Medicines definitions
Registered medicines - prescription medicines
Medicines assessed as having a higher level of risk must be registered (not listed). The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.
Prescription medicines fit into the sub-category of registered medicines as High-risk Registered products. This group includes all prescription medicines (ie. medicines with ingredients which are included in Schedule 4 or Schedule 8 of the Standard for the Uniform Scheduling of Drugs and Poisons) and some specified products such as sterile injectables.
Registered medicines - non-prescription (OTC) medicines
Low-risk Registered products are non-prescription medicines. They usually contain ingredients which are described in Schedule 2, Schedule 3, and sometimes Schedule 5 or 6 of the Standard for the Uniform Scheduling of Drugs and Poisons. 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.
Listed medicines (including complementary medicines)
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 (ie. not described in the Standard for the Uniform Scheduling of Drugs and Poisons) 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.
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.
Complementary medicines
Complementary medicines (also known as 'traditional' or 'alternative' medicines) include vitamin, mineral, herbal, aromatherapy and homoeopathic products. See Schedule 14 of the Therapeutic Goods Regulations for a list of the type of substances or products covered by the term, 'complementary'.
Complementary medicines may be either registered or listed, depending on their ingredients and the claims made. Most complementary medicines are listed in the ARTG and some are registered.