Guidance

Eligibility Checker and submitting your Marketing Authorisation application

Updated 8 April 2024

Guidance on how to complete the Eligibility Checker and submit an International Recognition Procedure for a Marketing Authorisation Application (MAA).   

Overview 

From 1 January 2024 applicants will be able to apply for a marketing authorisation under the International Recognition procedure (IRP).  This will replace the EC Decision Reliance Procedure (ECDRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. 

See further guidance relating to the IRP and whether your application is eligible for this procedure. 

Completing the Eligibility Checker (initial MAAs only) 

The Eligibility Checker should only be completed for Initial MAAs (including line extensions).  

Suitability for Recognition A or B is determined by means of an online Eligibility Checker to be completed by the Applicant 6 weeks before the planned date of MAA submission. 

A product licence (PL) number is required before completion of the Eligibility Checker. If you do not have a 5-digit company number, to allow registration on the MHRA Submissions Portal, this should be requested from Reference.Data@mhra.gov.uk. A PL number can then be obtained through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk. 

Access the Eligibility Checker.

Rules for submitting your completed Eligibility Checker

Before filling in the Eligibility Checker please make sure you have read the guidance on IRP International Recognition Procedure.

You may also find it of benefit to review the full list of questions, which includes some guidance, before completing the form.

The form will ask a series of questions that enables the MHRA to identify the appropriate IRP Route A or B.  In a small number of cases, it will require triage by the MHRA to reach a conclusion on this route. Some points worth noting: 

• To be eligible for Recognition A, the RR approval must have been granted within the previous 2 years. 
• To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years.  
• If your application is older than 10 years you may still be eligible, but you will need to check with the MHRA before filling in the Eligibility Checker.  

Submitting your completed Eligibility Checker form. 

Once you have completed the form and downloaded it, follow the submission instructions at the top of the form.    

The following table indicates how to submit this form:

The completed form indicates you are suitable for Recognition A or B	Submit the form along with your MAA application.
The completed form indicates that it requires triage by the MHRA	Submit the form directly to Recognition@mhra.gov.uk at least 6 weeks before the intended date of MAA submission. On receipt of the eligibility form by email, the MHRA will conduct a triage and inform you of the outcome or request further information.
Your product is a New Active Substance and the completed form indicates it is Recognition A or B	You are required to notify the MHRA of your intention to submit a NAS. To do this, submit the form directly to Recognition@mhra.gov.uk at least 6 weeks before the intended date of MAA submission. You should not expect to be contacted by the MHRA prior to submission. Submit the form along with your MAA application.
Your product is a New Active Substance, and the completed form indicates that it requires triage by the MHRA	Submit the form directly to Recognition@mhra.gov.uk at least 6 weeks before the intended date MAA submission. On receipt of the eligibility form by email, the MHRA will conduct a triage and inform you of the outcome or request further information.

Submitting your MA application 

You should submit your MA 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 whether your application is: 

Initial Marketing Authorisation NAS – IR Route A 

Initial Marketing Authorisation NAS – IR Route B 

Initial Marketing Authorisation – IR Route A 

Initial Marketing Authorisation – IR Route B 

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 to questions 

You can find out more in our guidance about the MHRA submission portal.  

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. 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 Initial applications variations and renewals. 

Further information is included in Apply for a licence to market a medicine in the UK.

Fees 

Fees for submission for international recognition applications are included on MHRA fees.