TGO 116: what changes on your supplement label, and when
The TGA has published TGO 116 to replace TGO 92. Here is what changes, who it affects and how long you have.
In short. TGO 116 replaces TGO 92 as the label standard for non prescription medicines, including listed complementary medicines. TGO 92 sunset on 1 October 2026, and there is a 5 year transition: until then you may comply with either standard. Medicines released for supply after 1 October 2031 must comply with TGO 116.
What changed
TGO 116, the Standard for Labelling of Non-Prescription Medicines, and TGO 115 for prescription medicines replace TGO 92 and TGO 91. They update how label information is presented, reflecting current labelling practice.
Who it affects
Every sponsor of a non prescription medicine, which means every label in a listed range.
The transition
For five years, non prescription medicines may comply with either TGO 92 or TGO 116. Sponsors can also adopt certain provisions of the new standard early. These are set out in Part 6 of the standards and reflect alternative labelling practices the TGA has accepted. The new standards also include alternatives that may reduce the need for some existing section 14 consents.
What to do now
List every label in your range, check each against the new standard, and plan changes into your next print runs so you are not reprinting twice. The TGA has said it will publish guidance to support interpretation and may update the standards if drafting errors turn up in the first months, so keep an eye on its notices.
This article is general information, not legal advice. Check the TGO text before you finalise artwork.
- TGA, New medicine labelling standards, 29 September 2026: tga.gov.au.
- Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026.
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