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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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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PageHow to supply a therapeutic good and 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 for sponsors conducting market actions for therapeutic goods in Australia.
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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.
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LegislationThe TGO 112 Order 2024 sets forth the quality standards for MDMA (3,4-methylenedioxymethamphetamine) products, which must comply with specific requirements to ensure safety and efficacy.
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LegislationThe Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 establishes new quality standards for psilocybine products in Australia.
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PageLearn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.
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PageLearn about the regulatory framework for prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
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PageVapes cannot be supplied through any non-pharmacy retail store, such as tobacconists, vape shops or convenience stores in Australia.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.
Storage and handling
Access information about how the storage and handling of products is regulated.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.
Import and export
Access requirements for import and export of therapeutic goods.
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LegislationThe Customs (Prohibited Imports) (Vaping Goods) Approval 2023 establishes import control for vaping goods, including vapes, vape substances, and vape accessories.
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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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FormsImport/export of unapproved therapeutic goods for experimental purposes
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GuidanceGuidance for importation, supply and wholesale requirements for medicinal cannabis.
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PageLegal requirements for importing therapeutic goods into Australia, including unapproved therapeutic goods and controlled substances.
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PageInformation for importers, exporters and manufacturers of medicinal cannabis.
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PageInformation for importers, exporters, and manufacturers about product quality, manufacturing standards, and reporting requirements.
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FormsYou must submit this notice before you import a cannabis vaping device or accessory.
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PageIndividuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met.
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GuidanceFrom 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
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PageInformation for Australian sponsors on manufacturing, supplying and importing MDMA and psilocybine.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.
Product types