MHRA launches online Eligibility Checker tool for applications via the new聽 International Recognition Procedure (IRP)
IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024
Applications for new medicines via the MHRA鈥檚 forthcoming International Recognition procedure (IRP) move a step closer today, with the launch of the Agency鈥檚 new online 鈥楨ligibility Checker鈥� 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. 皇冠体育app new IRP itself becomes operational in six weeks鈥� time, on 1 January 2024.
皇冠体育app IRP is a further initiative to help bring life-saving medicines to UK patients that has been developed by the MHRA following the UK鈥檚 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:
鈥淥ur new online Eligibility Checker tool has been tailored to facilitate a smooth and efficient process for marketing authorisation applicants.
鈥淔rom today, we encourage applicants to begin to use the tool in readiness for making submissions via the International Recognition Procedure from 1 January 2024.
鈥淥nce IRP is fully up-and-running in January, we will have created a further route for bringing new medicines to UK patients.鈥�
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- Access the new online Eligibility Checker tool here:
- 拢10m in funding from HM Treasury was announced earlier this year to support the development of this new recognition framework.
- 皇冠体育app 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.聽 All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- 皇冠体育app MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the聽[email protected].