Managed Access Programs (MAPs) for Medicines in Australia, New Zealand and Asia-Pacific
HL Pharma partners with pharmaceutical and biotechnology sponsors, contract research organisations, hospitals and healthcare providers to support Managed Access Programs across Australia, New Zealand and the wider Asia-Pacific region.
These programs can help eligible patients access medicines that are unapproved, not yet commercially available or not routinely reimbursed, where there is an identified clinical need and appropriate regulatory and clinical oversight.
HL Pharma coordinates sourcing, importation, temperature-controlled storage and distribution, together with support for applicable TGA access pathways, Office of Drug Control licensing and permit requirements, and Importer-of-Record services across Australia and New Zealand. This gives sponsors and hospitals one accountable partner from regulatory coordination through to final delivery.
This service is intended for healthcare professionals, sponsors and institutional partners. All supply is subject to applicable regulatory, clinical, institutional and import requirements.
Seamless, compliant access pathways for unapproved medicines across the region
In Australia, Managed Access Programs must operate within applicable TGA pathways, including the Special Access Scheme and Authorised Prescriber pathway, together with hospital medicines access procedures and pharmacy governance requirements.
HL Pharma helps sponsors navigate these operational interfaces by maintaining clear documentation, stock traceability, audit-ready records and visibility across each stage of supply. This supports consistent program delivery while helping sponsors retain control over governance, inventory and costs.
Your GDP logistics and controlled-medicines partner in Australia and New Zealand
HL Pharma provides validated temperature-controlled storage across ambient, refrigerated, frozen and ultra-low temperature ranges, supported by continuous monitoring, deviation management and batch and expiry control.
Our secure, access-controlled facilities support medicines across Schedules 2 to 9, including narcotic and psychotropic medicines, subject to applicable licences and approvals. We coordinate national and international distribution to hospitals, specialist clinics and pharmacies using chain-of-custody controls, integrated data loggers and audit-ready movement records.
Integrated reverse logistics support the return, reconciliation and approved destruction of unused or expired stock, maintaining full accountability throughout the product lifecycle.
Why partner with HL Pharma?
With Asia-Pacific coverage, Importer-of-Record expertise, controlled-medicines capability and alignment with Managed Access Program governance requirements, HL Pharma supports global sponsors in planning and delivering programs across the region.
We also support post-clinical trial supply and continuity of treatment following the conclusion of a clinical study, where an appropriate managed access or early-access pathway is available.
Have questions about Managed Access Programs, Importer-of-Record requirements or controlled medicines? Visit our FAQs or speak with HL Pharma’s Managed Access team.