When a needed medicine is not on the Australian Register of Therapeutic Goods, access can still be possible through the TGA's named-patient pathways. GNH USA is a US-based, WHO GDP-certified distributor that sources unlicensed, orphan and hard-to-find medicines from regulator-approved markets worldwide — supporting patients and prescribers in Australia under the Special Access Scheme and Authorised Prescriber arrangements, subject to TGA requirements.
The Australian context
How unlicensed medicines reach patients in Australia
The ARTG and unregistered medicines
Most medicines supplied in Australia must be on the Australian Register of Therapeutic Goods (ARTG). A product that is not on the ARTG is considered unapproved, but the TGA provides pathways to supply it to a specific patient where clinically justified.
Special Access Scheme (SAS)
The SAS allows a healthcare practitioner to access an unapproved therapeutic good for a single patient. It is structured around notification and approval categories that reflect the patient's circumstances and the product's risk profile.
SAS Category A, B and C
Category A typically covers seriously ill patients and operates by notification. Category B generally requires TGA approval before supply. Category C covers certain lower-risk, established products by notification. The applicable category and its conditions are determined under TGA requirements.
Authorised Prescriber scheme
Under the Authorised Prescriber pathway, an eligible practitioner may be authorised to prescribe a specified unapproved medicine to a class of patients in their care, without a separate application for each individual patient.
Personal importation
Australia's personal importation arrangements allow individuals to import certain medicines for their own use or that of an immediate family member, within the conditions and limits set by the TGA. Some categories of medicine are excluded.
Practitioner-led, documentation-driven
Across these pathways the prescribing decision and regulatory responsibility sit with the Australian practitioner. GNH USA's role is to source and supply the medicine compliantly once the appropriate access basis is in place.
What we do
A worldwide sourcing partner for Australian named-patient supply
Global sourcing reach
We identify regulator-approved sources across many markets worldwide, helping locate medicines that may be unavailable or discontinued in Australia.
WHO GDP-certified
Procurement and handling follow Good Distribution Practice, supporting product integrity from the source market through to delivery.
Validated cold chain
Temperature-sensitive medicines are shipped through monitored, validated lanes designed to protect the product end to end.
Documentation support
Each shipment is accompanied by the documentation needed to support an Australian access pathway, subject to TGA requirements.
Orphan and rare-disease focus
We routinely handle orphan, low-volume and hard-to-find medicines where conventional supply lines fall short.
Practitioner-aligned
We work alongside prescribers, pharmacies and patients so supply fits the access basis the practitioner has established.
The process
From request to delivery in Australia
- Step 01
Request
A patient, caregiver, pharmacy or prescriber tells us the medicine needed and the Australian access pathway in view.
- Step 02
Verification
We review the request and supporting documentation, such as a prescription or practitioner details, before proceeding.
- Step 03
Sourcing
We identify a suitable regulator-approved source market for the unapproved medicine.
- Step 04
Import and QA
The medicine is procured and prepared for import, with quality checks and documentation aligned to TGA requirements.
- Step 05
Delivery
After internal QA, the medicine ships to Australia via validated, GDP-compliant logistics.
Start a request
Request a named-patient medicine for Australia
Compliance stays with the prescriber
GNH USA does not make prescribing decisions or determine eligibility under the Special Access Scheme or Authorised Prescriber scheme. Those responsibilities rest with the treating Australian practitioner. We focus on sourcing and supplying the medicine compliantly once the access basis is in place, subject to TGA requirements.
Request a medicine
Questions
Named-patient supply in Australia — FAQs
FAQ
Frequently asked questions
What is the Special Access Scheme (SAS)?
The SAS is a TGA pathway that lets a healthcare practitioner access a medicine that is not on the ARTG for an individual patient. It uses notification and approval categories that reflect the patient's circumstances and the product's risk, with the applicable conditions determined under TGA requirements.
How do the SAS categories differ?
Category A generally applies to seriously ill patients and works by notification. Category B usually requires TGA approval before supply. Category C covers certain established, lower-risk products by notification. Which category applies, and its conditions, are decided under TGA requirements.
What is the Authorised Prescriber scheme?
It allows an eligible practitioner to be authorised to prescribe a specified unapproved medicine to a class of patients in their care, without a separate application for each patient. The authorisation and its scope are subject to TGA requirements.
Can a patient import a medicine themselves?
Australia's personal importation arrangements allow individuals to import certain medicines for personal or immediate-family use within TGA conditions and limits. Some categories of medicine are excluded, so patients should confirm the rules that apply to their situation.
Where does GNH USA source the medicine from?
GNH USA is US-based and sources from regulator-approved markets worldwide, choosing a suitable source for each request. All handling follows WHO GDP, and temperature-sensitive products move through validated cold-chain lanes.
Who is responsible for regulatory compliance?
The treating Australian practitioner is responsible for the prescribing decision and for meeting the relevant access pathway conditions. GNH USA supplies the medicine compliantly and provides supporting documentation, subject to TGA requirements.
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