International Recognition Procedure (IRP)

The International Recognition Procedure (IRP) has featured in every one of our newsletters since Fusion Connect went live in 2023 – with IRP being in place since 1st Jan 2024, we felt this newsletter should be no exception!

For those wondering why we are still ‘banging on’ about it, the IRP is the final installment of the post-Brexit procedures (hopefully) and having been in place for near 4 months, it is a good point to review our experience so far.

The IRP not only allows the UK to continue to recognise assessments carried out by the EMA / EU, but has enhanced the offering further by adding 6 new ‘Reference Regulators’ from around the world.

As a reminder, the IRP is open to applicants that have received an authorisation for the same product from one of the Reference Regulators (RR) within the last 10 years. The first step is to consider if your proposed medicine is eligible for IRP, if so, the online ‘Eligibility Checker’ should be completed to determine which route, A or B, is required – or if you need to submit a national application instead. The MHRA have published guidance on the requirements and supporting documentation for both marketing authorisation applications (MAAs) and life cycle management (LCM) submissions.

Don’t forget the Windsor Framework when planning your submissions – adding ‘UK Only’ to all new MAAs or updating artwork within LCM submissions ready to be implemented for the first batch release after 1st Jan 2025. If you need further understanding of the measures due to be implemented and your obligations, take a look at our recent webinar here.

If you are sticking with recognising the EU – either through IRP or MRDC, then very little has changed. However if you are looking to take advantage of this new route to market using one of the new Reference Regulators, then IRP absolutely opens up opportunities to grow your business and reach new patients in the UK. Please do make sure however that you are ready to use IRP in both the short and long term, and don’t just rush in without considering how this is ‘future-proofed’.

In terms of experience so far, the MHRA are approving LCM submissions much quicker than national timelines, and the first Marketing Authorisation was granted on 4th April within 55 days – so, so far, so good!

Fusion Pharma recently presented a live webinar on the topic which delves into a lot more detail on the process and lists key guidance and resources available, which you can view here. Reach out to us to request a copy of the presentation and a full list of Q+A from the webinar.

As always, we are here to answers any questions you may have – please reach out.

By Leah Heathman