UK: MHRA Introduces Eligibility Checker for MAAs via IRP (20 November 2023)

ARQon
Nov 22, 2023
1 min read

As we are approaching 1 January 2024 in 6 weeks’ time, that means the EC Decision Reliance Procedure (ECDRP) will be replaced by the International Recognition Procedure (IRP). So, all applications for new medicines will be authorized under the IRP.

An online tool, “Eligibility Checker” has been developed to smoothen the procedure of bringing life-saving medicines to UK patients via the International Recognition Procedure (IRP). Starting from 20 November 2023, all involved applicants are advised to utilize the tool in order to ensure the eligibility of their Marketing Authorization Applications (MAAs) for the IRP and determine the suitability of routes offered (Route A or Route B).

Completing the Eligibility Checker (initial MAAs only)

Applicants have to obtain the 5-digit company number and the product license (PL) number before completing the Eligibility Checker. The PL number can be requested from PLNumberAllocation@mhra.gov.uk while the 5-digit company number should be obtained from Reference.data@mhra.gov.uk. The route recognition suitability will be determined once the Eligibility Checker is completed 6 weeks before the MAA submission planned date.

Requirements for Submitting a Completed Eligibility Checker

Applicants are required to read the IRP guidance and answer the series of questions in order to assist MHRA in classifying the appropriate IRP route for submission. Triage might be required in some cases. Applicants should take note of the information below:

Recognition A eligibility criteria: RR approval must be granted within the previous 2 years
Recognition B eligibility criteria: RR approval must be granted within the previous 10 years

Submission Procedure for Completed Eligibility Checker Form