Definition: Evidence that shows that the medicine or the relevant ingredients in the medicine have a significant history of use in the specified tradition for the specified therapeutic purpose. You are required to hold documentary evidence that your medicine or its active ingredient has been used for at least three generations (at least 75 years) in the tradition it belongs to. This will establish that it belongs to that tradition and that there is an accumulated repository of observations in humans that underpins the use of the medicine.
As per: TGA