Australian regulatory guidelines for complementary medicines (ARGCM)
Version 6.0, October 2016
ARGCM Part A: General guidance on complementary medicine regulation in Australia
Part A provides an overview of the regulatory framework for complementary medicines in Australia. The guidance is provided for sponsors, healthcare professionals and the general public.
Information is provided on:
- what complementary medicines are
- legislation applicable to complementary medicines
- the different types of complementary medicines and ingredients
- approved terminology
- exempt medicines
- practitioner medicines and exemptions
- medicine presentation
- changes to information in the Australian Register of Therapeutic Goods (ARTG) for complementary medicines
- post market regulatory activity
- complementary medicine interface issues
- appeal mechanisms for decisions made under the Therapeutic Goods Act 1989.