Guidance tool for access to unapproved therapeutic goods

3 July 2017

Health practitioners are encouraged at all times to use therapeutic goods that have been entered on the Australian Register of Therapeutic Goods (ARTG) as these have been evaluated for quality, safety and effectiveness (or performance).

However, we recognise there are times where it may be necessary to use a therapeutic good that is not on the ARTG.

There are a number of pathways available to access unapproved therapeutic goods, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme.

To help health practitioners determine which of these pathways, if any, is appropriate to be used in any given circumstance, we have developed a tool to guide you down the appropriate access pathway.

In conjunction with this tool, you are encouraged to familiarise yourself with the Special Access Scheme Guidance for Health Practitioners and Sponsors and Authorised Prescriber Scheme Guidance for Medical Practitioners, Human Research Ethics Committees and Specialist Colleges.