TGO 116 has replaced TGO 92: what changes for supplement labels

On 30 September 2026 the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 commenced, and TGO 92, the labelling standard for listed and other non-prescription medicines, was repealed. TGO 116 now sets the label rules for every supplement sold as a listed medicine. A label written to TGO 92 stays compliant on medicine released for supply before 1 October 2031, so nothing on shelf has to change today.

Why it changed, and how

TGO 92 would otherwise have sunset on 1 October 2026. Its replacement was signed on 25 September 2026, registered three days later and commenced on 30 September. Most of TGO 92 carries over: the explanatory statement says the new order principally replicates it with an updated structure, some requirements eased and some strengthened, after a public consultation from 16 December 2025 to 23 March 2026.

TGO 116 is a disallowable legislative instrument, tabled in both houses of Parliament on 12 October 2026, so Parliament can still disallow it. It is in force now and due to sunset on 1 October 2036.

What changed for supplement labels

The order applies to every medicine that isn't a prescription medicine (those have TGO 115), with a list of exclusions, such as export-only and compounded medicines. For a listed medicine, the changes most likely to touch your artwork are these.

• QR codes. A label can carry one, but what it opens must be in the sponsor's control (or be the TGA's information about the medicine), must not contradict the label or the product details, and must work by scanning alone: no login, no personal details, no payment. A code can't replace information the label must carry unless the order says so.
• Small containers. On a small container, the name of a listed medicine can be as small as 1.5 mm.
• Ingredient names. Actives are still named as the Australian Approved Names List has them. New for listed medicines: the main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy.
• Large tablets and capsules. A round tablet more than 13 mm across, a non-round tablet more than 22.4 mm long or 10.5 mm wide, or a capsule more than 24.1 mm long or 9.5 mm wide is a large dosage form. The label needs a swallow-with-water warning and, other than on transparent packaging or a medium container, an actual-size image of the tablet or capsule, marked 'actual size', on the main label or a lid sticker. Small containers are exempt, as are medicines not meant to be swallowed whole, if the directions say so.

What the transition allows

The order's test is the date a medicine is released for supply, not the date it is sold.

• Released for supply before 1 October 2031: the label may follow TGO 116 in full, TGO 92 in full, or TGO 92 with the TGO 116 provisions listed in the order's equivalence table swapped in.
• Released for supply on or after 1 October 2031: TGO 116 in full.

The mix matters: a brand can take up the TGO 116 provisions listed in the order's table now, such as dropping the salt from an active's name, without rewriting the rest of the label. The QR code provisions aren't in that table.

If you are designing a product now

A new product can still launch on a TGO 92 label, but designing to TGO 116 now saves a second round of artwork before 2031. In practice that means:

• Name each active as the Australian Approved Names List has it.
• Check the tablet or capsule against the size thresholds above before the artwork is locked: a large softgel or tablet changes the main label.
• If the pack will carry a QR code, settle what it links to and who controls it first.
• Confirm the name size on any small container.
• Have the label reviewed against the order before print. On Arxi's prenatal chewable, due for dispatch in late October 2026, our label review caught two errors before print.

Advertising follows the label: the Therapeutic Goods Advertising Code now refers to TGO 116. More in our advertising guide and our note on the Advertising Code in 2026.

Where to read more

Our labelling guide sets out everything TGO 116 requires on the label. The TGO 116 section of our TGA listing guide sits inside the full AUST L process, and the listed-medicines pathway shows where the label fits in a project. The order and its explanatory statement are linked below.

Sources

General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.

• Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, its explanatory statement and its registration details, Federal Register of Legislation