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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?

    HL Pharma gives overseas sponsors a ready-made base in Australia. For many projects, we can act as Importer of Record into Australia.

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

    Yes. HL Pharma operates a Melbourne‑based APAC clinical and commercial depot, providing GDP-aligned 3PL and 4PL pharmaceutical storage and distribution, and serves as the TGA Sponsor and Importer of Record for clinical, early-access, and complex commercial programs 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 seeking to supply Australia and the wider Asia Pacific region. Our Melbourne facility offers licensed, temperature-controlled warehousing, including Schedule 8 and 9 capability, with quality systems aligned to Good Distribution Practice and Good Wholesaling Practice.

    We store and distribute products for international companies, including controlled medicines, cosmetic and medical products, supporting both routine commercial distribution and specialist Managed Access or early-access programs.  HL Pharma can serve as an Australian hub, providing local inventory management, order fulfilment, and hospital or pharmacy supply in accordance with Australian regulatory requirements, while aligning with your 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 supply as TGA Sponsor and Importer of Record, providing GDP‑aligned storage, distribution and regulatory management for unregistered and registered medicines across APAC

  • Is HL Pharma a GMP manufacturing site?

    No. HL Pharma is not a GMP-compliant manufacturing site and does not perform any GMP‑licensed manufacturing or secondary-packaging activities.

    HL Pharma operates as a GDP/GWP-aligned pharmaceutical wholesaler and logistics partner, focusing on global medicine sourcing, TGA regulatory sponsorship, temperature‑controlled storage, compliant distribution, and ongoing patient access across Australia and the wider region.

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

    HL Pharma can serve as your specialist depot and work with your existing partners. Your CRO, CMO or in-house team stays in control of the protocol, timelines and overall program. We handle the on-the-ground steps in Australia and New Zealand, covering importation, temperature-controlled storage, order preparation, distribution, and returns from our licensed Melbourne facility.

    For most projects, we follow sponsor-approved instructions and coordinate with your CRO, central packaging or labelling provider and chosen couriers, or we can use our qualified and verified transport partners. This allows you to retain your global vendors while using HL Pharma as a licensed APAC depot for clinical trial medicines, Managed Access and Early Access programs, shortages, and commercial stock.

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

    We provide regulatory and registration services for companies entering or expanding in the Australian market, including support for TGA submissions, ARTG listings, quality and safety documentation, and pharmacovigilance and post-market reporting through specialist partners.

    Where appropriate, HL Pharma can act as the sponsor in Australia, handling day-to-day TGA liaison, licence maintenance, and local safety obligations. At the same time, you retain global ownership of the product. This allows overseas manufacturers and distributors to combine regulatory sponsorship, APAC depot services, and temperature-controlled 3PL/4PL logistics with a single partner, rather than juggling multiple local providers.

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

    Clinical trial and Managed Access stock can be held in validated temperature-controlled environments at our Melbourne depot, including controlled room temperature (Ambient), refrigerated, frozen and ultra-low storage. Each zone is temperature-mapped, continuously monitored and alarmed, with controlled access, product segregation, and clear quarantine and release status.

    From there, we ship to approved sites across Australia, New Zealand, and the wider Asia Pacific region, using validated packaging and working with qualified freight partners. Every movement is recorded, ensuring a transparent chain of custody for blinded and unblinded stock, returns, destruction, and retention samples. All activity is conducted within an ISO 9001:2015-certified, GDP/GWP-aligned electronic quality management system, providing sponsors and CROs with an audit-ready depot for clinical, Managed Access, Early Access, and post-trial supply.

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

    It is recommended that Sponsors choose a MAP partner who understands the Australian landscape, particularly in unregistered and early-access medicines, and has experience working in this area with a professional understanding of medicines.  They should also have detailed knowledge of TGA pathways, including Section 19A, the Special Access Scheme (SAS), and the Authorised Prescriber.  The partner should hold licences for standard and controlled medicines, operate an ISO 9001:2015-certified quality system aligned with GDP and GWP, provide temperature-controlled storage capable of supporting Schedules 8 and 9, and maintain clear documentation and audit trails from the first request through to program close-out.

    HL Pharma supports Managed Access and compassionate supply programs by arranging compliant import where needed, providing temperature-controlled storage, handling controlled medicines and distributing to approved sites across Australia and New Zealand. All activities are overseen by our pharmacists and underpinned by our ISO 9001:2015-certified, GDP/GWP-aligned electronic quality management system with electronic records, reconciliation, and clear roles for the sponsor, prescriber, and depot, helping protect patients, sponsors, and treating hospitals while maintaining a defensible governance and audit framework.

  • 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 covering pharmaceutical storage, distribution, and 3PL/4PL services. Our procedures follow PIC/S Good Distribution Practice and the Australian Code of Good Wholesaling Practice for medicines in Schedules 2, 3, 4, 8, and 9, from receipt and quarantine through to storage, order preparation, dispatch, returns, and destruction.

    The system controls SOPs, training, deviations, CAPAs, change control, document management and audits, with traceable records and electronic signatures that are consistent with 21 CFR Part 11 and EU Annex 11 requirements. For clients, this means HL Pharma works to a documented, independently assessed framework that reduces the risk of handling errors or temperature excursions and provides a clear evidence trail for audits, inspections, and internal QA reviews.

    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?

    Unlike the EU, Good Distribution Practice is not a formally licensed standard in Australia. In Australia, the Therapeutic Goods Administration expects wholesalers of medicines in Schedules 2, 3, 4, and 8 (and some Schedule 9) to follow the Code of Good Wholesaling Practice, which applies GDP principles to storage and distribution.

    At HL Pharma, we design our procedures in accordance with both PIC/S GDP guidance and the Australian GWP Code, and embed them within our ISO 9001:2015-certified electronic Quality Management System. The system controls SOPs, training and competency, deviations and CAPA, change control, document management and audits, with traceable records and electronic signatures consistent with 21 CFR Part 11 and EU Annex 11. This supports data integrity, traceability and audit readiness, and helps ensure controlled and temperature-sensitive medicines are handled consistently and compliantly from receipt through to final delivery.

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

    HL Pharma holds Victorian Department of Health licences for the storage and handling of medicines in Schedules 2, 3, 4, 8 and 9 at our Melbourne facility. Controlled products are kept in secure, access-controlled areas with vaults and safes, restricted access, CCTV monitoring and reconciled stock records.

    We also hold an Office of Drug Control import and export licence for narcotic and psychotropic substances and coordinate the permits required for the import, export, and distribution of controlled medicines used in clinical trials, Managed Access, and commercial supply. This allows sponsors and CROs to centralise controlled drug management at a specialist depot rather than building their own controlled infrastructure in Australia.

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

    HL Pharma assists hospitals, clinics, sponsors and distributors in sourcing unregistered or overseas-registered medicines when there is a shortage, a recall or no suitable option on the Australian Register of Therapeutic Goods. We work within Therapeutic Goods Administration frameworks, including Section 19A, the Special Access Scheme, Authorised Prescriber pathways, Managed Access programs and other compassionate or early access arrangements.

    Once the appropriate regulatory route is in place, we manage compliant import, secure temperature-controlled storage, inventory management and distribution to approved sites from our licensed Melbourne facility. Prescribers and Sponsors remain responsible for clinical decisions and regulatory submissions. At the same time, HL Pharma manages the practical import, handling, and logistics under an ISO 9001:2015-certified, GDP/GWP-aligned quality management system.

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

    Our purpose-built Melbourne facility provides validated storage across multiple temperature ranges, including controlled room temperature (+15 °C to +25 °C), refrigerated (+2 °C to +8 °C), frozen (−20 °C), and ultra-low (−80 °C). We also offer secure ambient storage for products that do not require active temperature control.

    All zones are temperature-mapped, continuously monitored and alarmed, with backup power and documented deviation management. Controlled access, segregation, and clear status labelling, such as quarantine and released stock, help ensure that clinical, early access, and commercial products are held under appropriate conditions and remain inspection-ready for sponsors, CROs, manufacturers, and healthcare providers.

  • Can you store odour-sensitive products and prevent odour or volatile transfer (cross-contamination) from other products in your facility?

    Yes. We review your product and packaging requirements and apply appropriate segregation and inventory status management (including quarantine and release) within our licensed Melbourne facility. This is managed within our ISO 9001:2015-certified, GDP/GWP-aligned eQMS to support traceability and audit-ready records. If your product is odour-sensitive or at risk of odour or volatile transfer, we can minimise that risk through suitable segregation and containment.

  • 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. Batches are held in the same validated temperature ranges as released stock, with clear segregation, status labelling and full batch and location traceability.

    Keeping reference stock in Australia enables sponsors and CROs to support investigations, stability checks, recalls, and regulatory inspections without interrupting ongoing clinical or commercial supply across Australia, New Zealand, and the wider Asia Pacific region.

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

    HL Pharma provides a secure client portal that links to our warehouse and quality systems. Approved users can see real-time inventory, batch and expiry details, storage locations and order status for stock held in Australia, without needing to request ad hoc reports.

    Temperature data, deviations, and audit history are recorded in our ISO 9001:2015-certified electronic quality management system and are available on request. This provides QA, supply chain, and operations teams with sufficient detail to support release decisions, deviation assessments, audits, and study close-outs, whether they are based in Australia or overseas.

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

    HL Pharma can store licensed and unlicensed medicines, investigational products, medical devices, biologics, vaccines, high-value speciality products and selected cosmetic and veterinary items, subject to appropriate licences and agreements.

    We hold Victorian Department of Health licences for Schedules 2, 3, 4, 8, and 9 medicines, and an Office of Drug Control licence for the import and export of controlled substances, alongside validated ambient, refrigerated, frozen, and ultra-low-temperature storage. This combination enables HL Pharma to serve as a single, secure depot for most product types used in clinical trials, Managed Access programs, compassionate supply, and commercial distribution across Australia, New Zealand, and the wider Asia Pacific region.

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

    HL Pharma supports Australian and international pharmaceutical and biotech companies, CROs, CMOs, medical device manufacturers, hospital research units, wholesalers and specialist distributors that need licensed pharmaceutical storage and distribution in Australia. Many are based in Europe, North America, Asia or the Middle East and use HL Pharma as a neutral APAC depot for clinical, early access and commercial medicines, including controlled and temperature-sensitive products.

    We operate from a purpose-built, temperature-controlled facility in Keysborough, Victoria, and support projects across all Australian states and territories, New Zealand, and the wider Asia Pacific region. From this site, we provide import, storage, and temperature-controlled distribution under an ISO 9001:2015-certified, GDP/GWP-aligned quality management system.

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