Leveraging International Dossiers: IRP Pathways for UK MHRA Using US, EU, And Canadian Dossiers

Abstract

The International Recognition Procedure (IRP), introduced by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), provides a streamlined pathway for obtaining marketing authorisation by leveraging approvals from designated trusted regulatory authorities. Replacing earlier reliance mechanisms, the IRP incorporates two review timelines—Recognition A and Recognition B—based on the complexity of the application and the extent of alignment with reference regulator assessments. The procedure can be applied to a wide range of product types and lifecycle stages, including initial authorisations, variations, and renewals. While the IRP facilitates faster patient access to medicines and supports regulatory convergence, it requires careful preparation to meet national requirements, address format and content differences, and ensure complete documentation. This article outlines the scope, eligibility criteria, submission process, and procedural distinctions within the IRP, highlighting its potential benefits for applicants seeking efficient entry into the Great Britain market while maintaining robust standards of quality, safety, and efficacy.