Labelling and packaging of medicinal products for human use

Last updated 5 April 2024

This guidance provides 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 1 January 2025. This means that from this date

• All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Central Authorisation Procedure will be authorised by the MHRA for the UK market. See further guidance on the transition of licences.
• 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.

‘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 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.

Stickering

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

• 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. 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.

Disapplication of FMD safety features and encoding of pack information under UK law

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 or covered.

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.

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.

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.

All new packs placed on the UK market on or after 1 January 2025 must display ‘UK Only’ label.

Early release to market

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

UK-wide MAs

• The ‘UK Only’ label can be applied to packaging and released to the UK market before 1 January 2025.
• UK-wide MA packs will need to remain compliant with EU FMD requirements until 31 December 2024 and be disapplied from 1 January 2025.

PLGBs

• 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.
• 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.

Notification process

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 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 opportunity 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.

New Marketing Authorisation applications

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.

Early implementation of labelling (i.e. before 1 January 2025) will be permitted. MAAs made after 1 January 2025 will need to include labelling mock-ups and/or labelling text, presenting the ‘UK Only’ statement, on submission.

Traditional Herbal (THR) and Homeopathic (NR and HR) medicinal products

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 the labelling and packaging for traditional herbal and homeopathic medicinal products 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, 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. 

PLPI licence holders should therefore not include ‘GB’ on the packaging materials of products entering the UK supply chain from 1 January 2025.  

All PLPIs must include ‘UK Only’ on their packaging from 1 January 2025. This includes PLPI licences with a current UK territory. 

PLPIs will not need to comply with the EU FMD requirement. See further guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework.

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.

PLGB licence numbers

The territorial extent of existing GB-only licences will be converted to UK-wide from 1 January 2025. The change in territorial scope of a licence does not require a change in licence numbers. 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. Read more about UK-wide licensing guidance.

Further information

For further information on the labelling and packaging of medicinal products, please read the Q&A which is designed to address common queries, or contact the Customer Services Centre at 

Email [email protected] 

Telephone 020 3080 6000.