Class 2 CTGTP Registration

Registration process for Class 2 CTGTP

Find out how to register your Class 2 CTGTP and retain, cancel or transfer a product registration here.

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.

Special Access Routes (SAR)

In specific situations, we may allow the import or supply of Class 2 CTGTP via Special Access Routes (SAR).

Summary of Benefit-Risk Assessment Reports

The reports contain a summary of the quality, safety and efficacy of approved Class 2 CTGTPs, and HSA's benefit-risk assessment for the approvals.