Section 19A vs Special Access Scheme (SAS): What's the Difference in Australia?
- 2 days ago
- 6 min read
Hospital pharmacists and procurement teams in Australia regularly face the same question from a different angle: a registered medicine is out of stock, or a clinician needs a treatment that isn't approved here at all. Two Therapeutic Goods Administration (TGA) mechanisms exist to help bridge that gap — Section 19A of the Therapeutic Goods Act 1989 and the Special Access Scheme (SAS). They're often mentioned in the same breath, and for good reason: both can allow supply of a medicine that isn't on the Australian Register of Therapeutic Goods (ARTG). But they are triggered differently, applied for by different people, and suit different circumstances — and which one applies can depend on the specific facts of a situation, so current TGA guidance should always be the final reference point.
Understanding the distinction matters for planning. Reaching for the wrong pathway, or leaving the decision until a shortage is already underway, can add unnecessary delay to getting a patient the treatment they need.
What is Section 19A?
Section 19A of the Therapeutic Goods Act 1989 allows the TGA to approve the import and supply of a medicine that isn't on the ARTG, as a substitute for a registered medicine that is in shortage or being discontinued. It is generally used as a shortage-management tool rather than a patient-by-patient authorisation, though the specific conditions attached to any approval are set by the TGA on a case-by-case basis.
In broad terms, and subject to the conditions the TGA sets for a given approval, per TGA guidance on Section 19A:
Who applies: typically, the sponsor of the substitute medicine (the manufacturer or its Australian representative) applies to the TGA — the hospital or prescriber is not usually the applicant.
What's assessed: the TGA reviews the substitute against the registered product it's replacing, on a case-by-case basis.
What happens once approved: the approval is published on the TGA's public database of Section 19A approvals, and the medicine can generally be ordered and supplied through normal wholesale and hospital pharmacy channels, subject to the terms of that specific approval.
Duration: approval is generally time-limited and tied to the terms the TGA sets for that shortage, which can vary.
A note on naming: the Pharmaceutical Benefits Scheme also has a listing category called "Section 19A" (under the National Health Act 1953), covering certain PBS-subsidised medicines. It is a separate mechanism with a different purpose, and the two are easy to confuse in a search results page. This article is about the Therapeutic Goods Act Section 19A shortage pathway — if you're researching PBS subsidy listings, that's a different question entirely.
What is the Special Access Scheme (SAS)?
The Special Access Scheme is a mechanism that can allow a treating health practitioner to access an unapproved therapeutic good for a specific, named patient under their care. Unlike Section 19A, it isn't limited to shortage situations — depending on the circumstances, it may also cover medicines that have never been registered in Australia, products discontinued without a substitute, or treatments for rare conditions where no ARTG-listed option exists.
The TGA structures SAS into three categories, differentiated broadly by clinical urgency and the strength of existing evidence for the product. Eligibility, notification and approval requirements differ between categories and can change, so it's worth checking the TGA's SAS guidance for health practitioners directly for the current detail on categories and which practitioners can use each one, rather than relying on a secondary source.
Who applies: generally, the treating practitioner, on behalf of an individual patient — though exactly who is eligible to apply, and under which category, depends on the circumstances and should be confirmed against current TGA guidance.
What's authorised: supply to that specific patient, rather than a general market authorisation.
Frequency: in most cases, a fresh application or notification is required per patient, though the exact requirements can vary by category and circumstance.
Section 19A vs SAS: the key differences
The table below summarises the general pattern for each pathway. It's a starting point for orientation, not a substitute for checking eligibility, category and process requirements directly with the TGA for a specific product or situation.
Section 19A | Special Access Scheme | |
|---|---|---|
Trigger | Shortage or discontinuation of a registered medicine | Individual patient need for an unapproved good |
Who applies | Typically the sponsor of the substitute medicine | Generally the treating health practitioner |
Scope of approval | Product-level — can generally cover eligible patients once approved, within the approval's terms | Patient-specific — generally one approval per patient |
Where hospitals fit in | Can generally order the substitute like normal stock, once listed and within approval terms | Typically submit or support an application for each patient |
Visibility | Published on the TGA's S19A database | Not publicly listed (individual patient information) |
When does each pathway apply?
If a registered medicine your hospital normally stocks goes into shortage, a useful first step is checking the TGA's S19A database to see whether a sponsor has already secured approval for a substitute. Where an approval already exists and covers the relevant circumstances, procurement can often source the substitute through normal wholesale channels — generally a lower administrative load than an SAS application for every affected patient.
Where no S19A-approved substitute is available, or the need relates to a specific patient rather than a broader shortage, the Special Access Scheme may be the relevant pathway — but eligibility depends on the category, the practitioner, and the specific product, so this should be confirmed with the treating practitioner and, where needed, directly against current TGA guidance rather than assumed.
For pharmaceutical companies and sponsors, securing Section 19A approval for a substitute during a shortage can reduce the administrative burden on individual hospitals and prescribers, since supply can generally move through normal channels rather than requiring an SAS application for each patient — though the outcome in any given shortage depends on the TGA's assessment of that specific approval.
What this means for hospital pharmacy and procurement teams
Lead times for both pathways vary depending on the product, the clinical urgency category, and TGA assessment requirements — they are not instantaneous, and timing can't be assumed in advance. Building pathway checks into shortage response planning, rather than starting from scratch once a clinician makes a request, is a reasonable way to reduce avoidable delay, without predicting how long any particular approval will take.
Check the TGA's S19A database as a first step whenever a registered product goes into shortage, before assuming an SAS application is needed.
Confirm that an S19A approval actually covers the intended indication and patient population before ordering — approvals are specific to defined terms, not blanket.
Where SAS may be the relevant pathway, start the conversation with the treating practitioner early — the application sits with them, and eligibility depends on category and circumstance.
Work with suppliers experienced in both pathways, who can support sourcing once the applicable pathway and any required approvals are confirmed.
Common questions
Is the TGA's Section 19A the same as "Section 19A" on the PBS website?
No. The PBS uses a separate "Section 19A" listing mechanism under the National Health Act 1953 for certain subsidised medicines. This article covers the Therapeutic Goods Act 1989 Section 19A shortage pathway, which is a different provision with a different purpose.
Who can apply for a Section 19A approval — can a hospital pharmacist do it?
Generally, no. The application typically sits with the sponsor of the substitute medicine, rather than the hospital. Hospital pharmacy teams generally source the medicine once an approval is in place and listed, though it's worth confirming the specific terms of any given approval.
Does a hospital need to check anything before dispensing a Section 19A-approved medicine?
Yes. Approval is typically specific to a defined indication and patient population, so it's worth confirming the approval covers the intended clinical use before ordering, alongside your organisation's normal clinical governance and quality checks.
How long does approval take under either pathway?
It varies by product, category and the TGA's assessment of the specific circumstances, and timing shouldn't be assumed. Engaging early — with the sponsor for Section 19A matters, or the treating practitioner for SAS — is a reasonable way to avoid unnecessary delay.
How ProPG supports access under both pathways
As an Australian-owned specialist supplier of unlicensed medicines, ProPG works with hospital pharmacy and procurement teams to source and supply medicines under Section 19A approvals and the Special Access Scheme, once the applicable pathway and any required approvals have been confirmed by the relevant sponsor, treating practitioner or TGA process. This sits alongside our broader work on medicine shortages and unlicensed medicine supply for Australian hospitals.
If your hospital or organisation is sourcing a medicine under Section 19A or the Special Access Scheme, get in touch with the ProPG team — we're happy to talk through sourcing options for medicines accessed via either pathway.
