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.
Product types
Topics
Latest articles
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TGA seeks public views on stronger vitamin B6 labelling for low-risk medicines
Media releasesWe seeking feedback on a proposal to strengthen the labelling of low-risk products that contain vitamin B6. -
Consent relating to listed medicines that contain whole live microorganisms as an active ingredient
Regulatory decision noticesThis consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989. -
New medicine labelling standards
News articlesNew medicine labelling standards have been published to replace TGO 91 and TGO 92. Sponsors will have a 5-year transition period to update labels.
Latest consultations
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ConsultationThe Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate and pyridoxal 5-phosphate monohydrate.
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ConsultationWe are seeking feedback on proposed changes to the Required Advisory Statements for Medicine Labels (RASML).
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ConsultationWe are seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia.