Critical and compassionate medical supply in Australia
HL Pharma is the operational partner hospitals, clinicians and sponsors rely on to secure critical and compassionate-use medicines into Australia, from first enquiry through to delivery at the hospital pharmacy.
By coordinating Section 19A imports and navigating all relevant TGA pathways, including the Special Access Scheme (SAS), Authorised Prescriber (AP), Managed Access Programs (MAPs) and compassionate-use arrangements, HL Pharma creates clear, defensible supply routes that withstand hospital governance and regulatory scrutiny.
For programs requiring heightened oversight, HL Pharma integrates specialist regulatory guidance, GDP‑aligned storage, validated cold‑chain distribution, and audit-ready documentation at every stage of the supply chain, so decision-makers can proceed with confidence and patients receive timely access to treatment.
Our Critical Medical Supply Solutions
Emergency and Urgent Medicine Shortage Support in Australia
When essential medicines are in short supply, recalled or subject to unexpected demand, HL Pharma helps maintain continuity of treatment. We work with procurement, pharmacy, and clinical teams to confirm clinical requirements, identify suitable alternatives, and source stock through our network of manufacturers and suppliers. Once a product is confirmed, we coordinate import, release, and distribution so that medicines and medical devices reach hospitals, clinics, and pharmacies across Australia as quickly as practicable, with clear documentation at each stage.
For up‑to‑date insights on critical and high‑impact medicine shortages in Australia, clients should consult the TGA Medicine Shortage Reports Database, which tracks current shortages, forecast issues and discontinuations.
Veterinary teams can also view our veterinary-specific shortage insight here.
Unregistered Medicines and Compassionate Access Supply (SAS and Authorised Prescriber)
For medicines that are not commercially available in Australia, HL Pharma supports access through Therapeutic Goods Administration pathways. We source and import overseas registered or unlicensed medicines from recognised manufacturers, then supply them under the Special Access Scheme, Authorised Prescriber pathways, Section 19A arrangements and company-managed access and compassionate access programs.
Section 19A Pharmaceutical Distribution Services in Australia
HL Pharma manages end-to-end Section 19A pharmaceutical distribution in Australia, covering sourcing from approved overseas manufacturers, TGA approvals, importation, temperature-controlled storage and national distribution to approved clinical sites. Each program is supported by full batch traceability and audit-ready documentation, giving hospitals, pharmacies and procurement teams a clear, compliant supply route from approval through to final distribution.
TGA Regulatory Guidance, Section 19A Compliance and Managed Access Programs
Critical and compassionate supply must sit within a clear, defensible regulatory framework. HL Pharma coordinates the importation and distribution of medicines and devices supplied under SAS, AP, Section 19A, Managed Access Programs and related TGA mechanisms, and manages the logistics element of biological import licences and controlled drug permits.
Where a situation requires a more detailed regulatory strategy or formal submissions, we engage specialist regulatory partners and integrate their advice into the supply plan. This ensures access remains workable for clinicians while respecting the conditions, monitoring and reporting obligations attached to each product.
Cold Chain Logistics and Controlled Drug Distribution for Schedules 2, 3, 4, 8, and 9
Many critical medicines are temperature-sensitive, high-value, or controlled substances. HL Pharma provides validated cold chain logistics and temperature-controlled pharmaceutical warehousing for refrigerated, frozen, and ultra-low-temperature products, using qualified packaging, temperature data loggers, and temperature-controlled transport.
Where urgent or compassionate use relates to a clinical trial, HL Pharma can support importation, validated storage and national distribution of investigational and post-trial medicines. We assist with extension studies, rollover arrangements and post-trial access, aligning logistics with TGA approvals and access pathways to support continued treatment.
Sponsors and CROs use HL Pharma as an integrated depot and distribution partner for critical medical supplies in Australia, New Zealand and the Pacific Islands, including support during shortages and compassionate access for patients once trials have ended.
Why Choose HL Pharma for Urgent & Compassionate Medical Supply Australia?
Experience, speed and full-spectrum compliance in urgent and compassionate medical supply logistics. HL Pharma brings together urgent medicine supply, critical medical supply logistics, compassionate access solutions and full regulatory compliance under one roof.
Our licensed operations span every medicine schedule, including controlled drugs, from a validated, temperature-controlled facility in Melbourne. Traceability, audit readiness and recall preparedness are built into every process, supporting your governance requirements and external inspections reliably.
A TRUSTED PARTNER FOR URGENT AND COMPASSIONATE SUPPLY IN AUSTRALIA
If you need support with critical medical supply, shortage response or compassionate access, HL Pharma can help structure and deliver a practical, compliant solution. Contact us to discuss your requirements and how we can support your next urgent or compassionate supply program.