If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney-General's ComLaw website, which incorporates the Federal Register of Legislative Instruments (FRLI). Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Medicines are registered or listed on the Australian Register of Therapeutic Goods, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as listed medicines by the Therapeutic Goods Administration. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription medicines, as they:
- may only contain ingredients that have been approved by the TGA as being of low risk, and
- may only make limited therapeutic claims.
In order for a medicine to be listed on the ARTG, it needs to be either
- included in Schedule 4 of the Therapeutic Goods Regulations 1990; or
- listed after the publication of a relevant Therapeutic Goods Listing Notice.
Therapeutic Goods Listing Notices specify particular ingredients that can be used as therapeutically active ingredients in listed products. These notices are approved by a delegate of the Minister under section 9 of the Therapeutic Goods Act 1989. When considered necessary, an advisory committee is consulted before approval.