Australian regulatory guidelines for complementary medicines (ARGCM)

Version 6.0, October 2016

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13 October 2016

ARGCM Part D: Registered complementary medicines

This guidance is provided for an -applicant' - the person who submits an application for a new registered complementary medicine. You (the applicant) may or may not become the sponsor of the new registered medicine if it is approved.

This guidance applies to proposed registered medicines that are eligible for evaluation by the TGA's Complementary Medicines Branch (CMB) - refer to Route of evaluation for complementary medicines.

Note: where a medicine is/would be subject to Schedules 4, 8 and 9 of the Poisons Standard (SUSMP) it will be evaluated as a prescription medicine - refer to Australian Regulatory Guidelines for Prescription Medicines.

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