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:
- PageIngredient requirementsIngredient requirements for labelling and packaging of medicines and biologicals.
- PageStandards for labels and packagingStandards for labels and packaging of medicines and biologicals.
- PageRequired Advisory Statements for Medicine Labels (RASML)Required Advisory Statements for Medicine Labels (RASML).
- PagePermitted indications determinationPermitted indications determination for labelling and packaging of medicines.
- PageCode of practice for tamper-evident packagingInformation on the Code of practice for tamper-evident packaging.
Guidance and resources
- GuidanceBoxed Warning guidanceGuidance to assist sponsors to understand their obligations and prescribers to understand the rationale
- Labelling & 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