Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.
Information held in the ARTG includes:
There were approximately 62,600 products on the Australian Register of Therapeutic Goods as at January 2011.
Medicines 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.
Low-risk registered products are non-prescription medicines. 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/cold preparations, anti-fungal creams.
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 established 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.
They show that the medicines are accepted by the Therapeutic Goods Administration for supply in Australia and are included in the Register. The number is printed on the outer packaging so that it can be seen easily.
AUST R medicines are assessed for safety, quality and effectiveness. They include all prescription only medicines and many over-the-counter products such as those for pain relief, coughs and colds and antiseptic creams.
Prescription only medicines do not display their purpose on the label as the decision for using them lies with a doctor; however, over-the-counter medicines must have a purpose displayed.
AUST L medicines are much lower risk self-medication products. They are used for minor health problems and are reviewed for safety and quality. They include sunscreens over SPF4 and many vitamin, mineral, herbal and homoeopathic products. A purpose must be included on the label.
As with many aspects of the regulatory framework, there are situations where special policies have been developed in response to the needs of particular people or circumstances. Information on these policies and the relevant procedures can be found at:
These schemes cannot be used to facilitate the commercial supply of therapeutic goods.
MIMS does not have details for every registered or listed medicine. Absence of an AUST R or AUST L number against a pack does not mean that one does not exist. A pack may have more ARTG entries than are listed in the MIMS information. Please see the Therapeutic Goods Administration (TGA) website for more information.