Labels are intended to communicate information that is critical to the prescriber, dispenser and consumer for the quality use of medicines. If it is difficult to identify medicines, or to locate and understand critical safety information, then medication errors are more likely to occur.
The TGA introduced new labelling requirements for medicines supplied in Australia on 30 September 2026.
- 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.
There is also a labelling standard for biologicals:
-
PageLabelling requirements for ingredients that are included in the International Harmonisation of Ingredient Names (IHIN) project.
-
PageStandards for labels and packaging of medicines and biologicals.
-
PageLearn about Required Advisory Statements for Medicine Labels (RASML).
-
PagePermitted indications determination for labelling and packaging of medicines.
-
PageInformation on the Code of practice for tamper-evident packaging.
Guidance and resources
-
GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
Related links
Topics