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If you want market authorisation to sell or supply a boundary or combination product, this is your starting point.
Market authorisation is the approval given by TGA to supply a therapeutic good in Australia.
You need to understand how we regulate these products and your obligations to legally manufacture and supply them.
This includes:
choosing the right regulatory pathway
preparing evidence to support regulatory compliance
fees and annual charges
complying with safety, quality, and efficacy requirements
meeting on-going post-market responsibilities.
Learn about your responsibilities and plan ahead. Being prepared helps ensure your product meets Australian requirements and avoids delays getting your product to the market.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to boundary and combination products. You may also have to meet obligations that apply to all products.