The MHRA has announced several updates to the International Recognition Procedure (IRP) that will come into effect on 1 September 2026. Companies planning UK submissions should review these changes carefully, particularly those relying on Route B.
Here are the key updates:
- Validation process: Applicants will have only one opportunity to respond to a Validation Correction Request (VCR), aligning the IRP with the national procedure.
- New active substances: Applicants must notify the MHRA of their intended submission at least 8 weeks in advance to support resource planning.
Route B – Major change: The acceptable reference regulatory approval window will be reduced from 10 years to 5 years. This is a significant update that could affect regulatory strategies for products relying on older reference approvals. Route A remains unchanged at 2 years.
New contact tools: The MHRA has introduced two new forms to support applicants:
• IRP Pre-Submission Advice Form
• IRP Contact Form
These updates are intended to improve predictability, streamline the review process, and ensure the IRP continues to make efficient use of decisions from trusted regulatory partners.
How can Asphalion help? Our Regulatory Affairs experts can assess the impact of these changes on your portfolio, help you determine the most appropriate regulatory pathway, and support you in preparing a robust UK submission strategy. Contact us at: [email protected]
You can read the full MHRA announcement and updated guidance here: https://bit.ly/4vZ4I3O
