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If you're planning to bring an assessed listed medicine to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage of the medicine's lifecycle. This includes choosing the right Australian Register of Therapeutic Goods (ARTG) entry pathway, preparing evidence, and meeting quality and safety requirements for the medicine.
Being well prepared helps ensures your product meets Australian requirements and avoids delays getting your product to market.
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 assessed listed medicines. You may also have to meet obligations that apply to all medicines and all products.