Fusion Pharma has reviewed the recent collaboration between NHS England (NHSE), the Medicines and Healthcare products Regulatory Agency (MHRA), and Medicines UK. This joint initiative aims to provide Marketing Authorisation Holders (MAHs) with the opportunity to re-evaluate inactive or “dormant” licences through the newly launched Project Revive: Rapid Reactivation Programme for Dormant Medicines Licences.
What is Project Revive and who should take part?
Project Revive is designed to enable MAHs to reassess their dormant licences, offering a regulatory pathway towards their rapid reactivation.
The programme is specifically targeted at MAHs, holding inactive licences on the priority list (Top 40, Single Supplier, No Offers), encouraging them to consider the potential benefits of re-marketing these products to prevent shortages and ensure timely availability to patients.
NHS England, Medicines UK, and the MHRA are collaborating to ensure seamless operational implementation of Project Revive and each organisation plays a crucial role in supporting the regulatory pathway and fostering industry engagement: Medicines UK will provide programme management, the MHRA will offer direct supplier support e.g. priority regulatory meetings, whereas the NHSE Medicines Procurement & Supply Chain (MPSC) has identified the priority products in the programme.
Aiming to mitigate supply vulnerabilities and supplier risks
The programme has been established to tackle vulnerabilities in the supply of medicines, with particular attention given to the risks associated with reliance on single suppliers. It seeks to proactively manage and reduce the impact of potential disruptions, ensuring a more resilient supply chain.
Furthermore, the initiative considers the challenges faced by suppliers, such as maintaining sustainable market levels and ensuring that pricing remains commercially viable. By addressing these factors, the programme aims to create an environment where suppliers can operate effectively, reducing the likelihood of supply interruptions.
What are the next steps for MAHs?
The outlined plans involve engaging suppliers through multiple channels to facilitate commercial viability assessments, regulatory alignment, and integration with internal procurement planning procedures. One of the next steps involves developing a process that includes key milestones, ensuring completion within a maximum 12-month end-to-end timeline.
The product list was made available by Medicines UK in January 2026, and companies are now invited to declare expression of interest in potential participation by end of March/April 2026.
MAHs, interested in the programme, are required to start conducting an internal review and due diligence to confirm ability to manufacture and supply of the selected products. This will also include regulatory assessment to determine potential changes/variations required to reactivate or bring the licences up to date.
If you would like to discuss how Fusion Pharma can support you with reactivating your licences and how to best benefit from this project, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
