Labelling requirements for the International Harmonisation of Ingredient Names project
Ingredients included in the International Harmonisation of Ingredients Name (IHIN) project have labelling and packaging requirements.
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.
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PageRead about dual labelled medicine ingredient names transitioning to show only the new name.
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PageTake care when prescribing, dispensing, and administering medicines as labels will start to show sole names.
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PageThe list shows the medicine ingredient names that are changing. The list is split into active ingredients and excipient ingredients.
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PageOver time we've updated some medicine ingredient names used in Australia to align with names used internationally.
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PageInformation for sponsors on the transition period for the move to sole medicine ingredient names for most affected ingredients.
Guidance and resources
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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PageInformation about types of ingredients, restrictions on use and why they are scheduled.
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Latest consultations
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ConsultationWe are seeking feedback on the proposed temporary labelling exemptions for paracetamol.
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ConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.
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