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If you want market authorisation to sell or supply a prescription medicine, this is where your journey begins.
Market authorisation is the approval given by TGA to supply a therapeutic good in Australia. For prescription medicines it involves entry on the Australian Register of Therapeutic Goods (ARTG) and the generation of an AUST R number for your medicine.
You need to understand how prescription medicines are regulated and what your obligations are at each stage of the market authorisation process.
This includes:
selecting the appropriate registration pathway
preparing supporting evidence
being aware of fees
ensuring your product meets applicable standards and requirements
meeting ongoing responsibilities post-market.
Being well prepared helps ensure your product complies with Australian requirements and reduces the risk of regulatory delays.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and all products.