Notice this page is intended for registered healthcare professionals, hospital purchasing officers, and practice managers only. The information provided relates to regulatory pathways and compliance processes governed by the Therapeutic Goods Administration (TGA) and is not intended for general consumers.
Accessing Medicines Not Registered with the TGA
In Australia, the Therapeutic Goods Administration (TGA) approves medicines for general use. However, access to unlicensed (unapproved) medicines is permitted under specific regulatory schemes, including the Special Access Schemes (SAS), the Authorised Prescriber Scheme and Clinical Trials.
These medicines are often required when:
- No suitable TGA-approved product exists
- A locally registered medicine is temporarily unavailable
- A treatment is only licensed overseas for rare or complex conditions
In such cases, regulated pathways allow the lawful import and supply of unlicensed medicines to meet patient needs.
Regulated Pathways to Access Unlicensed Medicines
Special Access Scheme (SAS)
This scheme allows healthcare professionals to prescribe unapproved medicines to individual patients under defined circumstances. Access is granted under three categories:
SAS Category A: For emergency use in patients who are seriously ill or life-threatened. This is a notification-only process.
SAS Category B: Requires formal TGA approval prior to supply.
SAS Category C: A streamlined, notification-only process for medicines with a well-established safety profile and defined indications.
Authorised Prescriber Scheme
Specialist healthcare providers may be granted authority to prescribe specific unlicensed medicines to particular groups of patients without needing to apply for each individual case.
Clinical Trials
Unapproved medicines may be supplied for use in TGA-approved or ethics-approved clinical trials. This pathway supports research and development of new therapies under controlled conditions.
How HL Pharma Can Help
HL Pharma is a fully licensed pharmaceutical wholesaler with a global network of trusted and approved suppliers spanning over 15 countries. We provide full support throughout the regulatory and importation process for healthcare professionals navigating these pathways.
We operate under GWP and GDP, hold ISO 9001:2015 certification, and are supported by an electronic Quality Management System (eQMS) certified to ISO 9001:2015.
Trusted Supply Network
Our global partnerships support healthcare professionals and institutions in navigating TGA-regulated access pathways for medicines unavailable in Australia.
Shortage Solutions
HL Pharma supports healthcare providers and pharmacists in navigating the regulatory processes for medicines unavailable in Australia.
- Special Access Schemes
- Authorised Prescriber pathways
- Section 19A approvals (temporary supply of unapproved goods to address shortages)
Controlled Substances and Biologicals
Some unlicensed medicines are classified as controlled drugs or biologicals. HL Pharma holds an Office of Drug Control licence and all necessary permits to import these categories of products legally. Where required, we liaise directly with the Department of Agriculture and relevant authorities to obtain additional authorisations.
Your Partner in Unlicensed Medicine Access
HL Pharma supports clinicians and healthcare organisations in navigating the regulatory pathways for access to medicines not registered in Australia. Our team brings practical experience across the Special Access Scheme, Authorised Prescriber pathway, early and managed access programs, and clinical trial supply requirements. We assist with documentation, regulatory submissions and compliance processes, helping healthcare professionals maintain focus on patient care..