Beyond Sourcing: Supporting the Complete Pharmaceutical Access and Supply Pathway in Australia

Sourcing a medicine internationally is only the first part of Australian market access. For an international pharmaceutical or biotechnology company, finding a medicine and finding a way to supply it in Australia are two different problems. The first is a sourcing exercise. The second involves regulatory pathways, import compliance, specialist storage, hospital procurement processes and a defined allocation of responsibility across every party involved. Companies that treat pharmaceutical supply into Australia as a single transaction — locate the product, ship it, done — often discover the gap only once a hospital order is already on the table and the product cannot yet reach the patient.

This is the distinction ProPG works within. We are not a freight company, a courier, or a warehouse operator that happens to handle pharmaceuticals. We are a pharmaceutical access and supply partner, and storage and logistics are components of that broader, regulated function — not the function itself.

Why sourcing a medicine is only the beginning

Locating and procuring a medicine internationally demonstrates that a product exists and a supplier can deliver it. It does not establish that the product can lawfully enter Australia, that a hospital can order it through normal procurement channels, or that it can be stored, tracked and dispensed to satisfy both the supplying company's obligations and the receiving institution's expectations.

Between sourcing and patient access sits a sequence of steps that each carry their own compliance requirements: import documentation, an appropriate access pathway, GDP-aligned storage, inventory control, and clear allocation of who is responsible for what once the product is in the country. Solving sourcing does not, on its own, solve any of these steps.

The operational problems companies face when supplying into Australia

International sponsors and CROs new to the Australian market typically encounter the same friction points: uncertainty about which access pathway applies; import processes that differ from their home jurisdiction; no established hospital pharmacy or procurement relationships; and no local infrastructure for temperature-controlled storage once product lands.

None of these problems is insurmountable on its own. Left uncoordinated, together they slow supply and increase compliance risk, and can leave a hospital pharmacist waiting on a product that technically exists somewhere in the chain but is not yet accessible to them.

Potential support with SAS, Section 19A and other access pathways

Unapproved or unlicensed medicines reach Australian patients through defined regulatory mechanisms — the Special Access Scheme (SAS) and Section 19A approvals among them. Each pathway has its own eligibility criteria, sponsor obligations and evidentiary requirements, and the right pathway depends on the specific product, indication and supply scenario.

ProPG supports pharmaceutical companies in navigating SAS and Section 19A supply and other relevant access routes for unlicensed medicines in Australia, working alongside the company's own regulatory function to help identify which pathway fits a given circumstance and what a compliant supply arrangement looks like in practice. Regulatory, sponsor and pharmacovigilance responsibilities are defined according to the access pathway and agreed operating model; our role is to support that process with Australian market experience, within whatever responsibilities have been formally agreed.

Import coordination and pharmaceutical supply-chain management

Getting a regulated medicine from an overseas manufacturing or distribution site into Australia involves import documentation, customs and biosecurity requirements, and coordination between the originating supplier, the local sponsor and the eventual point of use. ProPG coordinates this import process as part of a broader pharmaceutical logistics capability in Australia, managing the handoffs between international supply and Australian receipt so product movement stays aligned with the access pathway under which it is being supplied.

Specialist ambient and cold-chain storage through qualified logistics infrastructure

Many of the medicines moving through unlicensed and shortage-supply channels — biologics, specialty injectables, temperature-sensitive comparators — require validated ambient or cold-chain conditions from import through to dispensing. ProPG coordinates qualified ambient and cold-chain storage through established pharmaceutical logistics partners, so cold-chain pharmaceutical distribution is monitored and managed to the standards these products require.

This storage capability exists to support the regulated supply function described above, not as a standalone warehousing service. The value lies in storage integrated with the access pathway and the eventual hospital order, not in square metres of shelving.

Inventory oversight and distribution to hospitals and healthcare providers

Once product is stored, it still needs to move to the right hospital, in the right quantity, at the right time, with traceability maintained throughout. ProPG provides inventory oversight and manages distribution into Australian hospital distribution channels, giving sponsors visibility over stock position and movement rather than a black box between import and delivery.

Allocating responsibility clearly across the supply chain

A multi-party pharmaceutical supply arrangement only works when everyone understands who is responsible for what. Sponsor obligations, pharmacovigilance, medical information handling, quality oversight, recall procedures and product liability all need explicit allocation between the international manufacturer, the local sponsor or supply partner, and any other party in the chain. Ambiguity here is a genuine risk, not a formality to resolve later.

Regulatory, sponsor and pharmacovigilance responsibilities are defined according to the access pathway and agreed operating model — they do not sit in the same place for every arrangement. ProPG works through this allocation with each client when establishing a supply arrangement, so responsibilities are documented and agreed before product moves, rather than assumed. Where a company is establishing a Managed Access Program, ProPG's role may range from supply-chain support to broader coordination — regulatory submissions, import, storage, distribution — subject to regulatory review and formal agreement between the parties.

Direct hospital accounts: an execution advantage

A regulatory pathway and a compliant supply chain still need to end somewhere — typically an Australian hospital pharmacy department. ProPG has established direct supply accounts with hospitals across Australia, built through ongoing supply of unlicensed medicines and shortage-related products. These relationships mean product can move through familiar procurement channels rather than requiring a new relationship built from nothing for every product and every hospital.

This is an operational advantage, not a guarantee. Established accounts reduce friction in reaching the right procurement and pharmacy contacts; they do not determine whether a hospital takes up a given product, which depends on clinical need, formulary decisions and the hospital's own processes. ProPG does not represent access to every Australian hospital — these relationships are a working network built over time, not a fixed distribution list.

International sourcing capabilities: Australian, German and Polish infrastructure

ProPG's ability to support this pathway end-to-end draws on capability across three markets. Our Australian operations connect directly to the access pathways and hospital accounts described above. ProPG's European capabilities are supported by a licensed pharmaceutical logistics partner in Germany operating under EU GDP requirements, together with its Polish affiliate, Jemstar. That same network underpins ProPG's comparator and reference-listed drug (RLD) sourcing for CROs and clinical trial supply, alongside unlicensed medicine and shortage supply into Australia.

Together, this capability lets ProPG source from a broad supplier base and coordinate product movement from international origin through to Australian storage and hospital delivery, rather than handing a client between disconnected vendors at each stage.

A flexible model, not an all-or-nothing one

Not every client needs the same scope of support. Some engage ProPG purely for sourcing or import coordination. Others ask us to manage storage and distribution once product has already cleared its access pathway. Others engage ProPG to coordinate the fuller pathway — sourcing, access pathway support, import, storage and hospital distribution — under a single point of coordination, with the option to add further elements as requirements become clearer.

Working with ProPG

Pharmaceutical supply into Australia is rarely a single problem with a single solution. It is a sequence of regulatory, logistical and relationship-based steps that each need to be managed correctly for a product to reach the patients who need it. ProPG's role is to help pharmaceutical companies navigate that sequence, drawing on established infrastructure and hospital relationships built over time.

If your organisation is assessing how to bring a product into the Australian market, or looking to strengthen an existing supply arrangement, contact ProPG to discuss which elements of the pathway we can support.