International Recognition Procedure for Product Lifecycle
Updated 8 April 2024
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This publication is available at https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure-for-product-lifecycle
Applying for Variations and Renewals under International Recognition Procedure (IRP)
See further guidance relating to IRP variations and renewals and whether your application is eligible for this procedure.
Submitting your IRP Variation or Renewal
You should submit your application through the Human Medicines Portal under MHRA Submission Platform/Hub. No other submission route is acceptable for IRP. You will be asked when submitting to indicate your Application Type. Please choose the appropriate option for your Submission:
Variation Type IB - International Recognition
Variation Type II - International Recognition (New Indication)
Variation Type II - International Recognition (Excluding New Indication)
Renewal (yearly or 5 yearly) – International Recognition
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
You can find out more in our guidance about the MHRA submission portal.
Information on how to register to use this portal is given at Register to make submissions to the MHRA.
An IRP variation or renewal application should be submitted to the MHRA as one consolidated sequence of the required information approved by RR at the submission date through the MHRA Submissions portal. The eCTD should be in EU format. You must include certain information in the cover letter and follow the instruction given in the eCTD Guidance for IRP.
The eCTD guidance gives instructions on where to include the relevant data required to submit for both variations and renewals.
Fees
Fees for submission for international recognition applications are included on MHRA fees.