Listed medicines

In general, the risk of a medicine is based on its ingredients and/or its therapeutic indications (intended uses). Because listed medicines can only make low level indications (intended uses) and contain low risk ingredients they are lower risk than registered medicines or assessed listed medicines.

Listed medicines are sold in pharmacies and stores like health food shops and supermarkets. Listed medicines in the Australian Register of Therapeutic Goods (ARTG) are assigned an 'AUST L' identification number that must be displayed on the label.

Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace. Instead, they are automatically included in the ARTG based on a certification by the sponsor (‘product owner’) that their medicine meets applicable legislative requirements in relation to safety, quality and efficacy. This allows for rapid market access compared with registered medicines. The TGA can undertake a compliance review of a listed medicine at any time.

Listed medicines must meet certain low risk criteria. For example they only contain:

• ingredients found in the Therapeutic Goods (Permissible Ingredients) Determination
• indications found in the Therapeutic Goods (Permissible Indications) Determination

The majority of listed medicines include complementary medicine ingredients e.g. vitamins, minerals and plant material. There are also non-complementary medicines (over-the-counter medicines) listed in the ARTG such as some sunscreens.