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Acronym
TGA
Type
Standards Development Organisation

Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government and responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. They regulate medicines, medical devices and biologicals that are used in the Australian healthcare system.

The TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods. As part of their role as regulator, the TGA create regulatory standards that support the safety of therapeutic goods within Australia for the benefit of consumers and patients. Their development of these regulatory standards involves consultation with stakeholders within the process, with final decisions being made within the TGA along with the Federal Health department and ministry.  

Find out more about TGA Guidance and Resources.

Resources

Medicine labels: Guidance on TGO 91 and TGO 92 v2.3

Category
Supplementary Resource
Organisation
TGA
Type
Standard
Version
2.3
Access
Open
Status
Active
Created
March 2021
This document provides extensive guidance for medicine labelling rules TGO 91 and TGO 92. It clarifies and elaborates on the mandatory requirements and provides best practice recommendations for medicine labels.

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Category
Standard
Organisation
TGA
ID
F2023C00458 (C03)
Type
Standard
Access
Open
Status
Active
Created
April 2023
This document sets out the labelling requirements for prescription medicines and composite packs containing a subscription medicine. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.

Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines vC02

Category
Standard
Organisation
TGA
ID
F2023C00456 (C02)
Type
Standard
Version
C02
Access
Open
Status
Active
Created
April 2023
This document sets out the labelling requirements for non-prescription medicines. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.