Sponsors must hold evidence to support any indications and claims they make about their product.
You need to have this information at the time you apply to list your medicine in the ARTG and for the whole time it is entered in the ARTG.
Indications:
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are statements that specify the therapeutic use of the goods
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must be included in the ARTG entry for the medicine
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must be supported by evidence
Claims:
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do not convey a specific therapeutic benefit (for example, ‘25% more’ or ‘new formula’)
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do not need to be included in the ARTG; but
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must be supported by evidence
Different indications require different types of evidence. See the Evidence Guidelines for further information. You can find the evidence requirements for sunscreens in the ARGS.
You must hold your evidence at all times while your medicine is listed in the ARTG and ensure that it is relevant and up-to-date. We may ask you to provide your evidence as part of a post-market review of your product.