International Recognition Procedure Flashcards
Tell me about the IRP
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.
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 will allow the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.
The MHRA will conduct a targeted assessment of IRP applications but retain the authority to reject applications if the evidence provided is considered insufficiently robust.
Traditional Herbal Registrations, Homoeopathic Registrations (Simplified Registration Scheme) and Homeopathic National Rules Authorisations (National Rules Scheme) are excluded from IRP.
IRP can also be used for post-authorisation procedures including line extensions, variations and renewals (see Product lifecycle).
The RR assessment must have undergone a full and standalone review. RR assessments based on reliance or recognition cannot be used to support an IRP application.
Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval) can support an IRP application. Emergency approvals are not eligible.
Until the Windsor Framework is implemented in Northern Ireland on 1 January 2025, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain.
There are two recognition routes for initial MAAs
What are the key features of the IRP recognition route A
To be eligible for Recognition A, the RR approval must have been granted within the previous 2 years.
A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP.
The manufacturing process must be the same as that approved by the RR, with evidence of compliance with Good Manufacturing Practice (GMP) at the time of IRP submission.
The Recognition A route will be open to applications that meet the criteria for IRP and do not meet any of the Recognition B criteria.
Recognition A procedures will run to 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.
Tell me about the key features of the IPR Recognition Route B
To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years.
A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP.
Recognition B procedures will run to a 110-day timetable from validation to allow for consultation with the Commission on Human Medicines (CHM).
Recognition B includes one clock stop at day 70, allowing the Applicant up to 60 days to respond to any issues identified.
If there are outstanding Major Objections at Day 110, formal advice on approvability will be sought from CHM, and the timetable will revert to the national 210-day timetable.
IRP can be used for line extensions, variations (Type 1B, Type II) and renewal applications (including annual renewal of conditional MAs and annual reassessment of exceptional circumstance MAs).
Tell me about the IRP submissions process
You should submit your application through the Human Medicines Portal.
No other submission route is acceptable for IRP.
You will be asked when submitting to indicate if your application is Recognition Route A or Route B or if you are submitting a Recognition variation.
As per the current functionality, you will need to indicate if your submission is one of the following:
* Original submission
* Validation Correction Request (VCR)
* Response
An IRP application should be submitted to the MHRA as one electronic Common Technical Document (eCTD) sequence through the MHRA Submissions portal.
The eCTD should be in EU format with a UK-specific module 1.
You must include certain information in the cover letter.
The eCTD submission should be aligned with the consolidated dossier as reviewed by the RR, including the full responses of the Applicant to RR questions.
Approved post-authorisation changes including variations should be included with the MHRA MAA submission once approved by the RR. For initial MAAs, the IRP submission should include:
* documentation of the RR’s approval decision.
* all iterations of the RR’s assessment reports for the initial authorisation and any major post-authorisation procedures (e.g., significant variations, renewals).
* the final product information (or international equivalent) approved by the RR.
For post-authorisation IRP applications (including variations), the submission should include:
* documentation of the RR’s approval decision.
* all iterations of the RR’s assessment reports for the relevant post-authorisation procedure.
* the final product information (or international equivalent) approved by the RR if applicable.
What countries have signed up to the IRP to date?
Australia,
Japan,
Switzerland,
USA,
EU,
Singapore,
Canada
