UK-Wide Labelling and Packaging Requirements After Windsor Framework

Introduction

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on labelling and packaging of medicinal products for human use following the agreement of the Windsor Framework. This guidance explains how new regulatory arrangements affect the presentation of medicines throughout the UK from 1 January 2025, ensuring consistency in packaging and labelling across all territories of the UK.
Source: Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework (gov.uk)

The Windsor Framework sets out long-term arrangements for the supply of medicines into Northern Ireland (NI), allowing medicines to be licensed UK-wide by the MHRA and removing the need for separate EU-aligned labelling in NI.
Source: Labelling and packaging of medicinal products … (gov.uk)

‘UK Only’ Labelling Requirement

From 1 January 2025, all medicinal products for human use placed on the UK market must be labelled and packaged with a clearly legible ‘UK Only’ designation on the outer packaging to indicate that they are exclusively for the UK market and not for onward supply into the European Union (EU).
Source: Labelling and packaging … (gov.uk)

This requirement applies to all categories of medicinal products, including prescription medicines, pharmacy medicines, and general sales list products. The labelling must be conspicuous and legible to comply with MHRA expectations.
Source: Labelling and packaging … (gov.uk)

Transitional Arrangements

Medicine packs already released to the market before 1 January 2025 without the ‘UK Only’ label may continue to be supplied until their expiry date. For packs manufactured after that date, products must bear the required labelling before being placed on the UK market.
Source: Labelling and packaging … (gov.uk)

For a limited period until 30 June 2025, the MHRA allows the ‘UK Only’ designation to be applied using a sticker on the outer packaging as an interim compliance measure. After this period, the designation must be printed directly on the packaging itself.
Source: Pharma industry guidance

Disapplication of EU FMD Requirements

The Windsor Framework disapplies the EU Falsified Medicines Directive (FMD) requirements for products supplied in Northern Ireland, meaning UK packaging no longer needs to include EU-compliant safety features like unique identifiers linked to EU repositories.
Source: Windsor Framework Explainer

Although the FMD features are removed, the MHRA encourages anti-tamper devices such as 2D barcodes on packaging where commercially appropriate, provided they do not conflict with the disapplication of EU systems.
Source: Advisory guidance

Practical Advice for Manufacturers and Wholesalers

Marketing Authorisation Holders (MAHs) and packagers must ensure that artwork and packaging updates reflecting the new UK-wide requirements are planned and submitted to the MHRA in a timely manner. Transitional provisions allow for legacy stock to be sold, but newer stock must meet the updated labelling standards.
Source: Information for pharmacists and medicines procurers

Conclusion

The Windsor Framework guidance on labelling and packaging for medicinal products for human use aims to create a single, consistent UK regulatory approach from 1 January 2025, replacing multiple pre-existing labelling regimes and ensuring that all medicinal products in the UK share the same packaging and labelling standards.
Source: Labelling and packaging … (gov.uk)