directly on the pack.
For further information on applying the ‘UK Only’ statement and using stickering, please see our guidance on labelling and packaging of medicinal products for human use following agreement of the Windsor Framework, including the stickering section of our Q&A document. You can also email the MHRA at patient.information@mhra.gov.uk with more general questions about labelling requirements. See section 4 below regarding any concerns about implementation.
The Category 1 list of medicines has now been updated to include authorisations granted during December 2024. It also includes medicines that had not been assigned to Category 1 when the initial list was compiled.
Any authorisations that have been cancelled since publication of the initial list will not appear in the updated list.
The Category 2 list of medicines has now been published. It contains a list of currently authorised products that had an authorisation in effect on 31 December 2024 which have been assigned to Category 2.
We have published the following supplementary guidance and Q&As to further assist companies and address common queries:
If Marketing Authorisation Holders have concerns regarding the implementation of the new arrangements on human medicines under the Windsor Framework, contact us at partnerships@mhra.gov.uk so we can discuss your case further. We have supported several companies to reach a compliant pathway.
Thank you,
The Medicines and Healthcare products Regulatory Agency
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