Post-approval variation application of registered therapeutic drugs

Submit a variation application to us when there is a change to your registered therapeutic product's safety, efficacy, quality or forensic classification.

Overview of variation application types Understand the differences between each type of variation application, and which is the correct one for you. Major variation (MAV-1) application Follow this guide to change the approved indication, dosing regimen, patient group, or clinical information to extend the usage of your registered product. Major variation (MAV-2) application Find out how to change the forensic classification of your therapeutic products, and check for the latest updates on medicines that we have reclassified. Minor variation (MIV) application Understand how to submit a minor variation (MIV) application for your registered therapeutic product. Minor variation (MIV) self-guided tool

Find out about the submission requirements specific for your MIV applications.

Last updated: 31 Dec 2018

Post-approval variation application of registered therapeutic drugs

Therapeutic products

Therapeutic products