📢Updated guidance for the International Recognition Procedure (IRP) is now available.
As part of the MHRA commitment to continuously improving our regulatory processes, we’ve updated the IRP guidance to reflect several changes that will come into effect from 1 September 2026.
The updates are informed by our experience since the IRP launched in 2024 and are designed to support greater consistency, predictability and efficient planning for applicants.
🚩Key changes include:
• A single opportunity to respond to a Validation Correction Request, aligning the IRP with the national procedure.
• An eight-week notification period for intended submissions of new active substances.
• A revised reference approval window for Route B applications, reducing from 10 years to 5 years.
• New guidance on switching to an extended timetable where major objections remain outstanding.
• A new “Contact Us” section, including an IRP query template and pre-submission meeting request form.
⏱️There remains a window to submit applications under the current process until 11:59pm on 31 August 2026.
Read the updated guidance and find out more: https://brnw.ch/21x47Mq