The Windsor Framework: Labelling and Packaging Guidance

New labelling and packaging guidance was issued by the MHRA on 28th July 2023. This sets out how to implement the labelling and packaging requirements for medicines in line with the Windsor Framework.

link to MHRA Guidance

Quick summary of the Winsor Framework for medicines:

This framework sets out the long-term arrangements for the supply of medicines into Northern Ireland. It will ensure that medicines can be approved and licensed on a UK-wide basis and provides for the disapplication of EU Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied in Northern Ireland.  To preclude onward movement of these medicines into any part of the EU, whilst ensuring medicines can use the same packaging and labelling across the UK, all medicines on the UK market must be labelled as ‘UK Only’.

Up until now, there has been no practical guidance on how these changes are implemented.

Marketing Authorisation Holders of Current PL Licences (UK-wide) – Prescription Medicines

From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. From 1 January 2025 features included for the purposes of compliance with EU FMD requirements may be removed. Prior to 31st December 2024 the “UK only” label must be submitted to the MHRA.

Marketing Authorisation Holders of Current PL Licences (UK-wide) – Non-Prescription Medicines

Prior to 31st December 2024 the “UK only” label must be submitted to the MHRA.

Marketing Authorisation Holders of PLGB Licences (Great Britain)

The territorial extent of existing GB-only licences will be converted to UK-wide. Packs for those current PLGB licences that are to become UK-wide licences from 1 January 2025 must continue to present the PLGB number on the pack in addition to the ‘UK only’ statement. Further guidance is to be provided on this.

Marketing Authorisation Holders of PLNI Licences (Northern Ireland)

There will be further guidance published on the impact of the licensing aspects of PLNI authorisations. From 1 January 2025 features included for the purposes of compliance with EU FMD requirements may be removed. Prior to 31st December 2024 the “UK only” label must be submitted to the MHRA.

Marketing Authorisation Holders with Joint EU/UK Packs

From 1 January 2025, joint EU/UK packs can no longer enter the supply chain. A joint pack is one that is shared with another European country or countries, and which 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 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.

Applicants of new marketing authorisation applications

For Marketing Authorisation applications 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.

Early implementation of labelling (i.e. before 1 January 2025) will be permitted as described in the section ‘Early Implementation’ above. Marketing Authorisation applications made after 1 January 2025 will need to include labelling mock-ups and/or labelling text, presenting the ‘UK Only’ statement, on submission.

Businesses in the EU currently relying on using a single English language pack distributed from the UK

These businesses should contact their suppliers and ensure that appropriate preparations are being made for their supply.

Parallel Importers

From 1 January 2025, all Parallel Imports (PLPIs) will be authorised to be marketed in the UK. Any PLPIs with a current territorial limitation of ‘GB’ will be converted to UK-wide authorisation. Further guidance on the arrangements for transitioning licences is to be provided.

PLPI companies should therefore not include ‘GB’ on the packaging materials of products entering the UK supply chain from 1 January 2025. PLPIs do not require a ‘UK Only’ label to be applied to packs. PLPIs will not need to comply with the EU FMD requirement (see the ‘Disapplication of FMD safety features’ section above). No assessment and no application submission would be required. From the date of publication of this guidance, companies can apply the UK ONLY label for licences valid in the UK, and the MHRA are giving further consideration to the publication of specific guidance for PLPIs.

Licence Do FMD requirements currently apply? Use of ‘UK Only’ label: (Earliest submission date for addition of ‘UK Only’ label) Use of ‘UK Only’ label: (Latest submission date for addition of ‘UK only’ label) Use of ‘UK Only’ label: (Earliest date that packs with ‘UK only’ label can be released to market) FMD disapplied: Date of disapplication of FMD
UK-wide Product Licence (PL) – Prescription Yes (most prescription medicines) Immediately 31 Dec 2024 From date of guidance publication From 1 Jan 2025
UK-wide Product Licence (PL) – Non-prescription No (for most non-prescription medicines) Immediately 31 Dec 2024 From date of guidance publication N/A
GB Product Licence (PLGB) No Immediately 31 Dec 2024 From 1 Jan 2025* N/A
NI Product Licence (PLNI) Yes From date of licensing guidance publication 31 Dec 2024 31 Dec 2024 From 1 Jan 2025

*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.

New measures

From 1st January 2025 the following measures will commence:

  • All new medicines that currently fall under the scope of the EU Central Authorisation Procedure will be authorised by the MHRA for the UK market (rather than Northern Ireland forming part of EU procedure). Separate guidance will be published on the licensing process.
  • These products will only be able to be sold in the UK and will not be available on the market in Ireland or elsewhere in the EU, other than available in the EU as ‘specials’ subject to EU rules and conditions.
  • Packaging for all products, for the UK market must carry a clearly legible ‘UK Only’ label for the product to be allowed onto the UK market (except products with a parallel import licence (PLPI), which have the option to add the label).
Existing Stock

Any stock in existing packaging already placed on the market in Northern Ireland and Great Britain (GB) (in accordance with the relevant rules in Northern Ireland or GB) up until that date (i.e. released by a Qualified Person (QP)) can continue to be supplied to patients until the date of their expiry.

Implementation of the UK Label

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.

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.

Guidance for stickering:
  • 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 notification process for providing updated mock-ups is described in the section ‘Notification Process’ later in this guidance document. There is no need to register an updated mock-up when the ‘UK Only’ label is subsequently printed directly on the pack. Updated labelling may be provided at the next regulatory opportunity.

PLPI products will be unaffected by this guidance, and stickering and over labelling will still be allowed for these products.

FMD Safety Features

From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. From 1 January features included for the purposes of compliance with EU FMD requirements may be removed.

All existing safety requirements under UK law, for instance on the placement of the expiry date and batch number and other packaging requirements, remain unchanged. In addition, under UK law, MA holders may choose to apply the following features on UK packaging, although this is not compulsory:

  • a 2D barcode (Data Matrix), which may encode data including information about the specific medicinal product, the expiry date, batch number, Global Trade Item Number, and serial number if applicable; and
  • a serial number of any format.

The MHRA will still continue to encourage companies to use anti-tamper packaging.

All such information or features will fall under the terms of UK law. If a pack carries a 2D barcode, there are no restrictions on the coding scheme that is used, provided it can be decoded using common scanning equipment; it is anticipated that barcodes would conform to common ISO/IEC standards. The presence of a 2D barcode encoding an alphanumeric character sequence (as referred to in EU Regulation 2016/161) that has been uploaded to the European repositories system is prohibited and if present would need to be to be fully removed or covered.

Early implementation

Ahead of the 1 January 2025 commencement date, updates to labelling and packaging can start to be made from the date of publication of this guidance and will be permitted for UK-wide Product Licences (PLs) and GB Product Licences (PLGBs) only:

  • PLs: ‘UK Only’ label can be applied to the outer packaging before 1 January 2025 but the packs will need to remain compliant with EU FMD requirements where these apply until this date.
  • PLGBs: While packs can be updated earlier, products bearing ‘UK Only’ will only be able to become available UK-wide on 1 January 2025, and cannot be released to the market in either GB or NI before that date. Further guidance on the arrangements for transitioning licences is to be provided.
Notification process

Before implementing any new artwork changes, companies must notify the MHRA and have until 31 December 2024 to do so. There are two ways in which companies can notify the MHRA of artwork changes:

  • Marketing authorisation holders (MAHs) can utilise any available regulatory opportunity, except Type 1A variations, to submit the artwork change in conjunction with another application, such as a variation. No additional fee would be required for the artwork change. MAHs choosing this route of submission must ensure that the cover letter and 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. For companies wishing to submit in bulk to notify an update to their portfolio, the usual guidance on bulk submission will apply, with a limit of 25 licences per bulk application.
  • Through self-certification, companies can submit a separate notification specifically for the artwork change to be tracked through the MHRA’s regulatory management system. For this option, MAHs can implement the proposed changes once the application has been submitted rather than wait for formal approval, provided the changes are in line with the guidance. The usual implementation timeline of 6 months does not apply to this change and companies are able to implement updated cartons at any time as long as this is 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.

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 labelling components must be updated in a single submission. This may be via either of the options above.

For both options 1 and 2 above, where the only change being made to the label is 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 opportunity where the label is being updated. No other changes to the label apply in this type of application.

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, companies are expected to manage their own readiness for market. The notification process is a requirement of Regulation 267 of the Human Medicines Regulations 2012.

We 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.

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.

Lauren Foster
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