Applications for new medicines via the MHRA’s forthcoming International Recognition procedure (IRP) move a step closer today, with the launch of the Agency’s new online ‘Eligibility Checker’ tool.
From today (Monday 20 November), applicants should use this new tool to determine whether their Marketing Authorisation Application (MAA) is suitable for IRP and to identify which route (A or B) to follow, before submitting an IRP application. The new IRP itself becomes operational in six weeks’ time, on 1 January 2024.
The IRP is a further initiative to help bring life-saving medicines to UK patients that has been developed by the MHRA following the UK’s departure from the European Union. It allows the Agency to take into account the expertise of trusted regulatory partners in other countries when authorising medicines. As a sovereign regulator, the MHRA retains ultimate authority to accept or reject such medicines, when determining applications submitted via IRP.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
“Our new online Eligibility Checker tool has been tailored to facilitate a smooth and efficient process for marketing authorisation applicants.
“From today, we encourage applicants to begin to use the tool in readiness for making submissions via the International Recognition Procedure from 1 January 2024.
“Once IRP is fully up-and-running in January, we will have created a further route for bringing new medicines to UK patients.”
Follow us on Twitter: @MHRAgovuk
Follow us on LinkedIn: Medicines and Healthcare products Regulatory Agency
- Access the new online Eligibility Checker tool here:
- £10m in funding from HM Treasury was announced earlier this year to support the development of this new recognition framework.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the [email protected].