“Our new online Eligibility Checker tool has been tailored to facilitate a smooth and efficient process for marketing authorisation applicants. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: As a sovereign regulator, the MHRA retains ultimate authority to accept or reject such medicines, when determining applications submitted via IRP. It allows the Agency to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.
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. The new IRP itself becomes operational in six weeks’ time, on 1 January 2024. 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.įrom 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.
