The Therapeutic Goods Administration (TGA) has made a declaration under sub-section 7(1) of the Therapeutic Goods Act 1989(link is external) (the declaration) to clarify that certain sports supplements are regulated as medicines (see Changes to the regulation of sports supplements in Australia).
This tool will help you determine if your sports supplement is a therapeutic good under this declaration and therefore should be included in the Australian Register of Therapeutic Goods (ARTG).
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Question 1– Intended use
The declaration applies to products that are both:
- claimed or implied to be for the improvement or maintenance of physical, or mental performance in sport, exercise or recreational activity AND
- used, advertised or presented for supply for, or in a way that is likely to be taken for, therapeutic use.
Is your product represented for therapeutic use in sport, exercise or recreational activity?
Question 2 - Substances or ingredients identified in the declaration
From 30 November 2020, sports supplements that are presented for therapeutic use (Question 1) are covered by the declaration if they contain any of the following higher risk substances or ingredients:
- a substance in a Schedule to The Poisons Standard (the SUSMP), irrespective of whether it was added as an ingredient or is a constituent of an ingredient (such as a herbal extract) that is added to the product
- a substance in the World Anti-Doping Code’s Prohibited list (prohibited from use in sports) that is included in the product as an ingredient
- a relevant substance specified in the declaration included in the product as an ingredient. The relevant substances currently are:
- dendrobium (Dendrobium nobile)
Does your product include a substance or ingredient identified in the declaration?
Question 3 – Dosage form
From 30 November 2023, sports supplements that are presented for therapeutic use (Question 1) are covered by the declaration if they are in a dosage form of a pill, tablet or capsule.
Is the dosage form a pill, tablet or capsule?
Your product may not be a therapeutic good
Based on your answers, your product does not appear to be a therapeutic good under the declaration and may be classified as a food. However, note that there might be other reasons your product could be considered to be a therapeutic good (see Food-Medicine Interface Guidance Tool).
Please refer to Food Standards Australia New Zealand (FSANZ) for further information about how your product may be regulated as a food.
If your product is already included in the ARTG and on the basis of the assessment in this tool your product is not a therapeutic good, you may consider cancelling your entry from the ARTG. If you choose not to cancel your product at this time, the TGA may investigate the regulatory status of your product in the future and elect to take action to remove it from the ARTG.
Your sports supplement may be a therapeutic good
Based on your answers, your product may be a therapeutic good under the declaration and may need to be included in the Australian Register of Therapeutic Goods (ARTG).
See Overview of supplying therapeutic goods in Australia for further information.
Including your product in the ARTG
If your product is a therapeutic good, your next step will be to submit an application to include your product in the Australian Register of Therapeutic Goods (ARTG). You can do this through TGA Business Services (TBS) - see Getting started with the TGA for more information. There are fees associated with an application to include a product on the ARTG as well as ongoing charges to keep it there – see schedule of fees and charges.
Once your product is included on the ARTG, you may import, export, manufacture and supply the product.
Where to go for more help
You may wish to seek the services of a Regulatory Affairs Consultant to assist you with submitting an application.
You can also contact the Complementary and OTC Medicines Branch.
This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.
If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.
The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.