Based on the answers you have given your product may be a complementary medicine and a regulated therapeutic good. You can find out more about complementary medicines on the overview of complementary medicines webpage and information relating to permissible ingredients.
Overview
In Australia, medicines containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Therapeutic Goods Act 1989.
Useful links
If you are new to therapeutic goods regulation you should also familiarise yourself with:
- Overview of supplying therapeutic goods in Australia
- A summary of supplying therapeutic goods in Australia (video)
- Excluded therapeutic goods
- Responsibilities of becoming a sponsor in Australia
- Fees and charges
- Advertising and labelling and packaging requirements
Next steps
Once you have familiarised yourself with the information at the above links, you may wish to apply to have your complementary medicine to be entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:
- Consider engaging a regulatory affairs consultant
- Create a TBS account
- Gather the documents you will need to support your application to enter your medicine on the ARTG.