Variation applications for registered Class 2 CTGTP
Submit a variation application to us when there is a change to your registered CTGTP's safety, efficacy or quality information.
Last updated 25 March 2026
Major variation-1 (MAV-1) applications
Understand the requirements to change the clinical usage of your registered Class 2 CTGTP including the indication, dosage regimen or patient group.
Minor variation (MIV-1 or MIV-2) applications
Understand the requirements of MIV applications for changes to your registered Class 2 CTGTP.