Assessed listed medicines
Assessed listed medicines can only have low risk ingredients, but they can have higher level indications (intended uses) than listed medicines because the TGA has assessed the evidence for the medicine’s indications. People can self-select these medicines from shops and pharmacies.
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.
- The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- These requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023.
- Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989, and accompanying guidelines are intended to come into effect in January 2023.