Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
About this guideline
Adopted by the TGA: 28 February 2020
End of consultation (overseas): 30 November 2016
Categories: Quality
TGA annotations
Applicants must be able to demonstrate an established tradition of use for traditional use indications in Australia. Please refer to the Australian Regulatory Guidelines for Complementary Medicines, which identify traditional use as generally equating to three generations of human use.
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
- All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.
For more information see International scientific guidelines adopted in Australia.