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About listed medicines
Listed medicines have an ‘AUST L’ identification number that must be displayed on the label and packaging.
Examples of listed medicines include:
- vitamins
- Traditional Chinese Medicines
- herbal medicines
- some sunscreens.
Where to buy a listed medicine
People can self-select listed medicines from health food shops, supermarkets and pharmacies and they can be used for self-treatment.
Products available on international websites are not regulated by the TGA. We advise that you do not order medicines, including dietary supplements and herbal preparations, over the internet unless you know exactly what is in it and have checked the legal requirements for its importation and use in Australia. For more information see: Buying health products online has risks.
Supplying a listed medicine on the Australian market
If you want to sell or supply a listed medicine on the Australian market, see Supply a non-prescription medicine.
How we ensure listed medicines are safe
Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace.
Instead, sponsors (product owners) certify that their listed medicine meets requirements in relation to safety, quality and efficacy.
It is an offense for a sponsor to certify that a listed medicine is safe, is of good quality and works as intended when it is not.
Targeted compliance reviews
We can target listed medicines for a compliance review and assess if they meet requirements and standards.
For example, evidence to support indications (proof the listed medicine works as stated on the label) is required to be held by the sponsor and can be checked when requested by the TGA.
Listed medicine ingredients have been pre-assessed by us for quality and safety
Each individual medicine and its formulation is not assessed by the TGA. Instead, listed medicines can only use ingredients that we have assessed as safe and of low risk.
These ingredients are selected from a list (the Therapeutic Goods [Permissible Ingredients] Determination) and can have specific requirements attached to them when used.
For example, if a listed medicine contains caffeine, there are restrictions on the amount that can be included in the medicine.
Indications are pre-worded and selected from a list
Indications, or the stated intended use of a listed medicine can only be selected from a list (the Therapeutic Goods [Permissible Indications] Determination).
The indications used by a listed medicine on their label, packaging or other advertising material must be supported by scientific evidence or evidence of a history of traditional use.
Some medical terms cannot be used by listed medicines
Some medical terms, known as ‘restricted and prohibited representations’ cannot be used by listed medicines.
For example, serious forms of a disease, condition, ailment, or defect like rheumatoid arthritis or depression cannot be mentioned on their labels, packaging or other advertising material. This is because these issues are too serious (extremely high risk) to be self-treated with a listed medicine.
In certain circumstances, a sponsor can request an exemption but must provide substantial evidence to demonstrate that using the term is accurate, balanced and not misleading or likely to be misleading.
Reporting a problem with a listed medicine
If you experience a problem or side effect from a listed medicine, you should seek advice from a health professional and then report a problem or side effect to the TGA.
Suspicion that a product is fake, dangerous, illegal or misleading
If you think a product might be fake, illegal or the contents on its label, packaging or other advertising (e.g., website, social media or radio) is incorrect or misleading, you can report a breach to the TGA.