Clearance Application Assistance Tool
All steps of manufacture are required to be GMP compliant unless they are exempt. However, GMP clearance is not necessarily required unless the product is to be registered or listed and the manufacturing step recorded on the Australian Register of Therapeutic Goods (ARTG).
If you are unsure whether GMP clearance is required, for the purpose of registering or listing your product on the ARTG, contact the relevant product regulatory area prior to submitting a GMP clearance application.
The GMP Clearance Application Assistance Tool (CAAT) provides assistance in determining the general evidence requirements for your GMP clearance applications.