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Labelling requirements
The TGA introduced new labelling requirements for medicines supplied in Australia on 30 September 2026.
The two medicine labelling standards 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.
These standards replace the following standards:
- Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), and
- Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).
Guidance is being developed to help you comply with the new requirements. In the meantime, guidance on TGO 91 and TGO 92 remains valid, see Labelling medicines to comply with TGO 91 and TGO 92.
Transition arrangements
Sponsors have a 5-year transition period to comply with TGO 115 and TGO 116.
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, in place of linked provisions in TGO 91 and 92, before transitioning completely to the new standards. Part 6 of each standard sets out these provisions, which provide greater flexibility during the transition period. They allow alternative labelling practices to those outlined in TGO 91 and TGO 92 that the TGA has determined are acceptable.
All medicines released for supply after 1 October 2031 must comply with the new standards.
Consent to supply medicines that do not comply with a standard
Australian medicines that do not comply with the labelling standards cannot be released for supply without prior consent. In specific circumstances, the TGA may consider giving consent under section 14 of the Therapeutic Goods Act 1989 for individual products.
Sponsors can apply for this consent using the relevant application form. Where consent is given, the TGA publishes a record of these decisions on the TGA website.
Note that, TGO 115 and TGO 116 include alternative provisions for certain requirements in TGO 91 and TGO 92 that sponsors may adopt before transitioning to the full standards. These provisions may reduce the need for some section 14 consents for medicines that do not comply with TGO 91 and TGO 92.
Consultation
We consulted with stakeholders before introducing TGO 115 and TGO 116. We thank stakeholders for their feedback which helped inform the development of the standards. For more information, visit the consultation page.
Further information
For questions about prescription medicine labels, email TGO115@health.gov.au.
For questions about non-prescription medicine labels, email TGO116@health.gov.au.