Selling supplements in Australia: TGA listed complementary medicines

In Australia, the bottle of vitamins on the shelf is, in regulatory terms, a medicine. Most supplements are classed as complementary medicines and regulated by the Therapeutic Goods Administration — and they have to be entered on the national register before they can be sold. It is one of the more structured supplement regimes in the world.

Supplements as complementary medicines

Australia does not treat most supplements as foods. Vitamins, minerals, herbal and many other supplement products fall under the category of complementary medicines, regulated as therapeutic goods by the TGA. That framing shapes everything: the ingredients you can use, the claims you can make, and the route to market all follow medicine-style rules, not food rules.

The ARTG and listed medicines

Therapeutic goods generally must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. For lower-risk complementary medicines, this is typically done as a listed medicine — carrying an AUST L number on the label.

The listed-medicines pathway is built around a key principle: listed medicines can only contain pre-approved, lower-risk ingredients, and can only make certain permitted types of claims. In exchange for staying within those bounds, the listing process is more streamlined than full registration.

Permitted ingredients are the gate

The central constraint is that a listed medicine must use only permitted ingredients — substances the TGA has assessed and allows in listed medicines, often with conditions on amount and purpose. Stray outside the permitted-ingredient list, and the product cannot use the listed pathway.

This makes ingredient selection a market-entry decision from the very start. A formula built without regard to the Australian permitted-ingredient list may have to be reformulated to be listable.

Permitted indications and claims

Claims for listed medicines work from a defined set of permitted indications. Rather than writing free-form claims, manufacturers select from indications the TGA allows for listed medicines, matched to the product. As in other markets, the claim is tied to what is permitted and to the product's composition — not to marketing imagination.

The sponsor and the obligations

Listing is done by a sponsor — an Australian entity responsible for the product. The sponsor certifies that the product meets the requirements and holds the information and evidence to support it. The responsibility, and the recordkeeping behind it, sits with that party.

Because the TGA's permitted ingredients, indications, and requirements are detailed and updated over time, confirm the current rules for your specific product rather than relying on a general summary.

Why structured data matters here too

The listed-medicines pathway is, at heart, a structured-data exercise: confirm every ingredient is permitted and within its conditions, select permitted indications the formula supports, and hold the evidence and composition to back it. When product data is structured — every ingredient characterised, every amount exact — checking listability and assembling the listing is fast. When it is scattered, each step becomes a manual hunt.

The takeaway

Australia regulates most supplements as complementary medicines, and selling them means listing on the ARTG using only permitted ingredients and permitted indications, under a responsible sponsor. The permitted-ingredient gate makes formulation a market-entry decision from the outset — and clean, structured product data is what makes listing repeatable rather than painful.

Lemoniq characterises every ingredient and ties claims to the formula, so checking whether a product fits a market's permitted ingredients and claims — like Australia's listed-medicines pathway — happens as you formulate. We solve this exact problem. See how it works