Your Guide to The Windsor Framework:
Key Changes and Business Impact

Summary

With the commencement of the Windsor Framework on 1 January 2025 marketed medicines will need to display the statement “UK Only” and should no longer apply the EU Falsified Medicines Directive (FMD) to applicable* packs licensed in Northern Ireland. (Note PLGB Marketing Authorisations (MAs) already disapplied the EU FMD, so this requirement applies to applicable* UK-wide & NI MAs).

The Medicines and Healthcare products Regulatory Agency (MHRA) must be notified that these changes have been introduced before the end of 2024. The MHRA has now contacted Marketing Authorisation Holders (MAHs) to advise them of industry progress and to request that where notification has not yet occurred, that this should happen sooner rather than later, to avoid a “bottleneck” caused by a large number of submissions to the MHRA late in 2024.

*i.e., most prescription medicines; EU FMD does not apply for most non-prescription medicines.

The MHRA have communicated that there are approx. 19,000 MAs that will need to be updated and as of 14 May 2024 the MHRA had only received submissions in relation to 20%. The MHRA have requested that the submissions be made as soon as possible. They have also said that the Department for Health and Social Care (DHSC) will be surveying MAHs to gain an understanding of industry readiness.

“UK Only” (or “UK only”) must appear on the carton, or in the absence of a carton, on the immediate container label; it is not required on inner labelling, blister foils or the leaflet. It only needs to appear once on the outer packaging, the font used must be conspicuous and legible with a minimum of 7 points in size; the exact location on the outer packaging is not specified (other than in the case where the outer labelling is a “peel and read” label/leaflet that “UK Only” is visible on the outer visible part of the label).

The notification of “UK Only” to the labelling (along with the removal of EU FMD features where applicable) can be made in one of three ways:

1. As part of another regulatory procedure (except Type IA variations), including those that did not otherwise impact the labelling (submission in eCTD format by 31 December 2024**) – no additional fee.
2. As a BROMI notification (submission in eCTD format by 31 December 2024) – notification fees apply.
3. Self-notification without eCTD before 1 January 2025, followed by an eCTD submission as per options 1 or 2 above but with a deadline of 31 December 2025 – notification fees apply for the first submission and again for the second when option 2 is used.

**The changes can’t be implemented until formal approval is received for the associated procedure, therefore option 1 should only be used where realistically the procedure will be approved before 1 January 2025.

Although the Windsor Framework comes into effect as of 1 January 2025, and therefore the deadline for submission of the updated artwork is 31 December 2024, it is in the interest of MAHs and the MHRA that these submissions are made well ahead of this date. Submission can be made immediately for all licence types, and “UK Only” can be introduced onto packaging for PLGB & PL MAs following the submission of the self-certification (options 2 & 3) or following the approval of the associated regulatory submission (option1); for PLNI MAs with “UK Only” can only be released to market from the 1 January 2025.

Disapplication of EU FMD features, where they are currently applied, can only happen from 1 January 2025; as these are variable elements printed during packaging they should not prevent/hold up the introduction of “UK Only”.

The usual 6-month implementation period for self-certification does not apply, “UK Only” will need to be on packs released to market from 1 January 2025.

Until 30 June 2025 it will be possible to apply the “UK Only” statement by “sticker” (subject to certain stipulations), the position of this sticker still needs to be notified to the MHRA as per options 1, 2 & 3 above; it is not necessary to make another submission when “UK Only” is printed directly onto outer packaging labelling.

In relation to the 3 options available:

  1. 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. 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.
  2. “UK Only” can be introduced immediately following submission and before the 1 January 2025 deadline (with the exception of PLNI MAs). The usual 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.
  3. Cover letter and self-notification application form along with updated labeling mock-ups are supplied via the MHRA Submissions Portal. This will need to be followed by either option 1 or 2 during 2025, and if BROMI notification is used then fees for notification will be charged again.

Clean mock-ups showing the actual position of “UK Only” on the outer packaging can be supplied, it is worth noting that for all 3 options, where the only change being made is the addition of “UK Only”, clean mock-ups are not required, instead annotated mock-ups indicating the position of “UK Only” are acceptable; when clean mock-ups are next supplied to the MHRA to introduce changes to the labelling, then they can introduce “UK Only”.

How JensonR+ can support you

The expert team at JensonR+ can support you by providing bespoke guidance for your product portfolio as required, depending on the current licensing arrangements and legal classification of supply. We can also support with the submission of the “UK only” labelling change and provide guidance on the most efficient regulatory strategy to fit around your existing submissions.
Get in touch with us at consultancy@jensongroup.com

Neil Prideaux
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