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All active and excipient ingredients used in therapeutic goods need an Australian Approved Name (AAN).
Proprietary ingredients are not a type of ingredient and don’t have an approved ingredient name, although the individual ingredients that make up the PI do need AANs.
An Australian approved ingredient name ensures:
- the name clearly and explicitly identifies the ingredient
- only one name is used to specify an ingredient
- consistency of ingredient names with international conventions for example, International Non-proprietary Names (INNs).
Approved ingredient names provide a standardised format for identifying the ingredients used in therapeutic goods.
This allows for consistency and accuracy when:
- applying to register or list a medicine on the Australian Register of Therapeutic Goods (ARTG)
- designing labels and packaging for medicines
- publishing Product Information documents accompanying medicines
- providing Consumer Medicine Information (CMI) documents with medicines
- preparing other promotional material where use of approved terminology is required.
Substances that do not require an approved name
Substances not required to be identified in the formulation of therapeutic goods do not require an approved name.
Examples include:
- chemical and biological starting materials
- some types of growth media
- manufacturing solvents that are removed in the manufacturing process.
Herbal components do not need an approved name unless it is mandatory that they be declared in the Australian Register of Therapeutic Goods (ARTG) entry.
See Herbal ingredients for more information about herbal components.
Trademarked ingredient names
If an ingredient has been registered under a trademark in Australia, the trademarked name cannot be used as an approved ingredient name.
If a trademarked name was adopted as an approved ingredient name, other sponsors would be required to include that name on their labels. This could result in a breach of trademark legislation.
How to get an Australian approved name for an ingredient
All Australian Approved Names (AANs) for ingredients are included in the Ingredients Table found in TGA Business services (TBS).
If your ingredient is not in this list, you can apply for a new ingredient name via Forms for new ingredient name and proprietary ingredients.
You will have to consider
International harmonisation of ingredient names
In 2016 we began a 4-year transition period for medicine companies to show the updated names on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents. This ended on 30 April 2020.
For more information on the international harmonisation of ingredients names (IHIN project) see Updating medicine ingredient names - the overview.