Listed medicines: the TGA pathway most supplements take

In short

• Most vitamins, minerals, herbal medicines and other supplements sold in Australia are listed medicines with an AUST L number: the TGA's lowest-risk tier of medicine.
• A listed medicine can only use ingredients from the TGA's pre-approved list and low-level claims from its permitted indications, with evidence held for every claim.
• The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after.
• From our records, design to production order has taken 32 days to 12 weeks. The listing itself is quick once the work behind it is done.
• The TGA's fees from 1 July 2026: $1,063 to apply for a listing, then an annual charge of $1,566 for each listed medicine.

What a listed medicine is

A listed medicine is the TGA's lowest-risk tier of non-prescription medicine. It can only use ingredients from the TGA's pre-approved list and make low-level health claims from its permitted indications. The TGA doesn't individually evaluate it before it is sold: the sponsor (an Australian resident, or a company doing business in Australia with a representative who lives here) certifies that it meets the rules and holds the evidence for its claims, and the TGA can review it at any time after. Medicines that need stronger claims go through assessed listing (AUST L(A)), where the TGA assesses efficacy before sale, or registration (AUST R), where it evaluates safety, quality and efficacy first. Our TGA listing guide sets out the differences, the steps and the fees.

What we do on the listed pathway

• Ingredients and indications first. Every ingredient must be in the Permissible Ingredients Determination, used only as it allows, and every indication must come from the Permissible Indications Determination. Both change: there have been three ingredient determinations in 2026 alone. We check every ingredient, its form and its dose at the brief, before the formula, so nothing has to be designed twice. What each indication allows, and the evidence behind it, is in our claims and indications guide.
• The evidence behind every claim. The sponsor certifies at listing that it holds evidence for every indication and claim, and the TGA can ask to see it. Our evidence packages run from a single ingredient to formulas of 13 or more, including a complex herbal capsule built around KSM-66® ashwagandha and a prenatal built on native Kakadu plum.
• The listing, and keeping it current. We secure the listing and update it when the product changes: a kava pain relief cream after a preservative change, a joint formula to keep it current, and Pump Haircare's upgraded formula with a full new listing package.
• The label. Since 30 September 2026, labels follow TGO 116, which replaced TGO 92 (TGO 92 labels remain an option for medicines released for supply before 1 October 2031). On Arxi's prenatal, our label review caught two errors before print.
• Stability. A program to support the expiry date on the label: 24 months on recent capsules, 36 months on The Belly Solution's powder, and a protocol designed to support a three-year expiry on an eye-health tablet. What the TGA expects is in our stability testing guide.
• Regulatory work on a retainer. Since 2024 we have run an international skincare brand's Australian regulatory work, now in its third year.

How long it takes

The TGA's step is quick: once an application passes validation and its fee is paid, the medicine goes on the Australian Register of Therapeutic Goods with its AUST L number. The time is in the work before lodging. From our records, design to production order has taken 32 days for a complex herbal capsule, under seven weeks for an eye-health formula and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. The full process, step by step with the TGA's fees, is in our guide to TGA listing, and the stages that set the pace are in how long it takes to develop a supplement.