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.
Latest articles
- Update to listed medicine ingredients in March 2023Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
- Changes applying to evaluation of new substances for listed medicinesNew guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
- Update to listed medicine ingredients in November 2022Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.
Latest publications
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2020The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2019In 2019, the TGA conducted 10 pharmacovigilance inspections of Australian medicine sponsors