Understanding the UK’s International Recognition Procedure

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Since the United Kingdom’s (UK) exit from the European Union (EU) in 2020, numerous changes have been implemented in the procedures to ensure that UK patients have access to medicines.

One area of interest and a growing topic of discussion in the pharmaceutical industry is the International Recognition Procedure (IRP), which was introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) on January 1, 2024, replacing and expanding on the European Commission Decision Reliance Procedure (ECDRP) (1).

The introduction of the IRP has brought opportunities for faster market access for manufacturers by enabling the MHRA to conduct more targeted assessments by taking into account the expertise and decision-making of trusted regulatory partners.

The IRP also allows the MHRA to perform product lifecycle activities utilized for post-approval submissions, including line extensions, variations (Type IB and Type II) and renewals for a medicinal product with an existing marketing authorization (MA) provided by one of MHRA’s acceptable regulatory reference (RR) which include:

The IRP may also be used for Access Consortium approvals that did not include MHRA as part of the work-sharing procedure (1).

International Recognition Procedure Process

New IRP marketing authorization application

A new MA may be achieved via one of two possible recognition pathways:

• Recognition A — Is applicable if the reference regulator MA has been granted within the previous 2 years (60-day procedure, no clock stops).
• Recognition B — Is applicable if the reference regulator MA has been granted within the previous 10 years and fulfills at least 1 of the 24 listed criteria (110-day procedure with no more than 1 clock stop. If there are outstanding major objections at day 110, formal advice on approvability will be sought from the Commission on Human Medicines, and the timetable will revert to the national 210-day timetable (1).

Post-authorization IRP applications: variations and renewals

The IRP can be used during the lifecycle of products that have been initially authorized or subsequently varied via standalone national, Mutual Recognition and Decentralized Reliance Procedure or European Commission Decision Reliance Procedure routes. Conversely, where a product has been authorized via IRP, it is acceptable to submit standalone national post-authorization procedures including variations (1).

Full details of the IRP submission process and requirements are provided on the MHRA website:

• International Recognition Procedure
• eCTD guidance for marketing authorisation and post-authorisation applications

Who Can Apply?

To ensure that the applicant/marketing authorization holder (MAH) can fulfill the submission requirements as well as all their legal obligations as the holder of an MA, such as the obligations stated in regulations 74 and 75 of the Human Medicines Regulations 2012, the applicant/MAH must be established in the UK (Great Britain or Northern Ireland) or the EU/European Economic Area. It is anticipated that the applicant for an IRP application is the same company or belongs to the same (legal) group of companies as the MAH of the RR procedure (1).

In some situations, it may be possible to accept applications from third parties if the applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA (1).

Key Advantages of Using the IRP?

Expansion of international collaborations

The IRP allows the MHRA to consider the decisions of trusted regulatory partners both from the EU and globally, expanding international collaborations and reducing the repetition of work for the health authorities and MAHs alike (1).

Fast market access

Navigating the regulatory processes in the lead-up to the submission can be challenging. Submitting a marketing application is a significant undertaking involving multiple stakeholders over a period of up to 2 years (if all goes to plan).

Expedited approval with review times of 60 days (Route A) and 110 days (Route B) are significantly shorter than the MHRA national route for marketing authorization application (MAA), which has a 210-day timetable. This will allow quicker market access for medicines authorized outside of the EU and reduce assessment pressure and time burden on the MHRA (2).

MHRA Support

For MAAs, the MHRA requires an online eligibility form to determine suitability for recognition pathway A or B. Applicants intending to submit via the IRP have the option of requesting pre-submission advice through a form and returning it to presubmission@mhra.gov.uk (3).

The IRP has been operational since January 1, 2024. In January 2025, a total of 453 IRP submissions (Type IB-273 and Type II-180) were approved, with 95-97% granted within the statutory timeframe (4).

MHRA Metrics for January 2025

Other Considerations

Eligibility constraints

IRP is only applicable to:

• Chemical and biological new active substances and known active substances
• Generic applications
• Hybrid applications
• Biosimilar applications
• New fixed combination product applications

It is not applicable to:

• Bibliographic applications
• Traditional herbal registrations
• Homoeopathic registrations

Best Use of IRP

What is your understanding of the IRP, and have you used it for marketing applications? We are interested in hearing about your experiences around this topic and are happy to offer guidance on managing IRP submissions in the UK.

For more in-depth information and valuable insights into IRP and how it affects MAs in the UK, please watch our recent webinar titled “Navigating the UK International Recognition Procedure.”

References

1. International Recognition Procedure - GOV.UK Updated 29 Jan 2024
2. The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization - Voisin Consulting 6 February 2024
3. https://www.gov.uk/guidance/pre-submission-advice-support 13 August 2024
4. PowerPoint Presentation January 2025