Unapproved therapeutic goods are products that are not included in the Australian Register of Therapeutic Goods (ARTG). These products can be manufactured, exported, imported, or supplied in Australia under strict regulatory conditions.
If your product is not covered by an exemption, or is not on the ARTG, it can only be supplied though one of these pathways:
- the Special Access Scheme (SAS)
- the Authorised Prescriber (AP) Scheme
- Clinical Trial (CT) Schemes or
- the Personal Importation (PI) Scheme.
You are responsible for ensuring that an exemption, approval, or authority is obtained prior to supplying unapproved therapeutic goods.
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.
Supply
Understand your obligations to manage the ongoing supply of products.
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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 about the Clinical Trial Notification (CTN) scheme.
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PageInformation on how to supply a therapeutic good and how to get started. Find out how to confirm your product is a therapeutic good, how it's regulated and if it needs to be entered in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation about special circumstances that may allow a medicine to be imported, exported or supplied in Australia.
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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.
Import and export
Access requirements for import and export of therapeutic goods.
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PageInformation on the legal requirements for exporting medicines, medical devices and human substances from Australia.
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PageInformation on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.
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PageLegal requirements for importing therapeutic goods into Australia, including unapproved therapeutic goods and controlled substances.
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PageIndividuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met.