Listed and assessed listed medicines may only use ingredients found in the Permissible Ingredients Determination. The Determination outlines specific requirements of use for individual ingredients. This includes how an ingredient can be used, and any restrictions that must be complied with such as a label advisory statement.
More information
- Permissible ingredients determination
- Mandatory requirements for an application to vary the Permissible Ingredients Determination
- Application requirements for new substance for use in listed medicines
- Overview of compositional guidelines and templates
- List of compositional guidelines
- Requirements for microorganism characterisation in listed medicines and registered complementary medicines
- Evaluation of substances for use in listed medicines: application user guide
- Pre-clearance application for animal-derived ingredients
- Garcinia gummi-gutta: ingredient suitable for use in lower risk medicines
- Listed medicines that are required to be tested for the presence of Aristolochic acids
- Oral probiotics indicated for vaginal conditions
- Folate and folic acid for use in listed medicines
- Listed medicines at risk of containing safrole
- Listed medicines requiring a pregnancy warning statement
- Listed medicines containing caffeine
- Information sources that could assist regulators with market authorisation of complementary/ herbal medicine ingredients