Medicine labels provide important information to help health professionals and consumers use medicines safely and correctly.
Following consultation, we have introduced 2 new medicine labelling standards to support the safe use of medicines and reflect current labelling practices:
- 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, which sunset on 1 October 2026:
- 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).
Transition arrangements
We understand that sponsors need time to interpret the new requirements and prepare for any updates to medicine labels.
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 the new standards before transitioning to the full standard. These provisions are outlined in Part 6 of the standards and provide additional flexibility during the transition period and reflect alternative labelling practices to those outlined in TGO 91 & 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 under Section 14
Some sponsors currently supply medicines under consents that exempt them from specific TGO 91 and TGO 92 requirements.
To reduce the need for some existing section 14 consents, TGO 115 & 116 include alternative provisions from certain TGO 91 and TGO 92 requirements that sponsors can adopt before transitioning to the full standards.
