Unapproved therapeutic goods are products not included in the Australian Register of Therapeutic Goods (ARTG). This means they haven't been assessed by us for safety, quality or effectiveness.
Certain registered health practitioners may access unapproved therapeutic goods under specific pathways if all other clinically appropriate treatment options on the ARTG have been considered.
These pathways support access for individual patients or groups under specific conditions and include the:
- Special Access Scheme (SAS)
- Authorised Prescriber Scheme (AP)
- Clinical Trial (CT) Schemes or
- Personal Importation (PI) Scheme.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.
Special Access Scheme
Learn about and apply for the Special Access Scheme.
-
PageYou 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.
-
PageYou can prescribe unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can prescribe and what to do before you apply.
-
PageUse the SAS and AP Online System to apply to access unapproved therapeutic goods through the Special Access Scheme or Authorised Prescriber scheme.
-
GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
-
PageFind out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme.
-
ServiceYou can apply to access unapproved therapeutic goods for individual patients through the Special Access Scheme (SAS).
Authorised Prescriber Scheme
Learn how prescribers can apply to the Authorised Prescriber Scheme.
-
PageYou 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.
-
PageYou can prescribe unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can prescribe and what to do before you apply.
-
User guideA step-by-step guide to completing the form
-
PageFind out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme.
-
ServiceAs a medical practitioner, you can apply to access an unapproved therapeutic good to a class of patients with the same condition.
Clinical trial schemes
Find how to access unapproved goods through clinical trials.
-
GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
-
PageOn 2 May 2024, the Minister for Health and Aged Care announced an investment of $18.8 million to progress the National One Stop Shop for clinical trials and health research.
-
User guideThe user guide for the Clinical Trial Notification (CTN) form has been updated to reflect the recent updates to the online CTN form.
-
PageFind out about the Clinical Trial Notification (CTN) scheme.
-
PageFind webinars and presentations about Australian clinical trials.
-
FormsCTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor.
-
PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.
-
PageA sponsor’s guide to the expectations for the contents of an Investigator’s Brochure.
-
PageWe are currently in the process of reviewing the CTA scheme.
-
PageSummarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
Personal importation scheme
Learn how to access unapproved goods through the personal importation scheme.
-
PageIndividuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met.