What commenced, and what it replaces

A Therapeutic Goods Order made under section 10 of the Therapeutic Goods Act 1989 is the standard a medicine’s labels must meet: what goes on the primary pack, any intermediate packaging and the container, where it goes and how big it is printed. Two new ones were dated 25 September 2026 and registered on 28 September: the Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026 and the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026. Each explanatory statement says the order commences on 30 September 2026.

They repeal TGO 91, the prescription labelling order, and TGO 92, the non-prescription one. The explanatory statement for TGO 115 describes the change in one line: The Order principally replicates the requirements of the Former Order, with appropriate updates made to the structure and order in which the requirements are set out. The Therapeutic Goods Administration consulted from 16 December 2025 to 23 March 2026 and received 110 online responses and 8 by email, according to both statements.

  1. 16 December 2025 to 23 March 2026TGA public consultation on replacing the sunsetting orders
  2. 25 September 2026TGO 115 and TGO 116 dated
  3. 28 September 2026Both registered on the Federal Register of Legislation
  4. 29 September 2026TGA publishes its notice, “New medicine labelling standards”
  5. 30 September 2026Both commence; TGO 91 and TGO 92 repealed
  6. 1 October 2026The date TGO 91 and TGO 92 would otherwise have sunset
  7. 1 October 2031Medicines released for supply on or after this date must comply with the new orders
From TGO 115 and TGO 116 as made (dates, sections 45 and 36), their explanatory statements (consultation, commencement, sunset date) and the TGA’s notice of 29 September 2026.

The transition is the part a print business will be asked about first. Section 45 of TGO 115 says Medicines to which this instrument applies that are released for supply before 1 October 2031 may comply with one of the following instead of the provisions of this instrument, and the first option is simply TGO 91. The second is TGO 91 with selected provisions of the new order swapped in, from a table of 22 items; TGO 116 has the same structure in section 36, with TGO 92 and 21 items. The TGA’s notice puts it plainly: Sponsors will have a 5-year transition period to comply with the new standards. It also says New labels will appear gradually as new stock is distributed, and existing stock is sold.

What is new on the artwork, and what carries over

Both explanatory statements list a few requirements that strengthen requirements compared with the old orders. We checked each against the last compilations of TGO 91 and TGO 92, and the new wording is not in them. Several are print instructions in all but name. Section 30 of TGO 115 says that where potassium is the principal active ingredient in an injection, the name of the medicine, the active ingredient and the quantity or proportion of the active ingredient must appear in red colour text. Section 35 requires modified-release oral medicines to carry Do not crush or chew or words to that effect; TGO 116 asks the same of non-prescription ones, as Swallow whole. Do not crush or chew.

New on the artwork

  • Potassium injections: name, active ingredient and quantity in red text TGO 115 s 30
  • Modified-release oral: “Do not crush or chew” TGO 115 s 35; TGO 116 s 26
  • Single-dose injections of 1 mL: volume of fill “in 1 mL”, or “/1 mL” if space is short TGO 115 s 39
  • Large tablets and capsules (non-prescription): an actual-size image and a warning TGO 116 s 27
  • QR codes: where the code may lead and what it may not replace TGO 115 and 116 s 9

Carried over from TGO 91

  • A GS1 machine readable code carrying the GTIN on the primary pack, except starter packs
  • The medicine’s name on at least three non-opposing sides of a carton
  • A 70 × 30 mm space for the dispensing label
  • A 1.5 mm default minimum text size
  • “Warning: Paralysing agent” in black text on a fluorescent red or warm red background
“New” means listed as strengthened in an explanatory statement, or absent from the last compilation of the old order when we searched it; the single-dose 1 mL rule is from the TGO 115 statement, and the crush-or-chew wording is absent from both old compilations. Carried-over items are in TGO 91, Compilation No. 4, and in TGO 115.

The orders also loosen a few things. Both statements list an active ingredient name on the main label without its salt, hydrate or solvate, on conditions. The TGO 115 statement adds that batch number and expiry date do not need a prefix, and the TGO 116 statement a medicine name on the main label that may be interrupted by a distinguishing mark.

Large tablets: a picture on the pack, drawn to size

Section 27 of TGO 116 is, in our view, the requirement most likely to change a carton layout. It applies to an oral medicine that is a round tablet more than 13 mm across, another tablet or pill 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. Unless the pack is transparent or a medium container, the main label or lid sticker on the primary pack must carry an image of the actual size of the pill, tablet or capsule, with the words “actual size” and the warning “Warning: large [name of dosage form]” beside it. The directions for use must say to swallow it with water. A small container is exempt, and so is a medicine not meant to be swallowed whole whose label says so.

The size thresholds in TGO 116 section 27, drawn to scale against each other Three outlines at a common scale: a round tablet 13 millimetres across; a non-round tablet 22.4 by 10.5 millimetres; a capsule 24.1 by 9.5 millimetres. A medicine larger than any one of these dimensions is covered. 13 mm round tablet 22.4 × 10.5 mm other tablet or pill 24.1 × 9.5 mm capsule
The thresholds in TGO 116 section 27(1). A medicine is covered when it is more than any one dimension (diameter for a round tablet; length or width for the others). Drawn to the same scale as each other, not at actual size on your screen; outline shapes are illustrative.

What a QR code on a medicine may lead to

Section 9 of both orders is described in both explanatory statements as new mandatory requirements for information reached through a QR code. In the non-prescription order, the information must be in the control of the sponsor or link to information about the medicine on the TGA’s website; the prescription order allows the TGA link only where it permits it. In both, the information must not be inconsistent with the label or the medicine’s product details, and, unless the order permits it, the code must not replace anything the label is required to carry.

“be accessible by scanning the code only, and not require a person to log in, provide any personal information or make a payment to access the information.”

TGO 115 and TGO 116, section 9(1)(c), on the information a QR code on a medicine label leads to.

One word that moved: “debossed”

Both orders require label information in a colour that contrasts strongly with the background, with an exception for a batch number or expiry date that is formed in the material rather than printed. The exception reads differently in the two new orders. TGO 115 covers that information when that information is embossed or debossed and not printed, as TGO 91 did. TGO 116 covers it when that information is embossed and not printed. The last compilation of TGO 92 said when that information is embossed or debossed and not printed.

TGO 92 (old, non-prescription)“embossed or debossed and not printed”
TGO 116 (new, non-prescription)“embossed and not printed”
TGO 115 (new, prescription)“embossed or debossed and not printed”
Paragraph 8(4)(e) of TGO 115 and TGO 116 as made; the matching paragraph of TGO 92, Compilation No. 2.

The TGO 116 explanatory statement does not mention the difference, and we do not know whether it is deliberate. The TGA’s notice says: Over the first few months of the transition, we will work with stakeholders to ensure there are no unintended drafting errors and may consider an update to the standards if required. Until 1 October 2031 a non-prescription pack can comply with TGO 92 instead, so nothing printed today turns on it.

What it means for a print business

Our view. This is a remake, not an overhaul, and the five years are real. Under the orders a medicine released for supply before 1 October 2031 may comply with either standard, and the TGA itself expects new labels to arrive as stock turns over. A label or carton printer should not be selling anyone an urgent reprint on the strength of 30 September.

Where the new orders do bite, they bite in prepress. An actual-size image only works if nobody scales the panel to fit, so it belongs on the proof checklist beside the barcode verification, not in a designer’s head. Red text for potassium injections is a colour specification that has to survive proofing and press. And a QR code is no longer just a link: the orders say what it may lead to, and a dynamic code whose redirect sits with a third-party platform is worth raising with the sponsor against the words “in the control of the sponsor”. That is our reading of the text, and a question for the sponsor, not a ruling.

The practical move is to ask, at each artwork revision, which order the client is complying with. A job that mixes old and new provisions is allowed, but only through the swaps listed in the transition tables, and the TGA says it will publish guidance as soon as practicable.