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Following the regulatory changes post-Brexit, the implementation of the Windsor Framework aims to enhance the efficiency of the supply chain and licensing processes for medicines throughout the UK, encompassing Northern Ireland. The framework guarantees that Medicines and Healthcare products Regulatory Agency (MHRA) approval and licensing can be conducted uniformly across the UK and introduces significant modifications concerning the labeling and packaging of medicinal products. Presented below are the key directives that manufacturers and wholesale distributors of medicinal products should familiarize themselves with.
Commencing on 1 January 2025, all medicinal products distributed in the UK are mandated to display a clearly visible 'UK Only' label. This labeling requirement is essential for harmonizing packaging standards across the entire UK market and preventing the entry of these medicines into the EU supply chain. Below are the key points of emphasis:
Nationwide Licensing in the UK: Starting from 1 January 2025, new medicinal products intended for Northern Ireland will be authorized by the MHRA for the entire UK market. These products will not be allowed for sale in the EU, except under specific circumstances, such as 'specials' that adhere to EU regulations.
Labeling Directives: The 'UK Only' label must be prominently featured on the external packaging of the medicine. This label should be in a minimum 7-point font size and must adhere to the current MHRA guidelines and industry best practices. Until 31 December 2024, manufacturers are allowed to continue supplying medicines in legacy EU packaging.
Stickering: Temporary Resolution for Labeling
Manufacturers have the option to affix the 'UK Only' label as a sticker for a limited period, up to 30 June 2025. Post this deadline, the label must be directly printed on the packaging. For those utilizing the stickering method, it should be applied before certification by a Qualified Person (QP) and must not obscure other essential information like batch numbers or expiration dates.
Exemption from the EU Falsified Medicines Directive (FMD)
Effective 1 January 2025, the EU FMD will no longer be applicable to Northern Ireland. Consequently, any features added to packaging solely for FMD compliance can be eliminated or covered. However, UK legislation still mandates the visibility of key details such as batch numbers and expiry dates. While not obligatory, companies can continue incorporating additional safety features like 2D barcodes, provided they meet UK standards.
Continuation of Existing Stock Supply
Any medicinal products introduced to the UK market before 1 January 2025 in their original packaging can be distributed to patients until the expiry date. However, new packages launched after this date must bear the 'UK Only' label.
EU/UK Joint Packaging
Post 1 January 2025, joint EU/UK packaging will no longer be permissible in the UK supply chain. Manufacturers utilizing shared packaging for both the UK and EU markets must ensure the removal of all EU-related information from outer cartons and the addition of the 'UK Only' label. Inner components such as blister packs and leaflets can still be shared, provided that the UK and EU licenses remain in alignment.
Notification Procedure and Deadlines
Companies are obligated to inform the MHRA of any labeling modifications by 31 December 2024. The notification process offers choices for combining the artwork update with other regulatory submissions or selecting self-certification. Companies can also submit a self-certification notification without an updated eCTD sequence by the deadline, but they must complete the sequence submission by 31 December 2025.
Conclusion
The Windsor Framework brings about substantial alterations to the packaging and labeling prerequisites for medicinal products in the UK. As the 1 January 2025 deadline nears, it is imperative for manufacturers and wholesale dealers to confirm to these new standards to ensure seamless market access and compliance. For more comprehensive guidance on the implementation process, please consult the complete MHRA guidelines.
PharmaGXP Services Limited is available to support you in navigating these regulatory changes, ensuring your medicinal products comply with the latest labeling and packaging stipulations. Reach out to us for expert advice on your product’s adherence to the Windsor Framework.
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