BRIEF—MHRA launches online Eligibility Checker tool for applications via the new IRP

The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) announced that the forthcoming  International Recognition procedure (IRP) moved a step closer today, with the launch of the Agency’s new online ‘Eligibility Checker’ tool.

From November 20, applicants should use this new tool to determine whether their marketing authorization 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 January 1, 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 authorizing medicines. As a sovereign regulator, the MHRA retains ultimate authority to accept or reject such medicines, when determining applications submitted via IRP.