Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework

Nov 25, 2023

Published 28 July 2023

© Crown copyright 2023

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework

This guidance is designed to provide information on the implementation of labelling and packaging requirements for medicinal products for human use following agreement of the Windsor Framework.

The Windsor 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 by the Medicines and Healthcare products Regulatory Agency (MHRA) and provides for the disapplication of European Union (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 European Union (EU), while ensuring medicines use the same packaging and labelling across the UK, all medicines on the UK market must be labelled as ‘UK Only’.

These measures will commence on 1 January 2025[footnote 1]. This means that from this date:

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.

Businesses in the EU currently relying on using a single English language pack distributed from the UK, should contact their suppliers and ensure that appropriate preparations are being made for their supply.

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:

There are no other font or style requirements other than 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 ‘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.

Guidance for stickering:

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:

We 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.

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:

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:

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.

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.

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 will be made available in due course.

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.

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.

The territorial extent of existing GB-only licences will be converted to UK-wide. Further guidance will be provided on this. 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.

For further information on the labelling and packaging of products, please email [email protected]

Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14. ↩