Medicine Shortages in Australia: What Access Pathways Are Available?
- 4 days ago
- 9 min read
When a hospital pharmacist can't get a medicine onto the ward, the immediate questions are what alternatives or access pathways may be available, who needs to act, and how quickly supply can realistically be established. This guide sets out the main options available when a medicine is unavailable or in shortage in Australia, using current Therapeutic Goods Administration (TGA) and Pharmaceutical Benefits Scheme (PBS) guidance as the reference point throughout.
It is general information, not legal or clinical advice. Every shortage has its own facts, and the TGA's own guidance should always be checked before a decision is made for a specific patient, product or hospital.
1. What happens when a medicine becomes unavailable in Australia?
Not every "we can't get it" is the same problem. A TGA-listed shortage or discontinuation is a nationally reported supply problem: the sponsor of an ARTG-registered medicine has told the TGA that supply is disrupted, reduced or ending, recorded through the TGA's medicine shortages reporting system. A local supply problem is different — the medicine remains registered and available nationally, but a particular hospital or pharmacy can't get stock through its usual channel, perhaps due to a distribution issue or a temporary backorder.
Either way, the first practical step is to establish the actual supply position rather than assume the worst: check whether the shortage is formally reported to the TGA, contact the product's sponsor directly, and check whether a registered alternative already exists — a different brand or generic of the same active ingredient, strength and form, separately approved for supply in Australia. If one is available, that is generally the simplest path, and none of the pathways below are needed. Background on how ProPG supports hospitals through this process is on our Medicine Shortages page.
2. The main access pathways
Once it's clear no straightforward registered alternative is available, several access pathways may apply, depending on the situation. The table below is a general orientation, not regulatory or clinical advice.
Pathway | What it is | Patient-specific or broader? | Who is typically involved | When it may be relevant |
Australian registered alternative | A different ARTG-registered brand or generic of the same active ingredient, strength and form | Broader — normal supply channels | Hospital pharmacy, wholesaler, alternative sponsor | Whenever a suitable registered product exists; usually checked first |
Section 19A | TGA approval to import and supply an overseas-registered medicine in place of a registered medicine that is unavailable or in shortage | Broader — a supply-chain approval, not tied to one patient | Approval holder (often a wholesaler or sponsor), TGA, ordering hospital | National shortage or discontinuation of a registered medicine, with a sourceable overseas equivalent |
SAS Category A | Notification-only access for a seriously ill patient, lodged after supply | Patient-specific | Treating practitioner, TGA (notified, not asked to pre-approve) | Death reasonably likely within months, or premature death likely without early treatment |
SAS Category B | Application-based access requiring TGA Delegate approval before supply | Patient-specific | Treating practitioner, TGA Delegate, sponsor/supplier | Patient doesn't meet Category A criteria and the product isn't on the Category C list |
SAS Category C | Notification-only access limited to goods on a TGA-published list with an established history of use | Patient-specific | Authorised health practitioner, TGA (notified, not asked to pre-approve) | The specific product and indication appear on the current Category C list |
Authorised Prescriber | Standing TGA authorisation for a practitioner to supply a specified unapproved good to a defined class of patients | Broader within scope — a class of patients, not one application per patient | Authorised practitioner, specialist college or HREC, TGA | A practitioner regularly treats a defined patient group with the same condition and product |
This table is a general comparison only. For the detailed distinction between Section 19A and the Special Access Scheme, see ProPG's dedicated article, Section 19A vs Special Access Scheme (SAS): What's the Difference in Australia?
3. Section 19A during a medicine shortage
Section 19A of the Therapeutic Goods Act 1989 allows the import and supply of a medicine not on the Australian Register of Therapeutic Goods (ARTG) — typically registered and manufactured overseas — as a substitute for a registered medicine that has become unavailable, been cancelled or suspended, or gone into shortage. The TGA must be satisfied that supply of the overseas medicine is necessary in the interests of public health before granting approval.
Section 19A works at the supply-chain level rather than the individual-patient level. Per TGA guidance, any person can apply — the applicant doesn't need to already be the ARTG sponsor of the affected medicine. Once approved, the applicant becomes the approval holder and takes on sponsor-equivalent obligations, including pharmacovigilance and supply reporting. In practice this is often a wholesaler or specialist supplier with the relationships needed to source overseas-registered stock. Hospitals and pharmacies then order the approved product through the approval holder's normal channels, the same way they'd order any other stock item — there's no separate application for each patient.
This is what distinguishes Section 19A from the Special Access Scheme. SAS and Authorised Prescriber approvals authorise a specific practitioner to treat a specific patient or class of patients; Section 19A authorises a specific product to be imported and supplied in place of the missing registered medicine. Both can apply to the same shortage, and aren't mutually exclusive — they solve different problems.
A Section 19A approval is also distinct from PBS subsidy. Holding TGA approval to import and supply a medicine doesn't automatically make it PBS-subsidised. Under current PBS guidance, a Section 19A medicine is only treated as a pharmaceutical benefit under the existing listing automatically if its brand, drug, form, manner of administration and responsible person all match the PBS-listed product it replaces. Where any of these differ, the sponsor must submit a separate PBS listing application. The current list is maintained on the PBS Section 19A register.
4. SAS Categories A, B and C
The Special Access Scheme covers access to an unapproved therapeutic good for an individual patient, split into three categories.
Category A applies to a patient who is "seriously ill" in the TGA's defined sense — a condition from which death is reasonably likely within a matter of months, or from which premature death is reasonably likely without early treatment. It is notification-only: the treating practitioner supplies the good and then notifies the TGA, generally within 28 days, rather than waiting for prior approval.
Category B applies where the patient doesn't meet the Category A definition and the product isn't on the Category C list. This requires a full application: the prescriber sets out the clinical justification, and a TGA Delegate must review and approve before the good can be legally supplied. A TGA Delegate must review and approve the application before the product can be supplied under Category B. Processing time can vary, so current TGA guidance should be checked where timing is critical.
Category C is limited to products on a TGA-published list of goods with an established history of use for specified indications. Like Category A, it's notification-only — an authorised practitioner may supply first and notify the TGA afterwards, provided use matches the listed criteria.
All three SAS categories relate to access for individual patients, unlike the broader product-level supply enabled through Section 19A. . Current definitions, the Category C list and the online lodgement system are on the TGA's Special Access Scheme guidance and SAS/AP online system pages.
5. Authorised Prescriber
The Authorised Prescriber scheme sits alongside SAS but solves a different problem. Rather than lodging a fresh SAS request for every patient, a medical or dental practitioner can apply to become an Authorised Prescriber for a specified unapproved good, for a defined medical condition, covering a class of patients under their ongoing care — not just the one patient in front of them that day.
To become an Authorised Prescriber, a practitioner generally needs endorsement from a recognised specialist college or approval from a Human Research Ethics Committee (HREC), unless the good meets "established history of use" criteria that allow this step to be bypassed. Once approved, the practitioner can supply the good to patients meeting the approved criteria without a separate application each time, but takes on ongoing obligations — including six-monthly reports to the TGA and prompt reporting of adverse events.
The practical distinction from SAS Category B is scale: Category B is a one-off approval per patient; Authorised Prescriber is a standing approval per practitioner, per condition, per product, covering multiple future patients. It tends to be relevant where a specialist regularly manages a defined patient group with a shared condition and a consistent treatment need.
6. A practical shortage-access decision sequence
Medicine is reported unavailable or difficult to source through normal channels.
Establish the actual shortage or supply status — check TGA shortage reporting, and contact the sponsor or usual supplier directly.
Consider whether a registered alternative brand, generic or equivalent is available through normal supply channels.
If not, check whether an appropriate Section 19A product is already TGA-approved and available through an approval holder.
If no suitable Section 19A product exists, determine whether an unapproved-goods pathway — SAS Category A, B or C, or Authorised Prescriber — may be relevant to the clinical situation.
Verify current TGA requirements for the specific pathway and product before proceeding, as categories, lists and approval status change.
Source the product through an appropriately licensed supply chain, with the documentation the pathway requires.
This sequence is a general orientation. It does not recommend therapeutic substitution for any specific patient, and does not replace clinical judgement, TGA guidance, or a hospital's own medicines governance processes.
7. The operational layer
Regulatory approval is necessary but it isn't the whole job — this is usually where the gap sits between a pathway looking straightforward on paper and a product arriving on the ward. It's the layer ProPG spends most of its time working in as a licensed pharmaceutical wholesaler.
An approval — Section 19A, SAS or Authorised Prescriber — confirms supply is permitted. It doesn't confirm stock is sitting ready to ship. Overseas availability can shift between approval and order, especially for products already short in their country of origin. Country of origin also affects pack size, labelling and language against what a ward expects, and expiry dating on overseas stock can differ materially from an Australian-registered equivalent.
Lead times matter in their own right: sourcing overseas typically involves supplier confirmation, freight booking, customs clearance and, for temperature-sensitive products, validated cold-chain transport — none of which happens instantly, even once approval is in hand. Controlled drugs bring additional permit and documentation requirements. Depending on the product and pathway, relevant documentation may include batch and supply-chain information, import permits, temperature records and other supporting documentation required for regulatory and hospital quality processes. None of this is a reason to avoid these pathways; it's why experienced sourcing and a licensed, GDP-aware supply chain make the difference between an approval letter and usable stock.
8. ProPG's practical Section 19A experience
Pro Pharmaceuticals Group is an Australian licensed pharmaceutical wholesaler that sources shortage and unlicensed medicines for Australian hospitals, and acts as Section 19A approval holder for a number of products.Rather than describe our own track record in general terms, the TGA's public Section 19A register is the more useful reference: it independently lists Pro Pharmaceuticals Group Pty Ltd as the current approval holder for products including Imipramine HCL tablets, USP 25mg (Leading Pharma, USA) and Praziquantel tablets, USP 600mg (Endo, USA). Approvals change as shortages resolve and are renewed or lapse, so the current and complete list should always be checked directly on the TGA's Section 19A approvals database rather than taken from any single article, including this one.
For examples of specific shortage products ProPG has sourced under Section 19A, see our notices on Imipramine HCL tablets and Praziquantel tablets. General background on how ProPG sources medicines outside standard ARTG registration is on our Unlicensed Medicines page.
9. Frequently asked questions
What should a hospital do when a medicine is unavailable in Australia?
Establish the actual supply position — check whether the shortage is reported to the TGA, contact the sponsor or usual supplier, and check for a registered alternative. If none exists, work through the access pathways above against current TGA guidance.
What is the difference between Section 19A and the Special Access Scheme?
Section 19A authorises import and supply of an overseas medicine into the market in place of a missing registered product, at the supply-chain level. SAS authorises a specific practitioner to treat a specific patient with an unapproved good, at the individual level. See our detailed comparison for the full picture.
What are SAS Categories A, B and C?
Category A covers seriously ill patients and is notification-only. Category B requires a full application and prior TGA Delegate approval. Category C is notification-only access limited to products on a published TGA list with an established history of use.
Can a hospital order a Section 19A medicine directly?
Once approved and stock is available, hospitals and pharmacies may obtain the Section 19A product through the approval holder or its nominated supply arrangements. A separate patient-specific SAS application is generally not required for supply under the Section 19A approval.
Are Section 19A medicines covered by the PBS?
Not automatically. A Section 19A medicine is only subsidised under an existing PBS listing without further review if its brand, drug, form, administration route and responsible person match the product it replaces. Otherwise a separate PBS application is required. Current listings are on the PBS Section 19A page.
What is an Authorised Prescriber?
A medical or dental practitioner who holds a standing TGA authorisation to supply a specified unapproved good to a defined class of patients with a particular condition, rather than applying for SAS access patient by patient.
How long does it take to source a medicine from overseas?
It depends on the product, the approval pathway and current overseas stock availability, and can range from days to weeks even after approval is granted — supplier confirmation, freight, customs clearance and, for temperature-sensitive products, validated cold-chain transport all add time. Confirming current lead times with the approval holder or supplier is the only reliable way to plan around a specific shortage.
Last reviewed: August 2026. This article is general information based on current TGA and PBS guidance at the time of writing. It is not legal, regulatory or clinical advice, and does not recommend any therapeutic substitution for any patient. Regulatory requirements, approval status and product availability change — always verify current requirements directly with the TGA, PBS and the relevant supplier before acting. For help sourcing a specific shortage medicine, contact ProPG.
