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Accessing unapproved products

Educational materials

The Australian Medical Association (AMA) and Pharmaceutical Society of Australia (PSA) are hosting Continuous Professional Development (CPD) modules on the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme. These modules also include information on access to medicinal cannabis.

There are a number of ways that patients can gain access to products that have not been approved for use in Australia.

  • Authorised prescribers
    Medical practitioners can be granted authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients
  • Special access scheme
    Arrangements to provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis
  • Clinical trials
    Clinical trials involving therapeutic goods may be conducted in Australia under two schemes
  • Personal import scheme
    Individuals can import unapproved therapeutic goods for personal use in some circumstances
  • Accessing medicines during a medicine shortage
    Sponsors can be granted authority to import and supply medicines in the interests of public health in the event of a medicines shortage or to allow early access
  • Access to medicinal cannabis products
    Guidance on providing appropriate patients with access to medicinal cannabis products as an unapproved drug through the Special Access Scheme or Authorised Prescriber Scheme