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Frequently Asked Questions

Your questions, answered.

We’ve gathered answers to the most common questions we receive from sponsors, CROs, manufacturers, and distributors seeking a pharmaceutical depot in Australia and across the Asia Pacific region.

These FAQs cover how HL Pharma acts as an APAC depot and Importer of Record, how our ISO 9001:2015, GDP/GWP-aligned quality framework works, and how we support clinical trials, Managed Access and compassionate supply with secure, temperature-controlled storage and distribution. If you still have questions, please get in touch, and we can talk through your project.

  • Does HL Pharma support international sponsors as an Importer of Record?

    Yes. HL Pharma provides overseas sponsors with an established operating base in Australia and, subject to the product and project requirements, can act as Importer of Record for imports into Australia.

  • Do you operate as an APAC clinical and commercial depot and Importer of Record?

    Yes. From our Melbourne facility, HL Pharma operates as an Australia-based APAC clinical and commercial depot, providing GDP-aligned 3PL and 4PL pharmaceutical storage and distribution.

    Where appropriate and agreed, HL Pharma can also act as the Australian sponsor and Importer of Record for clinical, early-access and complex commercial supply into Australia.

  • Can HL Pharma provide storage and 3PL solutions for overseas distributors targeting the APAC region?

    Yes. HL Pharma provides GDP-aligned pharmaceutical storage and 3PL/4PL solutions for overseas distributors supplying Australia and the wider Asia Pacific region.

    Our licensed Melbourne facility provides validated temperature-controlled storage, including Schedule 8 and Schedule 9 capability, subject to applicable licences and approvals. We support a range of products, including controlled medicines, medical devices, cosmetics and veterinary products.

    HL Pharma can operate as an Australian supply hub, providing inventory management, order fulfilment and distribution to hospitals, pharmacies and approved sites while aligning with the client’s broader regional logistics strategy.

  • Can HL Pharma support clinical trials, Managed Access and Early-Access programs and post‑trial supply?

    Yes. HL Pharma supports clinical trials, Managed Access, Early Access Programs and post‑trial continuity of supply.

    Our services can include Australian regulatory sponsorship and Importer-of-Record responsibilities, regulatory coordination, temperature-controlled storage, inventory management and distribution for approved and unapproved medicines.

    Services are tailored to the applicable TGA pathway, state and territory requirements, institutional procedures and sponsor responsibilities, with distribution available across Australia, New Zealand and the wider Asia-Pacific region.

  • Is HL Pharma a GMP manufacturing site?

    No. HL Pharma is not a GMP-licensed manufacturing site and does not undertake GMP-licensed manufacturing, repackaging or secondary packaging activities.

    HL Pharma operates as a pharmaceutical wholesaler, depot and logistics partner, focusing on global sourcing of medicines, Australian regulatory sponsorship where appropriate, temperature-controlled storage, compliant distribution and continuity of patient access.

  • How does HL Pharma work alongside our CRO, CMO or global logistics providers?

    HL Pharma can act as a specialist local depot while working alongside your existing CRO, CMO, central packaging provider, logistics provider or internal team.

    Under the agreed allocation of responsibilities, your existing partners can retain oversight of the protocol, timelines and broader program, while HL Pharma manages the relevant Australian functions. These may include importation, temperature-controlled storage, order preparation, distribution, returns and inventory reconciliation.

    We can work with sponsor-nominated couriers and service providers or use our qualified transport partners. This allows clients to retain their global vendor arrangements while using HL Pharma as an Australia-based APAC depot for clinical trial products, Managed Access Programs, early-access supply, medicine shortages and commercial inventory.

  • How does HL Pharma support TGA registration and act as the Australian sponsor, or do we need a separate partner?

    HL Pharma provides regulatory and registration services for companies entering or expanding in the Australian market.

    Support may include TGA submissions, ARTG registrations and listings, quality and safety documentation, and pharmacovigilance and post-market reporting through appropriately qualified specialist partners.

    Where appropriate, HL Pharma can act as the Australian sponsor, managing day-to-day TGA liaison, regulatory maintenance and agreed local safety responsibilities. Clients retain ownership of their product, intellectual property and broader global commercial strategy.

    This allows international manufacturers and distributors to combine Australian regulatory sponsorship, depot services and temperature-controlled logistics through one accountable local partner.

  • How does HL Pharma manage secure clinical trial and Managed Access storage and distribution across Australia and APAC?

    Clinical trial and Managed Access stock can be held within validated temperature-controlled environments at HL Pharma’s Melbourne facility. Available conditions include ambient, controlled room temperature, refrigerated, frozen and ultra-low temperature storage.

    Relevant storage zones are temperature-mapped, continuously monitored and alarmed, with controlled access, product segregation and clearly defined quarantine and release status.

    HL Pharma distributes products to approved hospitals, pharmacies, clinics and study sites across Australia, New Zealand and the wider Asia-Pacific region using suitable packaging systems and qualified freight partners.

    Product movements are documented to maintain chain of custody and traceability for blinded and unblinded stock, returns, destruction and retention samples. Activities are managed through HL Pharma’s ISO 9001:2015-certified, GDP/GWP-aligned electronic quality management system.

  • Does HL Pharma provide standalone pharmacovigilance services?

    No. HL Pharma does not provide pharmacovigilance as a separate standalone outsourced service.

    Where pharmacovigilance or regulatory safety support forms part of a broader HL Pharma engagement, we can coordinate support through trusted specialist partners. This may apply where HL Pharma is engaged for local sponsorship, Managed Access, Early Access, Post-Clinical Trial Supply, storage, distribution or related Australian supply activities.

  • What should sponsors look for in a Managed Access Program (MAP) partner, and how does HL Pharma support these programs?

    Sponsors should choose a MAP partner with demonstrated experience navigating Australia’s regulatory, clinical and pharmaceutical supply requirements, particularly for unapproved and early-access medicines, together with a professional understanding of medicines and their handling requirements.

    The partner should have detailed knowledge of relevant TGA pathways, including the Special Access Scheme and Authorised Prescriber pathway and, where applicable, Section 19A arrangements for medicines supplied during a shortage.

    They should also hold the appropriate licences for scheduled and controlled medicines, operate an ISO 9001:2015-certified quality management system aligned with GDP and GWP principles, provide validated temperature-controlled storage for controlled medicines, including Schedules 8 and 9, and maintain clear documentation and audit trails from the initial request through to program close-out.

    HL Pharma brings these capabilities together by coordinating importation, controlled storage, inventory management and distribution to approved sites across Australia and New Zealand, subject to the applicable regulatory, clinical and institutional requirements.

  • Which quality standards does HL Pharma operate under, and how does ISO 9001:2015 certification benefit clients?

    HL Pharma operates an ISO 9001:2015-certified electronic quality management system supporting pharmaceutical storage, distribution, and 3PL/4PL services.

    Our procedures are aligned with PIC/S Good Distribution Practice principles and the Australian Code of Good Wholesaling Practice for medicines in Schedules 2, 3, 4 and 8.  Schedule 9 products are managed under applicable Victorian licences, approvals and additional security controls.

    The quality system manages standard operating procedures, staff training, deviations, corrective and preventive actions, change control, document management and audits. Traceable electronic records and signatures provide a clear evidence trail for client audits, regulatory inspections and internal quality reviews.

    ISO 9001:2015 certification provides independent assessment of the quality management system against the requirements of the ISO standard. GDP and GWP alignment is supported through HL Pharma’s procedures, operational controls and quality oversight.

    For more details, see our Quality, Regulatory and Governance Framework.

  • What is the difference between Good Distribution Practice (GDP) and Good Wholesaling Practice (GWP), and how does HL Pharma apply them?

    Good Distribution Practice provides internationally recognised principles for maintaining the quality and integrity of medicines throughout storage, handling and distribution.

    Unlike the European Union, Australia does not operate a national, regulator-issued GDP certification or GDP-based Wholesale Distribution Authorisation scheme for medicine wholesalers. Pharmaceutical wholesaling is regulated principally through state and territory legislation and licensing arrangements.

    The Australian Code of Good Wholesaling Practice applies to medicines in Schedules 2, 3, 4 and 8 and is given effect through applicable state and territory legislation and wholesaler licensing arrangements.

    HL Pharma aligns its relevant procedures with PIC/S GDP principles and the Australian GWP Code and incorporates these controls within its ISO 9001:2015-certified electronic quality management system.

    This supports product integrity, data integrity, traceability and audit readiness and helps ensure that controlled and temperature-sensitive medicines are handled consistently from receipt through to final delivery.

  • What controlled medicine licences and permits does HL Pharma hold?

    HL Pharma holds relevant Victorian Department of Health licences for the storage and handling of medicines in Schedules 2, 3, 4, 8 and 9 at its Melbourne facility.

    Controlled products are stored in secure, access-controlled areas, including appropriate vault and safe infrastructure, with restricted access, CCTV monitoring and reconciled inventory records.

    HL Pharma also holds an Office of Drug Control import and export licence for applicable narcotic and psychotropic substances and coordinates the shipment-specific permits required for their import or export.

    Domestic storage, handling and distribution are managed in accordance with applicable Commonwealth, state and territory requirements.

  • How does HL Pharma support access to unapproved medicines or overseas-registered medicines, including shortages and compassionate or early access?

    HL Pharma assists hospitals, clinics, sponsors and distributors with sourcing unapproved or overseas-approved medicines where there is a shortage, a recall or no suitable alternative included on the Australian Register of Therapeutic Goods.

    We support supply through the applicable regulatory mechanism. This may include Section 19A for medicines supplied during an Australian shortage, the Special Access Scheme for individual patients, or the Authorised Prescriber pathway for classes of patients.

    HL Pharma also supports sponsor-led Managed Access Programs, compassionate supply and other early-access arrangements.

    Once the appropriate regulatory pathway is confirmed, HL Pharma can coordinate importation, secure temperature-controlled storage, inventory management and distribution to approved sites.

    Responsibility for clinical decisions and regulatory applications remains with the relevant prescriber, sponsor or authorised applicant, depending on the pathway. HL Pharma manages the agreed import, handling and logistics activities within its quality management system.

  • What temperature ranges and storage conditions are available at HL Pharma’s Melbourne facility?

    HL Pharma’s purpose-built Melbourne facility provides validated storage across multiple temperature ranges, including controlled room temperature from 15°C to 25°C, refrigerated storage from 2°C to 8°C, frozen storage and ultra-low temperature storage.

    Ambient storage is also available for products that do not require active temperature control.

    Relevant storage zones are temperature-mapped, continuously monitored and alarmed, with backup power and documented deviation-management procedures.

    Controlled access, product segregation and clear inventory status, including quarantine and released stock, help ensure that clinical, early-access and commercial products are maintained under their required storage conditions.

  • How does HL Pharma manage temperature excursions and other storage deviations?

    HL Pharma’s storage areas are continuously monitored and alarmed, with documented procedures for investigating temperature excursions and other deviations.

    Affected stock is identified and assigned the appropriate inventory status while the event is assessed, documented and communicated in accordance with the agreed quality arrangements. Product disposition remains subject to the relevant sponsor or authorised quality decision.

  • Can HL Pharma store odour-sensitive products?

    Yes, subject to an assessment of the product, formulation and packaging requirements.

    HL Pharma can apply appropriate controls, which may include physical segregation, secondary containment and defined inventory status management, to minimise the risk of odour or volatile transfer between products.

    These controls are documented and managed through our ISO 9001:2015-certified, GDP/GWP-aligned electronic quality management system to support traceability and audit readiness.

  • Can HL Pharma manage retention samples and contingency stock for global studies?

    Yes. HL Pharma stores retention samples and contingency stock alongside active inventory at our Melbourne depot.

    Products are held under the applicable validated storage conditions, with appropriate segregation, status labelling, and full batch, expiry and location traceability.

    Maintaining reference and contingency stock in Australia can support investigations, stability testing, recalls and regulatory inspections while helping to minimise disruption to ongoing clinical or commercial supply across Australia, New Zealand and the wider Asia-Pacific region.

  • Can HL Pharma manage returns, recalls, stock reconciliation and destruction?

    Yes. HL Pharma can coordinate product returns, quarantine, inventory reconciliation, recall support and approved destruction under documented procedures and client instructions.

    Stock movements and final disposition are recorded to maintain traceability and support sponsor, hospital and regulatory audit requirements.

  • How does HL Pharma give remote QA and operations teams visibility of stock and temperature data?

    HL Pharma provides authorised users with access to a secure client portal connected to its warehouse management system.

    Clients can view current inventory, batch and expiry details, stock locations and order status for products held at HL Pharma’s Melbourne facility.

    Temperature records, deviation information and relevant quality documentation are maintained within HL Pharma’s monitoring and quality systems and can be provided in accordance with the agreed service arrangements.

    This gives remote quality, supply-chain and operations teams the visibility required to monitor inventory, support release decisions, assess deviations, prepare for audits and manage study or program close-out activities.

  • Can authorised client users raise purchase and sales orders through HL Pharma’s portal?

    Yes. Authorised client users can raise purchase and sales orders directly through HL Pharma’s secure client portal.

    This supports more efficient management of inbound inventory and outbound distribution, while giving operations teams clearer visibility of order status, stock movements and fulfilment activity.

    Access permissions are controlled according to the agreed service arrangements and user responsibilities.

  • What types of products can HL Pharma hold as an APAC depot?

    HL Pharma can store approved and unapproved medicines, investigational products, medical devices, biologics, vaccines, high-value speciality products and selected cosmetic and veterinary products, subject to applicable licences, product assessment and service agreements.

    HL Pharma holds Victorian Department of Health licences covering medicines in Schedules 2, 3, 4 and 8 and relevant Schedule 9 substances. It also holds an Office of Drug Control licence for the import and export of applicable controlled substances.

    Validated controlled room temperature, refrigerated, frozen and ultra-low temperature storage enables HL Pharma to support a broad range of products used in clinical trials, Managed Access Programs, compassionate supply and commercial distribution.

  • Which organisations typically use HL Pharma, and where do you operate?

    HL Pharma supports Australian and international pharmaceutical and biotechnology companies, CROs, CMOs, medical device manufacturers, hospital research units, wholesalers and specialist distributors requiring licensed pharmaceutical storage and distribution in Australia.

    Clients are located across Europe, North America, Asia, the Middle East, Australia and New Zealand and use HL Pharma as an Australia-based APAC depot for clinical, early-access and commercial products, including controlled and temperature-sensitive medicines.

    HL Pharma operates from a purpose-built, temperature-controlled facility in Keysborough, Victoria, supporting projects across every Australian state and territory, New Zealand and the wider Asia-Pacific region.

    From this facility, HL Pharma provides Australian importation, storage, inventory management and temperature-controlled distribution through an ISO 9001:2015-certified, GDP/GWP-aligned quality management system.

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