Managing Unlicensed Medicine Supply in Australia
Accessing medicines that are not registered in Australia involves navigating established TGA regulatory pathways, each with distinct eligibility, documentation and compliance requirements. HL Pharma provides end-to-end logistics, regulatory and supply support to help sponsors, CROs, health organisations and clinical teams manage this process compliantly and efficiently.
The challenge of accessing unlicensed medicines
Not all medicines available overseas are registered on the Australian Register of Therapeutic Goods (ARTG). A product may be widely used in Europe, the UK or the USA but not yet assessed by the Therapeutic Goods Administration (TGA). It may have been discontinued locally while remaining available in other markets. It may also be an investigational medicine progressing through clinical development.
In these circumstances, the TGA provides established access pathways that allow eligible organisations and health professionals to source, import and supply unapproved or overseas registered medicines legally, with the appropriate documentation and oversight. Each pathway carries specific compliance obligations and navigating them requires an experienced supply and regulatory partner.
How HL Pharma supports each pathway
HL Pharma is a licensed Australian pharmaceutical wholesaler with an ODC import and export licence, operating under ISO 9001:2015, GDP and GWP standards. We provide practical, compliant supply chain support across the TGA’s main access pathways:
Special Access Scheme (SAS) We support health professionals and organisations requiring individual patient access to unapproved therapeutic goods. Our team manages sourcing, importation, temperature-controlled storage and national distribution to ensure supply is ready when TGA approval is in place.
Authorised Prescriber (AP) arrangements For medical practitioners holding AP authorisation to prescribe a specified unapproved medicine to a class of patients, we provide the reliable, consistent supply model that ongoing prescribing requires — including inventory management and documented chain of custody.
Section 19A imports Where a registered Australian medicine is unavailable, discontinued or in shortage, we can act as Importer of Record and Australian TGA sponsor for overseas-registered alternatives approved under Section 19A of the Therapeutic Goods Act 1989. We manage the full importation and supply process from our Melbourne facility.
Clinical trial and post-trial supply We support investigational medicinal product (IMP) logistics throughout the clinical trial lifecycle, and manage continuity of supply for patients transitioning to post-trial access arrangements.
What our service includes
Across all pathways, HL Pharma provides:
- Global medicine sourcing from a vetted network of licensed suppliers across Europe, the UK, India and the USA
- TGA regulatory sponsorship, acting as Australian sponsor and Importer of Record where required
- Temperature-controlled storage across CRT (15–25°C), refrigerated (2–8°C), frozen (−20°C) and ultra-low (−80°C) environments at our purpose-built Keysborough facility
- Schedule 8 and 9 vault storage with continuous surveillance and full compliance with ODC requirements
- National distribution with documented inventory control and cold-chain integrity
- Pharmacovigilance and regulatory support throughout the access program lifecycle
All services are delivered under our ISO 9001:2015-certified quality management system, with documented controls across sourcing, importation, storage, distribution and supply.
Further information
To discuss your specific access program or supply requirements, contact our team at hlpharma.com.au/contact/ or call +61 3 7036 0141. We work with sponsors, CROs, manufacturers, hospitals and pharmacies who need a partner they can rely on completely. When the supply chain is complex, the regulatory landscape is shifting, or a patient is waiting, precision matters.
HL Pharma supports the compliant management of medicine access pathways, regulatory sponsorship and continuity of supply for sponsors, CROs, manufacturers, hospitals, pharmacies and wholesalers across Australia and the Asia-Pacific region. This content describes HL Pharma’s services and is intended for industry and healthcare organisation audiences. It does not constitute regulatory advice or consumer information about specific therapeutic goods.