Listed medicines are usually considered to be relatively benign, so the regulations allow for sponsors to 'self assess' their products in some situations. The majority of listed medicines are self-selected by consumers and used for self-treatment.
They are all unscheduled medicines with well-known low-risk ingredients, usually with a long history of use, such as vitamin and mineral products or sunscreens. These are assessed by the TGA for quality and safety but not efficacy.
must only contain ingredients that are included in the Therapeutic Goods (Permissible Ingredients) Determination.
Listed medicines are assessed by the TGA for quality and safety but not efficacy. This means that the TGA has not evaluated them individually to see if they work.
This does not mean that they do not work. It simply means that the TGA has not evaluated them individually to see if they work. It is a requirement under the Act that sponsors hold information to substantiate all of their product's claims. For example, sunscreens can be a listed product yet, they must have complied with testing under the Australian standard for sunscreens.
It is a requirement under the Therapeutic Goods Act 1989 that sponsors hold information to substantiate all of their product's claims.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.