November 12, 2024
The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for pharmaceutical development and licensing in the United Kingdom (UK). This framework aims to streamline the licensing process, ensuring that medicines are authorized across the entire UK, including Northern Ireland, under a unified system managed by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Windsor Framework is a post-Brexit legal agreement between the European Union (EU) and the UK. The agreement was announced on 27 February 2023 and formally adopted on 24 March 2023. This framework was designed to address the complexities and political concerns surrounding the Northern Ireland Protocol by easing customs checks on goods moving from Great Britain (GB) to NI and ensuring NI’s place within the UK internal market.
Under the Windsor Framework, the MHRA will license all medicines for human use across the UK. This change eliminates the previous complexities where Northern Ireland followed EU regulations while the rest of the UK adhered to separate guidelines. Now, a single UK-wide marketing authorization (MA) will be issued, simplifying the process for pharmaceutical companies.
Pharmacovigilance, the practice of monitoring the effects of medical drugs after they have been licensed for use, will also see significant changes. The new framework mandates that all medicines approved in the UK adhere to the Human Medicines Regulation 2012 (as amended). This ensures a consistent approach to safety monitoring and reporting across the UK.
The Windsor Framework introduces new requirements for labelling and packaging to ensure clarity and uniformity. This is particularly important for products that will be distributed across different regions within the UK, ensuring that all necessary information is accessible and understandable to healthcare professionals and patients alike.
Under the Windsor Framework, all Parallel Import Licences (PLPIs) will now be authorised across the entire UK, replacing previous GB-only restrictions. Products must display a "UK Only" label. These products will only be able to be sold in the UK and will not be available on the market in Ireland or anywhere else in the EU. However, one exception to the rule is that they will be available in the EU as ‘specials’ subject to EU rules and conditions. They must also adhere to updated packaging, labelling, and safety standards. Additionally, the Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. Existing stock can continue to be sold, but all new packaging will need to comply with these updated requirements.
The Windsor Framework is poised to bring several benefits to pharmaceutical developers:
Starting on January 1, 2025, companies will no longer be allowed to hold a product license in both Great Britain (PLGB) and Northern Ireland (PLNI) for the same product. To retain your PLGB (which will be valid across the UK beginning January 1), please ensure you:
Failure to comply may result in the MHRA cancelling the PLGB on January 1, 2025. If you have not already informed the MHRA of your request to cancel your PLNI, you must do so immediately – ProPharma can support these notifications!
The Windsor Framework represents an industry-changing step for pharmaceutical development and licensing in the UK. By simplifying regulatory processes and enhancing market access, it offers significant opportunities for pharmaceutical developers. With ProPharma’s unparalleled expertise, you can confidently navigate this new landscape and bring your products to market efficiently and effectively.
Navigating these regulatory changes can be complex, but ProPharma is here to help. With extensive expertise in regulatory strategy, interactions, and consulting, ProPharma is uniquely positioned to support pharmaceutical companies through this transition.
Our team of expert regulatory affairs consultants can support with the following:
Interested in learning more? Contact us today to find out how ProPharma’s team of expert regulatory consultants can help you achieve regulatory success across the UK and Europe, including compliance with The Windsor Framework.
References
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