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.
General information
Learn about how products are regulated.
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PageAll biologicals must be classified before they can be included on the Australian Register of Therapeutic Goods (ARTG).
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PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
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PageFind out how applications to register an OTC medicine are categorised into five levels based on risk.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
Definitions and classification
Understand how products are defined and classified.
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Decision treeUse this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.
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GuidanceGuidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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LegislationThis Determination specifies a number of articles that are not medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.