If you're planning to supply an unapproved therapeutic good in Australia, you must understand how we regulate unapproved therapeutic goods and what your obligations are under the supply pathways.
Before supplying unapproved therapeutic goods, you are responsible for ensuring that an exemption, approval, or authority is in place.
Being well-prepared helps ensure lawful supply and avoids regulatory delays.
Start be reviewing your responsibilities and selecting the appropriate supply pathway.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
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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PageTherapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageLinks to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.
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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LegislationThe Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
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LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
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LegislationThis Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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LegislationThe Therapeutic Goods (Medical Devices) Regulations 2002 set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.
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LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.