Patient guide
How long does an SAS-B approval last, and what happens when it expires?
If you have been prescribed a medicine under the TGA's Special Access Scheme, there is an approval behind your prescription with a period attached to it. This guide explains what that approval is, what the expiry date means for you, and how renewal works. It is general information, not medical or legal advice.
Verified against the Therapeutic Goods Administration on 7 September 2026. Rules change; check the TGA's own page before you rely on this.
The short answer
- A Special Access Scheme Category B (SAS-B) approval is granted by the TGA to your prescriber, for you, for a set period. It is not open-ended.
- How long it lasts is written on the approval letter. There is no single fixed term, so the date on your letter is the one that counts.
- When it lapses, supply against it stops. A pharmacy cannot dispense on an expired approval, and a new application is needed before anything further is supplied.
- Renewal is a new application by your prescriber, which usually means a review consultation first. The TGA states it processes applications in 2 to 5 days.
- The approval names one practitioner. If you change clinics, your new prescriber applies afresh.
Start here
Three things that are true of every SAS-B approval
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It is granted to your prescriber, not to you
The TGA gives the approval to the health practitioner who applied. That practitioner is the only one authorised to prescribe under it. You are the named patient, and you can ask your clinic for a copy of the letter, but the approval itself belongs to the prescriber.
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It runs for the period on the letter
The TGA’s own wording is that a Category B approval is valid for the period of time specified on the approval letter, as long as the conditions of approval are upheld. Your prescriber nominates an expected duration when applying, and the letter records what was granted.
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The pharmacy checks it before dispensing
Pharmacies can confirm the status of an approval in real time through the TGA’s online system. An expired approval will not be dispensed against, which is why the expiry date matters to you and not only to your clinic.
What it is
The Special Access Scheme, in plain English
Most medicines prescribed in Australia are registered on the Australian Register of Therapeutic Goods. Some are not, and for those the TGA runs the Special Access Scheme, which lets a health practitioner access an unregistered medicine for one named patient at a time.
The scheme has three categories. Category A is a notification for patients who are seriously ill. Category C is a notification for goods with an established history of use. Category B is the application route: the practitioner applies to the TGA, sets out the clinical justification, and must wait for approval before prescribing. Category B is the one this guide is about.
The TGA assesses each Category B application individually. The TGA states that applications are processed in 2 to 5 days, longer if it needs more information, and that the assessing officer is a registered medical practitioner or pharmacist. When the application succeeds, the TGA issues an approval letter signed by a delegate. That letter is the approval.
The approval letter is the approval. Keep it with your prescription details.
The expiry date
What the period on the letter means
A Category B approval is valid for the period of time specified on the approval letter, as long as the conditions of approval are upheld. That is the TGA's own formulation, and the two halves of it both matter. The period is whatever the letter says, because the prescriber nominates an expected duration of treatment when applying and the TGA records what it granted. And the approval depends on its conditions continuing to be met, which is the prescriber's responsibility to maintain.
The TGA does not publish one fixed term for Category B approvals. Different applications carry different periods. If you have not seen your letter, or you do not know the date on it, your clinic can tell you.
Once the period ends, the TGA's system moves the approval into an expired state and supply against it stops. Pharmacies can check the status of an approval in real time before dispensing, so an expired approval is not something a pharmacy will fill in the meantime. Anything further requires a new application, granted before supply.
Renewal
How a renewal actually works
A renewal is a new Category B application, submitted by your prescriber. The TGA's online system lets a prescriber base a new application on a previous one, but it is still assessed as a fresh application, and it still needs to be approved before anything is supplied against it. In practice that means a review consultation first, so that the prescriber can confirm the clinical picture the application describes.
The TGA's system flags an approval to the prescriber as expiring when fewer than 14 calendar days of its period remain. Clinics generally run earlier reminders of their own. Either way, 14 days is the floor, not a target: a review, an application and a few days of TGA processing all have to fit inside whatever time is left.
The practical steps on your side are short: know the date on your letter, book your review before it rather than after, and keep a copy of the approval letter with your prescription details, because it answers most questions a pharmacy or a new clinic will ask.
Read this if you are changing clinics
Your approval names your prescriber, so it does not move with you
The TGA grants the approval to the practitioner who applied, and only that practitioner can prescribe under it. When you transfer to a new clinic, your new prescriber makes a new application. An existing approval letter and your current prescription details are the most useful things you can bring to that first consultation. If you are in the middle of a transfer, our changing clinics page sets out what to bring and what to expect.
Your approval and its expiry: common questions
What is an SAS-B approval?
The Special Access Scheme is the TGA pathway that lets a health practitioner access a medicine that is not registered in Australia for one named patient. Category B is the application route: the practitioner applies to the TGA and must wait for approval before prescribing. The approval is specific to that practitioner, that patient, and the product category applied for. This is general information, not medical or legal advice.
How long does an SAS-B approval last?
For the period of time specified on the approval letter signed by the TGA delegate, as long as the conditions of approval are upheld. The TGA does not publish a single fixed term for Category B, so the date on your letter is the one that applies. If you do not know your expiry date, ask your clinic.
Who applies for the approval, me or my clinic?
Your prescriber. The TGA requires the practitioner to be the named applicant, and only the practitioner named on the approval letter can prescribe under it. Patients do not apply to the TGA directly.
How long does the TGA take to decide?
The TGA states that applications are processed in 2 to 5 days, and may take longer if it needs to ask the prescriber for more information. Each application is assessed by a TGA officer who is a registered medical practitioner or pharmacist.
What happens when my approval expires?
Supply against it stops. The TGA’s system marks an approval as expired once it passes the end of its period, and a pharmacy will not dispense against an expired approval. A new application is needed before anything further can be supplied, and that usually follows a review consultation with your prescriber.
Will anyone warn me before it expires?
The TGA’s online system flags an approval to the prescriber as expiring when fewer than 14 calendar days of its period remain. Clinics generally run their own earlier reminders on top of that, but the safest approach is to know your own date and book a review well before it.
Does the approval move with me if I change clinics?
No. The approval names one practitioner, and only that practitioner can use it. If you transfer to a new clinic, your new prescriber makes a new application to the TGA. Bringing your existing approval letter and current prescription details to the first consultation makes that quicker to prepare.
Is a state or territory approval separate from the TGA approval?
In some jurisdictions, yes. A state or territory health department approval or notification can also apply, with its own timing, and the TGA’s online system lets the prescriber handle both in the one submission where required. Your clinic manages this; you do not need to apply to a state health department yourself.
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