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Access pathways for unapproved therapeutic goods

Information on how unapproved therapeutic goods may be accessed under specific pathways.

Unapproved therapeutic goods are products not included in the Australian Register of Therapeutic Goods (ARTG). This means they haven't been assessed by us for safety, quality or effectiveness. 

Certain registered health practitioners may access unapproved therapeutic goods under specific pathways if all other clinically appropriate treatment options on the ARTG have been considered. 

These pathways support access for individual patients or groups under specific conditions and include the: 

  • Special Access Scheme (SAS)
  • Authorised Prescriber Scheme (AP)
  • Clinical Trial (CT) Schemes or
  • Personal Importation (PI) Scheme.

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.  

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