This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines.
Key Responsibilities for Marketing Authorization Holders (MAHs)
Marketing Authorization Holders must communicate any changes to manufacturers promptly. This is crucial to ensure that all batches produced have the correct labelling and product information.
This guidance should be read alongside the labelling and packaging instructions and relevant Q&As.
Overview of the Windsor Framework
The Windsor Framework outlines long-term strategies for the supply of medicines in Northern Ireland, enabling human medicines to receive approval and licensing on a UK-wide basis through the MHRA. It also disapplies the European Union (EU) Falsified Medicines Directive (FMD) safety features for medicines marketed in Northern Ireland.
To prevent the onward movement of these medicines into the EU or European Economic Area (EEA), all medicines on the UK market must be labelled as ‘UK Only’.
Implementation Timeline
These new measures will take effect on 1 January 2025. Key points to note include:
1. All new medicines and those currently under the EU Centralized Authorization Procedure in Northern Ireland will be authorized by the MHRA for the UK market.
2. These products will only be available in the UK and lawful export markets; they will not be accessible in Ireland or elsewhere in the EU.
3. All packaging for UK market products must prominently display a ‘UK Only’ label. Stickering is permitted until 30 June 2025.
4. Joint packs between the UK and EU will be discontinued.
5. PLGB licenses will transition to UK-wide Marketing Authorizations from 1 January 2025.
Labelling and Packaging Requirements for QPs
Starting 1 January 2025, all human medicinal products in the UK, including Prescription Only Medicines and General Sales List products, will be required to display a clear ‘UK Only’ label. This requirement also applies to parallel imported products. Existing stock that has already received QP certification can continue to be supplied until it reaches its expiry date.
The ‘UK Only’ label must be prominently placed on the outer packaging, ensuring it is legible and indelible. The font size should be at least 7, in line with current MHRA guidelines, and for larger products, visibility is especially important.
Until 30 June 2025, the ‘UK Only’ label may be applied using an indelible sticker. After this date, the label will need to be printed directly on the packaging. For products that are imported without the ‘UK Only’ label, local stickering is allowed before QP certification.
Guidance for Northern Ireland and Export Activities
The Northern Ireland MHRA Approved Route (NIMAR) ensures that patients in Northern Ireland can access prescription-only medicines when authorized products are unavailable. As new measures are implemented, many PLGB licensed products may no longer require inclusion on the NIMAR list.
Starting 1 January 2025, all new packs must include ‘UK Only’ labelling, which does not restrict exports to compliant countries outside the EU.
Responsibilities for RPis
Wholesale dealers in Great Britain must import QP certified medicines only from approved countries. Compliance with MHRA guidance is crucial for all imported goods post-31 December 2024.
Conclusion
This guidance provides critical information for manufacturers, wholesale dealers, and authorized personnel to navigate the changes resulting from the Windsor Framework. By adhering to these regulations, stakeholders can ensure the smooth supply of human medicines across the UK while maintaining compliance with all legal requirements.
