Check if your health product is a non-prescription medicine

Supplements, vitamins and complementary medicines are often considered therapeutic goods, regulated as non-prescription medicines by the TGA. This means that they must be compliant with TGA legislation and entered onto the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia.

These products can be similar to foods and cosmetics which are not considered therapeutic goods and are not regulated by the TGA.

There are different legal requirements for the manufacture, supply and advertising of therapeutic goods, compared to foods and cosmetics.

What is a therapeutic good

Therapeutic goods are medicines, biologicals and medical devices. The TGA regulates all therapeutic goods, including their advertising. Other products, like cosmetics and foods are not regulated by the TGA. See What are therapeutic goods.

A product is considered a therapeutic good if it is represented to be a therapeutic good and/or likely to be taken for therapeutic use, often through the indications or claims the product uses and the ingredients it contains.

How to tell if you have a therapeutic good

If your product is a therapeutic good, it cannot be a food or cosmetic. Your product can only fall into one classification. 

You need to determine if your product is a therapeutic good yourself. TGA cannot make this determination for you. 

Interactive tools can help you understand if your product is considered a therapeutic good

Use interactive decision tools to help determine what your product is:

• Is my product a therapeutic good?
• The Food-Medicine Interface Tool 
• Is my sports supplement a therapeutic good?
• Is my product a cosmetic? is an Australian Industrial Chemicals Introduction Scheme (AICIS) tool.

Check that your product is not excluded or exempt by legislation

Some products can be ‘declared’ to be therapeutic goods, while others are ‘excluded’ or ‘exempt’ from being included in the Australian Register of Therapeutic Goods (ARTG).

Legislation may exempt your product from being a therapeutic good

Exempt goods are those that do not need to be in the ARTG under certain conditions. For example:

• certain homeopathic preparations
• medicines that are dispensed or extemporaneously compounded by practitioners.

See Therapeutic Goods Act 1989 (the Act) (Section 18) and the Therapeutic Goods Regulations 1990 (the Regulations) (schedule 5 and 5A) for more information on what is considered exempt.

Legislation that declares certain products to be therapeutic goods

The Therapeutic Goods (Declared Goods) Order will tell you if your product is declared to be, or not to be a therapeutic good. Sometimes even if:

• a Food Standard exists for it 
• it has a tradition of use as a food in Australia or New Zealand 
• it’s a deodorant, depilatory cream or soap (amongst others) when used, advertised or presented in particular ways. 

See also Changes to the regulation of sports supplements in Australia.

Legislation that excludes certain products from being a therapeutic good

See the Therapeutic Goods (Excluded Goods) Determination. Some products are excluded from being a therapeutic good when used, advertised or presented for supply in certain ways.

My product is a therapeutic good

Your medicine will need to comply with TGA legislation. See How we regulate for a broad overview. 

See Supply a Non-prescription medicine to access details specific to supplying a non-prescription medicine in Australia.

My product is not a therapeutic good 

If your product is likely to be a food, it will be regulated by your relevant state or territory food regulator, not the TGA. For more information and a list of food regulators by jurisdiction see Food and medicine regulation. 

If your product is likely to be a cosmetic, it will be regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS), not the TGA. Their Cosmetics and therapeutics page contains further information on how they regulate chemicals that are imported or manufactured for an industrial use, including the ingredients in cosmetics.

The AICIS website also offers information on the differences between cosmetics and therapeutic goods.

Cosmetics ingredients labelling is regulated by Australian Competitions & Consumer Commission (ACCC).