Sourced from TGA Website
Listed medicines (AUST L) 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.
All listed medicines:
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.
Registered medicines (AUST R) assessed as having a higher level of risk must be registered. The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.
All registered medicines:
Prescription medicines fit into the sub-category of registered medicines as high risk registered products. This group includes all prescription medicines and some specified products such as sterile injectables.
Lower risk registered products do not require a prescription. Products in this category are considered to be lower risk than prescription medicines. However, they still require a high level of scrutiny, for example to ensure adequate labelling for appropriate use.
Examples of products in this category are mild analgesics, cough and cold medicines, and anti-fungal creams.