Decision trees

Use this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.

Use this decision tool to help you determine if your product is a medical device.

Use this decision tree to help you determine if your sports supplement is declared to be a therapeutic good.

Sponsors of listed medicines (AUST L), use this decision tool to understand what is required to have your listed medicine in the Australian Register of Therapeutic Goods (ARTG).

Use this decision tree to help you understand if you can advertise a particular therapeutic good to the public.

Health practitioners, use this guide to determine which pathway, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme, is appropriate to use.

Use this decision tree to work out the classification of the medical device you want to sell or supply in Australia.

Use this decision tree to determine whether Unique Device Identification (UDI) requirements apply to the devices you supply in Australia.

Use this decision tree to determine when Unique Device Identification (UDI) requirements are mandatory for the devices you supply in Australia.

Sponsors of medicines, use this decision tool to determine the patient impact level of a shortage (or an anticipated shortage) of products and if you need to report it.

Use this decision tree to assist you to determine if GMP licencing or certification is required.

Use the GMP Clearance Application Assistance Tool (CAAT) to assist in determining the general evidence requirements for your GMP clearance applications.

Use this tool to determine if your product is a food or medicine.