A New Era for Pharmaceutical Development and Licensing in the UK
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).
Background
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.
Key Developments and Implementation Plans for UK’s Windsor Framework
1. UK-Wide Licensing
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.
2. Pharmacovigilance Adjustments
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.
3. Labelling and Packaging
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.
4. UK Parallel Import Licences Following Agreement of the Windsor Framework
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.
Impact on Pharmaceutical Developers
The Windsor Framework is poised to bring several benefits to pharmaceutical developers:
- Simplified Regulatory Processes: By unifying the licensing system, developers can navigate a single regulatory pathway, reducing administrative burdens and accelerating time-to-market for new medicines.
- Enhanced Market Access: With a UK-wide Marketing Authorisation process, companies can more easily distribute their products across the entire UK, including Northern Ireland, without the need for separate authorizations.
- Improved Pharmacovigilance: Consistent safety monitoring and reporting requirements will help maintain high standards of patient safety and product efficacy.
Immediate Action Required
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:
- Notify the Reference Member State (RMS) of your intention to withdraw Northen Ireland as a Concerned Member State (CMS) from the Decentralised Procedure (DCP)/Mutual Recognition Procedure (MRP)
- Submit a request to MHRA by September 30, 2024, to cancel the PLNI (effective December 31, 2024)
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!
Transforming Product Development & Licensing in the UK
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.
ProPharma: Your Partner in Regulatory Excellence
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:
- Regulatory Strategy: ProPharma’s team of experts can help you develop a robust regulatory strategy that aligns with the new requirements of the Windsor Framework. From initial planning to execution, we ensure that your products meet all necessary standards for UK-wide approval.
- Regulatory Interactions: Effective communication with regulatory bodies is crucial. ProPharma facilitates seamless interactions with the MHRA, ensuring that your submissions are clear, comprehensive, and compliant with the latest guidelines.
- Regulatory Consulting: Our comprehensive regulatory consulting services cover everything from dossier preparation to post-approval maintenance. We manage the entire lifecycle of your product, ensuring ongoing compliance and addressing any regulatory challenges that arise.
References
https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines/uk-wide-licensing-for-human-medicines
https://www.gov.uk/government/publications/pharmacovigilance-following-agreement-of-the-windsor-framework/pharmacovigilance-following-agreement-of-the-windsor-framework
