Windsor Framework: Upcoming Changes to Medicinal Product Packaging and Labelling

The recently introduced Windsor Framework discusses changes to the packaging and labelling requirements for medicinal products for human use within the UK. These changes, effective from 1 January 2025, aim to ensure that medicines destined for the UK market are clearly distinguished from those intended for the European Union (EU) market. This blog post provides a comprehensive overview of the new requirements and steps that Marketing Authorisation Holders (MAHs) need to take to ensure compliance.

Key Changes

To prevent the onward movement of UK-specific medicines into the EU and maintain uniform packaging across the UK, all medicinal products on the UK market must bear a ‘UK Only’ label. These measures come into effect on 1 January 2025, and the specific changes include:

1. Authorisation Changes:
   • All new medicines and those currently falling under the EU Central Authorisation Procedure in Northern Ireland will be authorised by the MHRA for the UK market.
   • These products will only be available in the UK and will not be marketed in Ireland or elsewhere in the EU, except as ‘specials’ under EU rules and conditions​​.
2. Packaging Requirements:
   • Packaging for all products for the UK market must feature a clearly legible ‘UK Only’ label.
   • A transitional period allows for the use of ‘UK Only’ stickers until 30 June 2025. After this date, the label must be printed on the packaging​​.
3. Compliance Deadlines:
   • MAHs must submit updated packaging artwork with the ‘UK Only’ label to the MHRA by 31 December 2024, though earlier submissions are encouraged​​.
   • The ‘UK Only’ label can be used as soon as the submission is done, without waiting for 1 January 2025​.
4. Additional Labelling Details:
   • From 1 January 2025, the Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland for UK-only packs. Any existing 2D barcodes related to EU Regulation 2016/161 must be removed or covered. However, the use of anti-tampering devices remains encouraged by the MHRA.
5. Existing Stock:
   • Stock placed on the market prior to 1st January 2025 in Northern Ireland and Great Britain under the current rules can continue to be supplied until their expiry date​.

Steps for Compliance

To ensure compliance with the new requirements, MAHs should:

1. Update Packaging Artwork:
   • Submit updated packaging artwork featuring the ‘UK Only’ label to the MHRA as soon as possible, and no later than 31 December 2024.
   • Ensure the ‘UK Only’ label is clearly visible and complies with MHRA guidelines​.
2. Transitional Arrangements:
   • Utilize ‘UK Only’ stickers for a transitional period until 30 June 2025. Ensure that these stickers do not cover any existing information on the pack and are applied under GMP compliance at the site named on the MA.
   • Provide a mock-up of the outer packaging to the MHRA, indicating where the sticker will be placed​​.
3. Remove EU-Specific Features:
   • Ensure that any 2D barcodes related to EU regulations are removed or covered by 1 January 2025.
   • Continue to encourage the use of anti-tampering devices, as per MHRA recommendations​.

The Windsor Framework introduces important changes that aim to streamline the packaging and labelling of medicinal products within the UK while preventing their unintended movement into the EU. MedTech companies must act promptly to ensure compliance with these new requirements. For tailored advice and support with your compliance needs, explore our experts at SwiftGxP.

For further guidance, you can refer to the official documents:

• UK-wide Licensing for Human Medicines​
• Labelling and Packaging of Medicinal Products Following Agreement of the Windsor Framework​