We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
If you're planning to supply a listed medicine to the Australian market, this is your starting point.
You need to understand how we regulate these products and your ongoing obligations at each stage of the product's lifecycle. This includes choosing the right pathway, holding evidence that supports your medicine's efficacy and meeting all applicable safety and quality requirements.
Being well prepared helps ensures your product meets Australian requirements and avoids delays during the listing process.
Start by learning your responsibilities and planning each stage of your product’s lifecycle.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to listed medicines. You may also have to meet obligations that apply to all medicines and all products.