Listed Medicine Compliance Reports – June 2025 Update
01 Jul 2025
We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 51 listed medicines, including:
- Medicines containing:
- Valerian (commonly used for sleep and relaxation)
- Lysine hydrochloride (for cold sore management)
- Vitamin D (for bone health claims)
- Medicines making claims about:
- Diarrhoea relief
- Exercise performance
- Maternal postnatal health
- Sunscreens with non-compliant claims about:
- Waterproof properties
- Coverage claims
- Medicines with non-permitted health claims about:
- Depression
- Anxiety
For more information, refer to the database and listed medicine compliance reviews.
What are listed medicines and how are they regulated?
Listed medicines have an ‘AUST L’ number on the label and packaging, and include products such as vitamins and minerals, traditional Chinese medicines, herbal medicines and some sunscreens.
These medicines are included in the Australian Register of Therapeutic Goods (ARTG) and can be sold without being checked by the TGA for safety, quality and effectiveness. Instead, sponsors of listed medicines certify that their medicine meets all the relevant legal requirements prior to selling them.
Listed medicines can only contain ingredients that we have assessed to be of low risk. Their indications (therapeutic uses) can only be selected from a pre-approved list. The indications of a listed medicine on its label, packaging or other advertising material must be included in the ARTG entry of the medicine and must be supported by evidence.
We regularly conduct post-market compliance reviews of selected listed medicines to check for compliance. If a medicine is found to not comply with the legal requirements, we take risk-based and proportionate regulatory actions to address the non-compliance.
We publish the outcomes of these compliance reviews on the Listed Medicine Compliance Reports database on a quarterly basis to allow timely public access to safety or efficacy information of reviewed listed medicines. This assists consumers to make informed decisions when self-selecting listed medicines and avoid purchasing a product that may not be appropriate for them.
