Overview of MAV-1 application

Understand the process and requirements to submit a MAV-1 application.

MAV-1 overview

A MAV-1 variation application applies to changes in a registered therapeutic product in any of the following areas:

  • Approved indication.
  • Dosing regimen.
  • Patient group.
  • Inclusion of clinical information extending the usage of the product.

You can submit up to a maximum of three MAV-1 applications for each product registration at any one time.

There are three evaluation routes for a MAV-1 application, with different eligibility criteria and documentary requirements:

Evaluation route Eligibility
Full A major variation that has not been approved by any drug regulatory agency at the time of submission.
Abridged A major variation that has been evaluated and approved by at least one drug regulatory agency.
Verification
  • A major variation that has been evaluated and approved by at least two of our reference drug regulatory agencies.
  • The MAV-1 must be submitted within three years from the date of approval by the chosen primary reference agency.
  • The product has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.
  • Consult us on the eligibility for the verification route prior to submission if:
    • Your product's proposed indication has been designated as an Orphan Drug by at least one reference drug regulatory agency.
    • Your product has been approved by at least one reference drug regulatory agency via an accelerated or fast track approval, approval under exceptional circumstances, or an equivalent approval process.
Note: The product does not need a more stringent assessment due to differences in local disease patterns or medical practices.

MAV-1 fees and turnaround time

You may wish to consider which evaluation route to choose based on the fees and turnaround times, in the event that your product qualifies for more than one evaluation route.

Refer to therapeutic product fees and turnaround time for more information.

Evaluation stages

The evaluation stage begins after the application is accepted after screening. For applications submitted via the full or abridged evaluation routes, their evaluation will proceed through the four evaluation stages below. You may view the evaluation stage of your application at track@prism.

Evaluation stages Description
Stage 1: Acceptance for evaluation Application is accepted for evaluation. This marks the start of the evaluation timeline.
Stage 2: Active evaluation in progress When active evaluation is in progress for the application.
Stage 3: Evaluation at midway Application is approximately midway through the evaluation. Applicants can expect to receive the first set of queries from us during this stage.
Stage 4: Completed evaluation Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision letter will be issued.

Progressive Payment Scheme

Applications under the GIRO payment scheme may opt-in for the Progressive Payment Scheme when they submit a MAV-1 via the full or abridged evaluation routes.

This option must be decided at the point of the application submission and cannot be changed once the application has been submitted. If you wish to change your selected payment scheme, you will have to withdraw and re-submit the application. All payments made, such as the screening fee, are non-refundable.

The Progressive Payment Scheme is not applicable for MAV-1 applications submitted via the verification route.

The table below shows the percentages of payments applicable for each stage of the evaluation under the progressive payment scheme.

Evaluation stages Progressive payment scheme percentage
Stage 1: Acceptance for evaluation 30%
Stage 2: Active evaluation in progress 40%
Stage 3: Evaluation at midway 20%
Stage 4: Completed evaluation 10%

If an application under the progressive payment scheme is withdrawn during the evaluation stage, any fees that were charged, but not debited from the GIRO account, would remain payable. All payments made are non-refundable.

Submit your MAV-1 application

Once you have decided on an evaluation route for your MAV-1 application, you may proceed to our registration guide for the steps and documents required to complete your registration.

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