Unapproved therapeutic goods

• Access unapproved products (consumers)

  You can access unapproved therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) in limited circumstances. You must speak to a health practitioner first.

• Prescribe an unapproved therapeutic good (health practitioners)

  You can prescribe unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can prescribe and what to do before you apply.

• Supply an unapproved therapeutic good (sponsors)

  Find out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme.

• SAS and AP Online System Information

  Use the SAS and AP Online System to apply to access unapproved therapeutic goods through the Special Access Scheme or Authorised Prescriber scheme.
  
  

• Clinical trials

  Clinical trials involving therapeutic goods may be conducted in Australia under 2 schemes with different notification and approval processes.

• Personal Importation Scheme

  Individuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme.

Medicinal cannabis, vaping goods, MDMA and psilocybin

• Medicinal cannabis hub

  Information about access pathways for medicinal cannabis products.

• Vaping hub

  Find out how we define and regulate vapes in Australia.

• MDMA and psilocybine hub

  Authorised psychiatrists can prescribe MDMA and psilocybine for specific mental health conditions from 1 July 2023.