New medicine labelling standards

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.

Sponsors will have a 5-year transition period to comply with the new 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 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.

Further information on requirements and process to apply to import, supply or export therapeutic goods that do not comply with standards is provided on the TGA website at: Consent to import, supply or export therapeutic goods that do not comply with standards.

Implementation support

We will publish guidance as soon as practicable to support interpretation and implementation of the new standards. Further updates to the guidance will be considered over the coming months and throughout the transition, as required.

Over the first few months of the transition, we will work with stakeholders to ensure there are no unintended drafting errors and may consider an update to the standards if required.

For health professionals and consumers

Changes to medicine labels take time. The 5-year transition will allow sponsors time to update labels to help maintain supply of medicines in the community. New labels will appear gradually as new stock is distributed, and existing stock is sold.

We will provide more information soon about how medicine labels are changing.

More information

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 about the proposed changes and consultation outcomes, visit the consultation page.