There are two medicine labelling standards that reflect the different risks and information needed on labels for prescription and non-prescription medicines:
- Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026
- Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026.
TGO 115 and TGO 116 commenced on 30 September 2026, and replaced TGO 91 and TGO 92, respectively. A 5-year transition period applies to both standards.
During the transition period:
- prescription medicines may comply with either TGO 91 or TGO 115
- non-prescription medicines may comply with either TGO 92 or TGO 116.
Sponsors may also adopt certain provisions in TGO 115 and TGO 116 before transitioning to the applicable standard.
All medicines released for supply after 1 October 2031 must comply with TGO 115 or TGO 116.
Guidance is being developed to help sponsors comply with the new requirements in TGO 115 and TGO 116. In the meantime, guidance on TGO 91 and TGO 92 remains valid, see Labelling medicines to comply with TGO 91 and TGO 92.
Other Australian legislative requirements also apply to medicine labels and packaging. For example, the Therapeutic Goods Regulations 1990 includes requirements for displaying the AUST R, AUST L(A) or AUST L number on medicine labels. Sponsors must ensure their labels and packaging comply with all relevant requirements.
There is also a standard for biologicals:
- Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021.
Guidance and resources
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.