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Guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations

We have adopted this International Scientific Guideline - EMEA/HMPC/166326/05.

Last updated

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: 1 July 2006

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.

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