What this instrument does
The Therapeutic Goods Administration has registered a new federal legislative instrument, Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026. This order sets the labelling standard for prescription medicines in Australia and replaces the previous standard, Therapeutic Goods Order No. 91 (TGO 91), which is repealed by this order.
Commencement
The instrument commenced on 28 September 2026.
Administering authority and enabling legislation
The instrument is administered by the Department of Health, Disability and Ageing under the Therapeutic Goods Act 1989.
What the standard covers
TGO 115 covers the following labelling requirements for prescription medicines:
- What information must appear on labels
- How quantities and ingredients must be expressed
- Specific requirements for different medicine types, including injections, vaccines, and modified-release oral dosage forms
Transitional provision - dual labelling names
A transitional provision in TGO 115 allows dual labelling names for certain ingredients until 30 April 2028. The ingredients covered by this provision are listed in Schedule 2, Part 2 of TGO 115.
Key actions
- Manufacturers, importers, and suppliers of prescription medicines in Australia are required to review TGO 115 in full at https://www.legislation.gov.au/F2026L01311 to understand the new labelling requirements that apply to their products.
- Schedule 2, Part 2 of TGO 115 identifies ingredients for which dual labelling names are permitted only until 30 April 2028 - labels using those names require updating before that date.
- The explanatory statement available on the legislation page at https://www.legislation.gov.au/F2026L01311 provides plain-language guidance on how TGO 115 differs from the repealed TGO 91.
- The Department of Health, Disability and Ageing and the Therapeutic Goods Administration are available for clarification on labelling compliance questions before updated products are distributed.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.