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
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
The Therapeutic Goods Administration is part of the Health Products Regulation Group