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Route of evaluation for complementary medicines
ARGCM Part C: New complementary medicine substance evaluation
Schedule 10 of the Regulations prescribes which office within the TGA conducts the evaluation of specific therapeutic goods.
Part 2 of Schedule 10 states that a complementary medicine (including substances) that do not meet the criteria for mention in Schedule 4, 8 and 9 of the Poisons Standard are evaluated by the Office of Complementary Medicines (now named Complementary and OTC Medicines Branch).
If you are of the view that your application has been incorrectly referred to a particular TGA office for evaluation, you may make a submission in support of which route of evaluation you consider more appropriate. In making such a submission, you should provide all relevant information that would enable the assessment of the therapeutic good against Schedule 10 of the Regulations.