Short answer: TGO 91 and TGO 92 expire on 1 October 2026, but the TGA has allowed a transition of up to five years, so existing labels do not need to be scrapped overnight. New artwork is the natural moment to check against the new rules.
Anyone designing packaging for a therapeutic good in Australia works within the Therapeutic Goods Orders. TGO 91 covers prescription and related medicines, and TGO 92 covers non-prescription medicines, the category that includes many over-the-counter products and listed complementary medicines. Both orders sunset on 1 October 2026, and replacement standards have been developed through public consultation.
What the TGA has said about timing
The TGA ran a consultation on proposed changes to medicine labelling from 16 December 2025 to 23 March 2026, after extending the original closing date. Its consultation page states that both new and existing medicines may comply with either the requirements in TGO 91 or TGO 92, or the new standards, for five years. Sponsors may also adopt specific new provisions before the full transition ends.
In practice, that means a brand owner will see old and new label formats on shelf side by side for some time. Australian Pharmacist has made the same point for pharmacy staff, noting that both formats should be expected while existing stock is replaced.
Changes flagged for labels
The TGA’s January 2026 consultation paper set out the proposed direction. Three themes matter most to a designer working on a supplement or OTC pack:
- Allergen and substance declarations. The paper proposed a new wheat declaration, broader marine mollusc declaration, and listing individual tree nuts rather than a generic “tree nuts” statement. It also proposed a lower gluten threshold, from 20 ppm to 3 ppm, with the source declared. These are proposals from the consultation paper, so confirm the final wording in the registered standards before relying on them.
- Units. “Microgram” is to be spelled out rather than abbreviated as “µg”, to reduce the risk of it being misread as “mg”. Australian Pharmacist lists this among the changes taking effect under the new standards.
- Machine-readable codes. The paper described modernising the rules to support QR codes, and planned updated guidance on machine-readable codes and on design principles for differentiating medicines.
Australian Pharmacist also reports that the new requirements apply to the container and any other packaging, not to Consumer Medicine Information or Product Information.
Why this is a design problem, not only a regulatory one
Allergen statements that grow from one generic line to several named ingredients take space. Spelling out “microgram” makes dose lines longer. On a small bottle label or a blister card, those additions compete with the brand, the claims panel and the barcode. The earlier a label is planned around these mandatories, the less likely they are to be squeezed into the last few millimetres of the layout.
A practical checklist for the next artwork round
- Confirm whether the product is regulated under TGO 92 (or TGO 91) and which TGA pathway it sits under.
- Read the final registered standards, not only the consultation paper, since proposals can change.
- Audit current labels for allergen wording, unit abbreviations and any “µg” usage.
- Allow panel space for longer declarations in the dielines before the brand layout is locked.
- Ask your regulatory adviser to sign off the final text before it goes to print.
For the wider design picture in this category, see the supplement packaging design guide, and the compliance checker for a quick orientation on what a pack needs to carry.
General information to help you plan, not legal or regulatory advice. The TGA is the authority on therapeutic goods labelling. Always confirm current requirements with the TGA or your regulatory adviser before you print.