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Supply and distribution for unapproved therapeutic goods

Information about how unapproved therapeutic goods are supplied, imported and exported in Australia. 

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.

Import and export

Access requirements for import and export of therapeutic goods.

  • Export

    Page
    Information on the legal requirements for exporting medicines, medical devices and human substances from Australia.

  • Import

    Page
    Information on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.

  • Importing therapeutic goods

    Page
    Legal requirements for importing therapeutic goods into Australia, including unapproved therapeutic goods and controlled substances.

  • Personal Importation Scheme

    Page
    Individuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met.
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