Early & Post-Clinical Trial Supply and Access in New Zealand
Supporting access before commercial availability and continuity of treatment after a clinical trial, including early access, trial extensions, rollover arrangements and transition into Managed Access Programmes.
HL Pharma provides coordinated sourcing, supply planning and pharmaceutical logistics support for clinical research, early access and post-clinical trial medicine supply in New Zealand.
From our Melbourne regional depot, we source medicines internationally and coordinate export, temperature-controlled storage and onward supply into New Zealand through appropriately licensed New Zealand import, wholesale and distribution partners.
This gives pharmaceutical and biotechnology sponsors, CROs and healthcare providers one experienced operational partner across the treatment pathway.
For sponsors managing active clinical trials, find out more about our regional clinical depot and clinical supply services.
Permit and Import Support
We coordinate product and shipment documentation, applicable biosecurity import requirements, controlled drug permits and related regulatory paperwork in collaboration with sponsors, regulatory advisers and licensed New Zealand import partners.
Reverse Logistics Solutions
We coordinate the return, reconciliation and destruction of unused investigational medicines and clinical trial materials, with documented traceability supporting study close-out, inventory reconciliation and sponsor audits.
Clinical Trial Retention and Contingency Storage
Our Melbourne regional depot provides secure, temperature-controlled storage for investigational medicines, retention samples and contingency stock following study completion, aligned with sponsor protocols and applicable recordkeeping requirements.
Early and Post-Trial Supply Management
We coordinate international sourcing, regional storage, export and onward supply to support early access, extension studies, rollover arrangements and continued patient treatment after the main clinical trial period.
Supply into New Zealand is undertaken through appropriately licensed New Zealand import, wholesale, pharmacy and distribution partners, according to the applicable regulatory pathway.
New Zealand Access Pathway Coordination
We work alongside sponsors, regulatory advisers, healthcare providers and licensed New Zealand supply partners to support the appropriate pathway for continued medicine access.
Depending on the programme and the medicine involved, this may include continued supply within an approved Section 30 clinical trial or trial extension, Section 29 supply for a named patient, or a sponsor-led Managed Access Programme.
Safety and Reporting Coordination
Where required as part of the broader supply engagement, HL Pharma coordinates safety escalation and regulatory reporting support through trained pharmacists and specialist pharmacovigilance partners, aligned with the sponsor’s global safety framework.
From Clinical Trial to Continued Medicine Access
Continuity of treatment may be maintained within an approved clinical trial or extension, or through a separate early access, named-patient or Managed Access Programme arrangement. Where an investigational medicine continues to be administered within a clinical trial, the relevant Section 30 approval, ethics requirements and study controls continue to apply.
Where treatment transitions outside the clinical trial, a separate supply pathway may be required, including Section 29 supply of an unapproved medicine for a named patient under the care of an eligible New Zealand prescriber. Importation and supply are undertaken through appropriately licensed New Zealand wholesalers or pharmacies, with applicable supply records, reconciliation and Medsafe reporting managed locally. HL Pharma works with sponsors, CROs, healthcare providers, regulatory consultants and New Zealand supply partners to establish a practical transition plan while maintaining product integrity, traceability and continuity of supply.
Regional Depot for New Zealand and Asia-Pacific
HL Pharma’s purpose-built Melbourne facility provides validated temperature-controlled storage and pharmaceutical logistics for investigational, early access and post-clinical trial medicines before export to New Zealand. Acting as a regional depot, we support programmes supplying New Zealand and selected Asia-Pacific markets, including controlled and non-controlled medicines subject to applicable Australian export and New Zealand import licences, permits and regulatory requirements.
Short and long-term storage is available for clinical trials, extensions, rollover arrangements, early access programmes and post-clinical trial supply. Our team works with clinical project managers, research sites, hospital pharmacies and supply partners to keep each supply pathway clear, controlled and manageable.
Facility Features & Quality Systems
Validated Temperature Monitoring
Continuous temperature monitoring across controlled storage environments, supported by real-time alerts, documented escalation procedures and deviation management.
Secure and Fully Alarmed Environment
Restricted-access pharmaceutical storage with surveillance, alarms and monitored entry for high-value, temperature-sensitive and controlled medicines.
Power Backup & Contingency Planning
An on-site backup generator and documented contingency procedures support the maintenance of required storage conditions during a mains power disruption.
Flexible Pharmaceutical Storage
Storage options range from individual cartons to pallets across controlled room temperature, refrigerated and frozen environments to meet the requirements of each programme.
Batch Recall Readiness
Batch, expiry, quarantine and movement traceability through a validated Warehouse Management System, supporting recalls, reconciliation and audit readiness.
Certified Operations
ISO 9001:2015-certified operations aligned with Good Distribution Practice principles and the Australian Good Wholesaling Practice requirements applicable to our Melbourne facility.
Electronic Quality Management System
An ISO 9001:2015-certified electronic Quality Management System provides controlled documentation, version management, audit trails and secure electronic signatures aligned with 21 CFR Part 11 and EU Annex 11 expectations.
Why Choose HL Pharma for Early and Post-Clinical Trial Supply?
HL Pharma brings together international sourcing, regional depot storage and coordinated New Zealand distribution through one experienced partner, supporting sponsors through every stage from trial to continued treatment.
Contact HL Pharma to discuss early access, clinical trial extensions or post-clinical trial medicine supply and distribution in New Zealand and the wider Asia-Pacific region.