Registered medicines

28 April 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:

• must display an 'AUST R' number on the label as proof of registration
• are evaluated as either 'high risk' or 'low risk' registered.

Prescription (high risk) registered

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.

Non-prescription (low risk) registered

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.