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Exemptions and exclusions
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Some therapeutic goods do not need to be included in the ARTG because they are excluded or exempt.
Excluded goods are products that may fall within the definition of a therapeutic good, however the TGA has declared the product is not a therapeutic good. For example:
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hair dyes and moisturising anti-dandruff hair care products
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products intended for application to the lips that contain sunscreen
Exempt goods are those that do not need to be in the ARTG under certain conditions. For example:
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certain homeopathic preparations
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medicines that are dispensed or extemporaneously compounded by practitioners
See Therapeutic Goods Act 1989 (the Act) (Section 18) and the Therapeutic Goods Regulations 1990 (the Regulations) (schedule 5 and 5A) for more information on what is considered exempt.
Even if a medicine is exempt from being in the ARTG, it must still comply with all other applicable regulatory requirements.
Question
Have you checked if the product is exempt or excluded?