Overview of variation applications

Understand the differences between each type of variation application, and which is the correct one for you.

Types of variation applications

There are three types of variation applications for a registered CTGTP:

Major variation (MAV-1) application 

  • Any variation that involves:
    • Change(s) to the approved indication, dosing regimen or patient group(s).
    • Inclusion of clinical information extending the usage of the product e.g. clinical trial information related to an unapproved indication, dosing regimen or patient population.
  • Requires prior approval before the change(s) can be implemented

Minor variation 1 (MIV-1) application

Minor variation 2 (MIV-2) application