Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before those goods can be lawfully imported into, exported from, or supplied in Australia unless otherwise the subject of an exemption, approval or authority under the Therapeutic Goods Act 1989.
However, the CTN and CTA schemes provide for the lawful importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial.
How to determine if your product is unapproved
Our guidance Determine if the product is ‘unapproved’ may be used to help decide whether any of the therapeutic goods (not just the investigational product or main product of interest) used in your clinical trial are considered to be 'unapproved'.
If you are using an 'unapproved' therapeutic good in a clinical trial that is not otherwise subject to an exemption you must notify the TGA through the CTN or CTA schemes.