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 31 August 2016.
- TGO 91 - Standard for labels of prescription and related medicines (TGO91)
- TGO 92 - Standard for labels of non-prescription medicines (TGO92)
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.
More information
- Labelling and packaging
- Labelling requirements: information for sponsors
- Medicine packaging definitions for sponsors
- The Black Triangle Scheme
- AUST numbers on medicine labels
- Tips on creating prescription medicine labels compliant with TGO 91
- Warnings on labels of medicines containing neuromuscular blocking agents
- Medicines Advisory Statements Specification updates
- Changes to adrenaline and noradrenaline labels
- Serialisation and data matrix codes on medicines
- Australia's medicine labels are becoming clearer
- Product Information
- PI/CMI search facility
- Product Information
- Improved Consumer Medicine Information (CMI) template
Topics