Assessed listed medicines
Assessed listed medicines have low risk ingredients, but slightly higher risk indications (intended uses) than listed medicines.
About assessed listed medicines
Assessed listed medicines have an ‘AUST L(A)’ identification number that must be displayed on the label and packaging.
Assessed listed medicines are similar to listed medicines. They differ in that assessed listed medicines can make intermediate indications where listed medicines cannot, and can include a 'TGA assessed claim' on their label and advertising.
As such, assessed listed medicines require a pre-market evaluation by the TGA.
Where to buy an assessed listed medicine
People can self-select assessed listed medicines from health food shops, supermarkets and pharmacies.
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 an assessed listed medicine on the Australian market
If you want to supply an assessed listed medicine on the Australian market, see Supply a non-prescription medicine.
How we ensure assessed listed medicines are safe
Assessed listed medicines are not individually evaluated by the TGA for quality and safety before they are supplied in the marketplace. Instead sponsors (product owners) certify that their assessed listed medicine meets requirements in relation to safety and quality.
TGA does assess efficacy pre-market.
It is an offense for a sponsor to certify that an assessed listed medicine is safe and of good quality when it is not.
Targeted compliance reviews
We can target assessed listed medicines for a compliance review and assess if they meet the certified requirements.
For example, evidence to support manufacturing quality is held by the sponsor and can be checked when requested by the TGA.
Assessed listed medicine ingredients have been pre-assessed by us for quality and safety
Each individual medicine and its formulation (ingredients) is not assessed by the TGA. Instead, assessed 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 an assessed listed medicine contains kelp powder, there are restrictions on the amount that can be included if it is to be taken orally (as opposed to applied to the skin).
Indications require a pre-market evaluation by the TGA
Indications used by an assessed listed medicine are evaluated by the TGA before they go onto the market.
This means that the indications on the label or other advertising material of an assessed listed medicine have been checked by the TGA to ensure they are accurate and work as stated.
Some medical terms cannot be used by assessed listed medicines
Some medical terms, known as ‘restricted and prohibited representations’ cannot be used by assessed 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 an assessed 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 an assessed listed medicine
If you experience a problem or side effect from an assessed 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.
- Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
- New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
- Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.