Assessed listed medicines

In general, the risk of a medicine is based on its ingredients and/or its therapeutic indications (intended uses). Assessed listed medicines are lower risk than registered medicines, but slightly higher risk than listed medicines. Assessed listed medicines are sold in pharmacies and stores like health food shops and supermarkets. Assessed listed medicines included in the Australian Register of Therapeutic Goods (ARTG) are assigned an 'AUST L(A)' identification number that must be displayed on the label.

Like other listed medicines, assessed listed medicines are included in the ARTG following self-certification by the sponsor (‘product owner’) of the safety and quality of the medicine. They can only contain:

• ingredients listed in the Therapeutic Goods (Permissible Ingredients) Determination

Unlike listed medicines, assessed listed medicines can make indications that are not permitted for listed medicines. As such, assessed listed medicines require a pre-market evaluation by the TGA.

Assessed listed medicines can also include a ‘TGA assessed claim’ on their label and other advertising indicating the TGA has assessed the evidence for the medicine’s indications.