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ARGCM Part C, V7.2 February 2018 (archived)
Australian Regulatory Guidelines for Complementary Medicines
The following documents are provided for historical purposes only. Please see Australian regulatory guidelines for complementary medicines for up-to-date guidance.
ARGCM Part C: New complementary medicine substance evaluation
This guidance is for applicants proposing new substances for use as an ingredient in listed medicines. You can submit an application for evaluation for suitability for use in listed medicines for:
- a new complementary medicine substance not currently a permitted ingredient; or
- a proposed new role or a change to a regulatory requirement of use for a permitted ingredient, for example: a proposal for an ingredient permitted for use as an excipient to be used as an active ingredient; or change to the permitted level of use; or change the permitted route of administration.
A request for evaluation of a new complementary medicine substance is considered under Regulation 16GA of the Therapeutic Goods Regulations 1990 (the Regulations). There is an associated fee.
The primary reason for the evaluation of a substance is to determine whether it is of appropriate quality and safety to be permitted for use as an ingredient in listed complementary medicines.
Once permitted for use in listed medicines, an ingredient may be used in a listed medicine by any sponsor.
- Route of evaluation for complementary medicines
- Substances eligible for evaluation for use in listed complementary medicines
- Application phases for a new complementary medicine substance
- Information required for an application for evaluation of a new complementary medicine substance
- Application format
- Administrative information
- General substance information
- Information required to demonstrate the quality of a new complementary medicine substance
- Information required to demonstrate safety of a new complementary medicine substance for use in listed medicines
- Compositional guidelines for complementary medicine substances