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UK MHRA: Guidance on International Recognition Procedure

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure" that streamlines the approval process for medicines, making it easier for manufacturers to gain access to international markets.

With effect from 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the International Recognition Procedure (IRP) and the Mutual Recognition/Decentralized Reliance Procedure (MRDCRP) will be incorporated into the IRP.

IRP can be used for the following types of marketing authorisation applications (MAAs) according to the Human Medicines Regulations 2012 (HMRs):

  • Regulation 50: chemical and biological new active substances and known active substances.

  • Regulation 51, 51A and 51B: generic applications

  • Regulation 52, 52A and 52B: hybrid applications

  • Regulation 53, 53A and 53B: biosimilar applications

  • Regulation 55: new fixed combination product applications

The IRP is accessible to applicants who have previously obtained authorization for an identical product from one of MHRA's designated Reference Regulators (RRs). IRP can also be utilized for post-authorization processes such as line extensions, variations, and renewals. Conditional and Exceptional Marketing Authorizations (MAs), or their international equivalents like provisional or accelerated approvals, are acceptable for supporting an IRP application.

There are two recognition timetables for initial MAAs:

  • Recognition A: 60-day timetable

  • Recognition B: 110-day timetable

The timetables are calendar days and start once the IRP submission has been validated by MHRA. Suitability for Recognition A or B is determined by means of an online eligibility form to be completed by the Applicant 6 weeks before the planned date of MAA submission.

To know more exclusively about the documents that comprise a complete assessment for each RR and the full set of documents that must be submitted in your application, click this LINK.


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