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