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Health Sciences Authority

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.

Last updated 19 March 2026

Overview of variation application types

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

Overview of MAV-1 application

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

Minor variation (MIV) application

Understand how to submit a minor variation (MIV) application for your registered therapeutic product

Reclassification of therapeutic products

Find out how to change the forensic classification of your therapeutic products, and check for the latest updates on medicines that we have reclassified.