Bringing a supplement brand to Australia

1. Settle the pathway

The same product can be a supplement or a food in one country and a medicine in Australia. Here, whether it is a medicine, a food or a cosmetic turns on what it contains and how it is presented, starting with its claims. Most supplements sold as medicines are listed medicines: the TGA doesn't evaluate them before they are sold, and the sponsor certifies that they meet the rules (TGA listing). See medicine, food or cosmetic?

2. Appoint an Australian sponsor

Every medicine on the ARTG has a sponsor, the person or company in Australia that is legally responsible for it. The TGA says sponsors must be located in Australia, and that overseas manufacturers can't sponsor medicines for the Australian market. So an overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on its duties. More in our TGA sponsor guide.

3. Check the formula and the claims

A formula built for another market has to be checked against Australia's lists before anything else is spent.

• Ingredients. Each one has to be in the Permissible Ingredients Determination, used for the purposes and within the limits it sets (permissible ingredients). An ingredient that isn't needs its own application first (new ingredient applications).
• Claims. Each indication has to come from the permitted list, and the sponsor certifies that it holds evidence for every one (permitted indications). A claim that sells the product elsewhere may not be one a listed medicine can make here.

If the formula has to change, the change is made before the first listing: see reformulating a supplement.

4. Decide where it's made

• Keep the overseas maker. Each overseas site that carries out a step of manufacture recorded on the ARTG entry needs a TGA GMP clearance, unless the step is exempt. The Australian sponsor obtains it: one clearance per site, per sponsor. There are three routes: a desktop evaluation relying on a mutual recognition agreement, a compliance verification desktop evaluation relying on another regulator's inspection, or an inspection by the TGA. The desktop routes rest on an inspection by a recognised regulator for a human medicinal product, so a supplement factory often needs the TGA's own inspection (GMP clearance).
• Make it in Australia. Every step at a site with a TGA manufacturing licence that covers the dosage form and the step (choosing a supplement manufacturer).

5. Make the Australian label

The label follows TGO 116. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on it too. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. An overseas label won't carry the AUST L number or the Australian sponsor, so the product needs a label of its own here (supplement labelling).

6. List it, then advertise within the rules

The sponsor enters the medicine in TGA Business Services, certifies it and pays the application fee. Once payment is finalised, it goes on the ARTG with its AUST L number, usually showing the next day (TGA listing). From then on, its advertising in Australia follows the Therapeutic Goods Advertising Code, which binds anyone who advertises therapeutic goods, including on social media (advertising a supplement).

Foods and cosmetics

• A food. A product on the food pathway doesn't go on the ARTG: it complies with the Food Standards Code instead, and gives up therapeutic claims (supplements as foods).
• A cosmetic. AICIS regulates the industrial chemicals in cosmetics, and the business that introduces them, by importing or manufacturing, registers with it. The ingredient list follows the Consumer Goods (Cosmetics) Information Standard 2020 (AICIS registration). A product presented mainly to protect the skin from UV is a primary sunscreen: a therapeutic good, generally listed with an AUST L number (skincare and cosmetics).

From our records

• An international skincare brand: formula and evidence work across three products for Australia, two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer.
• Deeply Rooted: an organic essential oil blend for children, made in New Zealand and sold in Australia, with the whole cross-border supply chain managed, delivered in 2025.
• BWellness and Pump Haircare: production runs with imported ingredients, customs and freight, including air freight, managed through to delivery.