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Accessing unapproved products

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 importation scheme
    Individuals can import unapproved therapeutic goods for personal use in some circumstances
  • Medicine shortages: Information for health professionals
    What to do if your patient’s medicine is in shortage and general medicine shortage information
  • 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
  • Medicinal cannabis
    Information about access pathways for medicinal cannabis products
  • Nicotine vaping products
    The law regulating imports of nicotine vaping products is changing from 1 October 2021