Ingredient name requirements
Ingredient name requirements for labelling and packaging of medicines and biologicals.
Therapeutic goods in Australia must use approved names in their formulations.
Medicines need to use approved names on labels as set out in standards for labels and packaging.
We have updated some medicine ingredient names used in Australia to align with names used internationally. There are requirements for the labelling of some updated medicine ingredient names.
Not all medicine ingredient names were changed. A list of the old and updated medicine ingredient names is available at our List of affected ingredients.
- PageTake care when prescribing, dispensing, and administering medicines as labels will start to show sole names.
- PageThe list shows the medicine ingredient names that are changing. The list is split into active ingredients and excipient ingredients.
Guidance and resources
- GuidanceThis guidance is for manufacturers, sponsors and providers of biologicals and human cell and tissue (HCT) materials.
- BlogWant to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.
- NewsFind out about new transition arrangements for dual labelled ingredient names.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Famtozinameran) Labelling Exemption 2023NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Consultation: International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient namesClosed onConsultationThe TGA is seeking views on ingredient names that must be displayed as both the old and new ingredient name on medicine labels.
- Consultation: Regulatory options to potentially allow references to the TGA in therapeutic goods advertisingClosed onConsultationThe TGA is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).