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Assessed listed medicines must be labelled and advertised in a clear, truthful, and accurate way.
Labels and packaging must provide essential information such as product name, Australian Register of Therapeutic Goods (ARTG) number, ingredients, directions for use, and any warnings.
Advertisements for assessed listed medicines must:
- promote safe and proper use of a listed medicine
- not mislead, deceive or create unrealistic expectations
- support informed health care choices.
Indications (health claims) for assessed listed medicines may only be made following our evaluation and approval.
We monitor advertising to ensure compliance and promote safe and informed use. You must ensure that your assessed listed medicine is labelled and promoted responsibly to protect consumers and meet legal obligations.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to assessed listed medicines. You may also have to meet obligations that apply to all medicines and all products.