What this instrument covers
The Therapeutic Goods Administration has registered the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026. The order was registered on 28 September 2026 and is now in force. TGO 116 replaces the previous labelling standard, TGO 92, which is repealed by Schedule 4 of this order.
Scope of the new standard
TGO 116 sets out how non-prescription medicines must be labelled. The standard covers:
- Information required on main labels
- Requirements for primary packs and intermediate packaging
- Requirements for small containers
- Rules for specific product types, including sunscreens, eye medicines, homeopathic preparations, and modified-release oral dosage forms
Transitional provision for dual labelling names
Schedule 2 of TGO 116 includes a transitional provision. Certain dual labelling names are permitted to be used until 30 April 2028. After that date, full compliance with the new names is required.
Declared substances
Schedule 1 of TGO 116 lists the substances that the standard requires to be declared on labels.
Key actions
- Manufacturers, importers, and suppliers of non-prescription medicines can download the full text of TGO 116 at https://www.legislation.gov.au/F2026L01312 and check current product labels against the new requirements.
- Schedule 2, Part 2 of TGO 116 sets out which ingredient names fall under the transitional dual labelling provisions - those names can be used until 30 April 2028, after which the new names are required.
- Schedule 1 of TGO 116 lists the substances that the standard requires to be declared on labels - labels are required to include all listed declarations.
- The Department of Health, Disability and Ageing is available to provide guidance on compliance for specific products.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.