Listed medicines
Listed medicines can only contain low risk ingredients and use low level indications.
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.
Latest alerts
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We have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
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The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna).
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Pfizer Australia has advised that the shortage of Bicillin L-A prefilled syringe for injection will continue until mid-2024, so we have approved the importation and supply of a second overseas-registered product, Extencilline benzathine benzylpenicillin 1.2 million unit vial (France), until 30 September 2024.
Latest articles
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Sun Herbal Pty Ltd fined $18,780 for alleged unlawful supply of a complementary medicine
We have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement. -
GMP surveillance inspections and extended validity of TGA GMP certificates
Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates. -
Update to listed medicine ingredients in June 2024
Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.
Latest publications
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The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
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Outcomes following review of consultation submissions
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The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
Open consultations
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Consultation: Future regulation of assistive technologies
The TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
This webpage on the TGA website was printed on 17 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/products/medicines/non-prescription-medicines/listed-medicines