Snapshot

The International Recognition Procedure - Recognition A pathway has been developed by the of United Kingdom.

This pathway can be used where From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices. For ECDRP applications, the Committee for Medicinal Products for Human Use (CHMP) positive opinion (but not necessarily the European Commission Decision) should be received before 31 December 2023. IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs). A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP. The same product is defined as having the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, from Applicants belonging to the same company or group of companies or which are ‘licensees’. IRP can also be used for post-authorisation procedures including line extensions, variations and renewals..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Japan Singapore Switzerland United States

For initial MAAs, Recognition A is a 60-day timetable from validation, with no clock stop. However, if Major Objections are identified which cannot be resolved within 60 days, the timetable may revert to Recognition B. 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 eligibility form to be completed by the Applicant 6 weeks before the planned date of MAA submission. Applications that are determined not eligible for Recognition A or B can be submitted as full national applications if MHRA requirements are met.