First question: is it a medicine or a food?
The Therapeutic Goods Administration regulates complementary medicines: vitamins, minerals, herbal, homoeopathic and nutritional supplements presented as therapeutic goods. Most capsule, tablet and liquid supplements with a health indication are listed medicines (AUST L) under the Therapeutic Goods Act 1989. Registered complementary medicines (AUST R) are the higher-evidence minority, and assessed listed medicines (AUST L(A)) sit between.
A product can instead be a food under the Food Standards Code: protein powders, most sports nutrition, formulated supplementary foods and formulated supplementary sports foods (Standard 2.9.3 and 2.9.4), meal replacements and fortified foods. A food cannot carry therapeutic claims; a medicine cannot be labelled like a food. The classification turns on presentation and claims as much as composition, and it has to be settled with a regulatory adviser before artwork starts, because the two back panels share almost nothing.
What has to be true before the label can be designed
- The product is listed on the ARTG by its sponsor (the Australian entity responsible for it) and has an AUST L number.
- Every ingredient is in the Permissible Ingredients Determination, and any warning statements that Determination requires for those ingredients are known.
- Every indication (what the product is for) is drawn from the Permitted Indications Determination for listed medicines. Free-text health claims are not available to listed medicines.
- The Required Advisory Statements for Medicine Labels (RASML) have been checked for the ingredients and dose, and the required statements are in hand.
- Manufacture is by a licensed manufacturer under Good Manufacturing Practice, which drives batch coding and expiry.
None of that is the designer's job, but all of it lands on the label. The brief should arrive with the ARTG entry, the indication wording, the ingredient list with quantities in the exact format the sponsor wants, the RASML statements, and the sponsor details. Without them the first artwork round is fiction.
The standard: TGO 92 today, TGO 116 from here
Labels for non-prescription medicines, which includes listed complementary medicines, have been governed by Therapeutic Goods Order No. 92. It sunset on 1 October 2026. The replacement, the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, was published on 29 September 2026 alongside TGO 115 for prescription medicines.
The transition is five years. During it a non-prescription medicine may comply with either TGO 92 or TGO 116, and sponsors may adopt particular TGO 116 provisions (set out in Part 6 of the Order) in place of the linked TGO 92 provisions before transitioning fully. All medicines released for supply after 1 October 2031 must comply with TGO 116. The TGA has said guidance on TGO 116 is being written and that the TGO 92 guidance (Labelling medicines to comply with TGO 91 and TGO 92, version 2.6) remains valid in the meantime.
What the consultation proposed, and why it matters for the pack
The TGA consulted on the replacement standards from January 2026. The final Order should be read directly, but the proposals that most affect label design were these:
| Area | Proposal |
|---|---|
| Large tablets and capsules | Non-prescription medicines with large solid oral dosage forms must carry the warning 'Warning: large [tablet/capsule]' when they exceed set dimensions (round tablets over 13 mm diameter; other non-capsule forms over 22.4 mm long or 10.5 mm wide; capsules over 24.1 mm long or 9.5 mm wide), with an actual-size image of the dosage form next to the warning on non-transparent containers and 'Swallow with water' in the directions. Not required for chewables and lozenges with clear directions not to swallow whole. A shorter transition of about two years was proposed for this item. |
| Microgram | Display 'microgram' in full wherever possible rather than µg, which is misread as mg. |
| Warnings on listed medicines | Listed medicines must display all warning statements prominently, including those required by the Permissible Ingredients Determination. |
| Name of the medicine | A defined 'distinguishing mark' related to the brand may be part of the name presentation; slogans, taglines and spatial separation of naming elements are permitted for non-prescription medicines but not registered ones. |
| Active ingredient prominence (guidance) | On the main label of the primary pack, active ingredient text should be at least 50 percent of the medicine name height, or 3 mm, whichever is larger. |
| Text size for listed medicines in small containers | Confirmed at 1.5 mm minimum, correcting an inconsistency in TGO 92. |
| Colour contrast (guidance) | A contrast ratio of at least 4.5:1 between text and background, checked with a contrast tool. |
| Batch and expiry | Keep the Batch and Exp prefixes; the TGA flagged embossed expiry dates as hard to read. |
The large-dosage-form warning is the one that changes a pack visibly: a capital-W warning on the label and a life-size picture of the capsule beside it. Many supplement capsules are over 24 mm. If a product is near the threshold, check its actual dimensions before the front panel is designed, because the warning has to live somewhere.
The main label
The main label is wherever the medicine name is most conspicuous. A carton and a bottle each have one, and the mandatory main-label information must be oriented the same way. Under TGO 92 (and TGO 116 keeps the principle) the main label carries:
- The name of the medicine, complete and uninterrupted. Trademarks, graphics and other text must not break the name, and nothing may come between the name and the active ingredients. The relationship between name and actives is a single cohesive unit.
- The names and quantities of the active ingredients, in a consistent location and presentation across the range. For salts, hydrates and solvates the form is named; quantities use the formats the Order specifies.
- The dosage form (tablet, capsule, oral liquid), written in the Order's style, for example 'effervescent tablet' rather than 'tablets, effervescent'.
- The quantity in the pack (number of tablets or capsules, volume of liquid).
- The AUST L number. It is required by the Regulations rather than the Order itself, and may be smaller than the general minimum text size.
Elsewhere on the pack
- Indications, drawn from the permitted indications.
- Directions for use, including dose and frequency.
- Warning statements: those required by RASML, those required by the Permissible Ingredients Determination, and any required by the Order itself. Keep out of medicine of children and similar statements use the exact mandated wording.
- Batch number and expiry date, each with its prefix (Batch, Exp), in a colour contrasting with the background unless embossed on foil where the Order allows.
- The sponsor's name and Australian address, and for imported goods the sponsor remains responsible.
- Excipient declarations where the Order requires them (certain sugars, sulfites, benzoates, gluten-related and other listed substances).
- Storage conditions.
- Critical Health Information. Mandatory in tabulated form for most registered non-prescription medicines; recommended for listed medicines, and if used on a listed medicine it must follow the same format. Absence claims (sugar free, free from) do not belong in the CHI table.
Text size and legibility
Required information must be at least 1.5 mm, measured on the lower-case x-height. Active ingredient names and quantities on registered medicines must be at least 3 mm on the main label of the primary pack (2.5 mm on small containers). The AUST L number may be 1 mm. Text must contrast strongly with the background; the TGA recommends sentence case, warns that all-capitals is harder to read, and reserves capitals for statements RASML mandates in capitals. Colour may differentiate variants in a range but never alone, and colour coding (a colour that means something) should only be used where already established.
Claims and advertising on the pack
The label is an advertisement under the Therapeutic Goods Advertising Code. For a listed medicine that means: only the permitted indications, no claims of being safe or without side effects, no references to serious diseases outside the permitted list, no endorsements by health professionals, no comparative claims that cannot be substantiated. Evidence for every indication must be held by the sponsor before listing. And the pack cannot imply that the TGA has approved or endorsed the product; the AUST L number is a listing, not an approval, and some sponsors are required to carry a statement to that effect in advertising.
A working layout
A supplement bottle label or carton, laid out to the rules.
| Panel | Content |
|---|---|
| Front (main label) | Brand. Medicine name as one unbroken unit, with active ingredients and quantities immediately beneath or beside it at the Order's minimum size. Dosage form and pack quantity. AUST L number (often at the base). The large-dosage-form warning and actual-size image where TGO 116 requires it. Optional: the permitted indication in short form, a distinguishing mark. |
| Side or back panel 1 | Indications in full. Directions for use. Warnings in the mandated wording, prominently. Storage. |
| Side or back panel 2 | Active ingredients repeated if the brand wants a full formulation table. Excipient declarations. Sponsor name and address. Batch and Exp with prefixes in the print window. Barcode in the lower right with clear quiet zones. |
| Carton (if used) | Repeats the main label. Carton is the primary pack; the bottle label is the container label; both need their own main label. |
What fails review
- A health claim that is not a permitted indication, or an indication worded differently from the Determination.
- A graphic or tagline sitting between the medicine name and the active ingredients.
- Active ingredients at the wrong size, in a different place on each variant, or missing the salt or form.
- µg instead of microgram, where TGO 116 wants it in full.
- A RASML or Permissible Ingredients warning missing, abbreviated or reworded.
- No AUST L number on the label, or a number that does not match the ARTG entry.
- Batch or expiry without the prefix, or embossed on clear material where it cannot be read.
- A large capsule with no warning or actual-size image once the product is labelled to TGO 116.
- Colour as the only cue between variants in a range.
- A product labelled as a food making a therapeutic claim, or a medicine labelled with a nutrition information panel like a food.
Questions people ask
Most are listed, not approved. A complementary medicine must be listed on the Australian Register of Therapeutic Goods by its sponsor, use only permitted ingredients and permitted indications, and carry its AUST L number on the label. Registered (AUST R) complementary medicines are assessed for efficacy and are the minority.
The Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, published 29 September 2026. It replaces TGO 92, which sunset on 1 October 2026. Labels may comply with either until 1 October 2031.
1.5 mm (lower-case x-height) for required information under TGO 92 and TGO 116. Active ingredients on registered medicines must be at least 3 mm on the main label of the primary pack. The AUST L number may be as small as 1 mm.
Under the TGO 116 proposals, non-prescription medicines with tablets or capsules over set dimensions (for example capsules over 24.1 mm long or 9.5 mm wide, round tablets over 13 mm) must carry 'Warning: large capsule' or equivalent, an actual-size image on non-transparent packs, and 'Swallow with water' in the directions. Check the final Order text and transition date.
No. Listing is not approval, and implying TGA endorsement breaches the Therapeutic Goods Advertising Code. The AUST L number is the listing reference.
Usually a food, regulated under the Food Standards Code (often Standard 2.9.4 for formulated supplementary sports foods), which means a nutrition information panel and no therapeutic claims. Presentation and claims can tip a product into the medicine category; settle the classification before designing.
Sources
- New medicine labelling standards, TGA, 29 September 2026
- Medicine labelling requirements: information for sponsors, TGA
- Labelling medicines to comply with TGO 91 and TGO 92, TGA guidance v2.6 (March 2026)
- Medicine labels: proposed changes to rules for the new standards replacing TGO 91 and TGO 92, TGA consultation paper v1.2 (January 2026)
- Required Advisory Statements for Medicine Labels (RASML), TGA
- Australian Regulatory Guidelines for Complementary Medicines (ARGCM), TGA
- Permitted indications for listed medicines, TGA
Published . Last reviewed . Next scheduled review . Regulatory content is re-checked against the primary sources above at each review. See our editorial standards.
