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.
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.”
- 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.
