Patient guide
What does an SAS-B approval actually cover?
Your approval is the TGA’s answer to the application your Clinician lodged. It names one prescriber and one patient, it covers the product and use that the application described, and it carries four standard conditions. It does not guarantee supply and it is not a prescription. General information, not medical or legal advice.
Last verified 20 October 2026 against the TGA Special Access Scheme pages. Rules change; check with your clinic before you rely on this.
Part of our guide to how an SAS-B approval works, start to finish.
The short answer
- An SAS-B approval is the TGA’s permission for one named prescriber to prescribe one unapproved product for one patient. It is built from the application your Clinician lodged, so it covers what that application described and nothing wider.
- The application sets out the product, its strength and form, the dose and how often it is taken, and how long or how much is needed. The TGA’s first standard condition is that the product is used only in the manner described.
- Every approval carries four standard conditions, and the TGA can add more. Your Clinician holds the approval and accepts responsibility for the outcome.
- An approval is not a supply guarantee and not a prescription. The TGA states that suppliers are under no obligation to supply, and a prescription is still needed before a pharmacy dispenses.
Changing clinics
Moving your care from another clinic?
Our changing clinics page explains what to bring: your current prescription details and, if you have one, a treatment summary. A LeafLine Clinician reviews your history at a first consultation and decides what happens next.
At a glance
What an SAS-B approval sets, line by line
Each row comes from the application your Clinician lodged or from the conditions the TGA attaches to every approval.
| Item | What the approval sets | Source |
|---|---|---|
| Who can use it | One prescriber, named on the letter. A colleague in the same clinic cannot prescribe under it | TGA SAS page |
| Who it is for | You. The application identifies you with three identifiers, such as your initials, gender and date of birth | TGA online system user guide |
| What it covers | The product described in the application: active ingredient, strength, dosage form, route, dose and frequency, and the duration or quantity needed | TGA online system user guide; SAS guidance, condition 1 |
| How long it lasts | The period written on the letter, while the conditions are met. The TGA system marks an approval as expiring when fewer than 14 days remain | TGA SAS page; online system user guide |
| The conditions | Four standard conditions on every approval, plus any the TGA delegate adds | TGA SAS guidance |
| The reference | An approval number, printed in the letter. Another registered practitioner, such as the dispensing pharmacist, can check a current approval in the TGA online system | TGA SAS page; online system user guide |
| What it does not do | Guarantee supply, replace a prescription, or override a state or territory rule | TGA SAS page; SAS guidance |
Current at 20 October 2026. General information, not medical or legal advice. Sources, all read 20 October 2026: TGA, Special Access Scheme guidance for health practitioners accessing unapproved therapeutic goods (last updated 1 October 2024); TGA, Access to unapproved therapeutic goods for individual patients (Special Access Scheme) (last updated 3 December 2025); TGA, Special Access Scheme online system user guide, version 2.0 (26 May 2026); TGA, Access an unapproved therapeutic good, for health practitioners (last updated 7 October 2026). The TGA pages describe what an application must contain and what conditions attach to an approval. They do not publish the layout of the letter itself, so the table describes what the approval sets rather than where each detail sits on the page.
Start here
Three rules behind the table
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It mirrors the application
The TGA decides on the application in front of it. The approval covers the patient, product and use that the application described, for the period written on the letter.
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It is held by your Clinician
The TGA sends the approval letter to the practitioner who applied, at the email address on the application. The named prescriber is the only practitioner authorised to use it.
-
It permits, it does not supply
The approval makes it lawful to prescribe the product for you. Finding stock, writing the prescription and meeting any state rule are separate steps.
The conditions
What the four standard conditions mean for you
The TGA attaches these four conditions to every Category B approval, and the delegate can add others (TGA SAS guidance, read 20 October 2026).
- 01
The product is used only in the manner described in the application
The application named the product, strength, form, route, dose and frequency. Using it differently from that description falls outside the approval, which is why a change usually goes back to your Clinician first.
- 02
The approval holder accepts responsibility for the outcome
Responsibility sits with the prescriber who holds the approval. The TGA delegate reviews the application but, in the TGA’s words, the review is not an evaluation of the product’s quality, safety or efficacy.
- 03
Adverse events and defects are reported to the TGA
Your Clinician has to report problems to the TGA. Tell your Clinician about any side effect or any fault with what you were supplied, even if it seems minor.
- 04
The product is used with fully informed consent
Before prescribing, your Clinician explains that the product is not on the Australian Register of Therapeutic Goods, what is known about its risks and what approved alternatives exist, and records your consent in your file.
The letter goes to your Clinician and sits on your file at the clinic.
The letter
Who receives the approval, and who can check it
The TGA emails the approval letter to the practitioner who applied, at the address given on the application, and a TGA delegate signs it. The letter carries an approval number. Your Clinician keeps it on your clinical record, alongside the application and your consent (TGA SAS page and SAS guidance, read 20 October 2026).
Other people check the approval without needing the letter itself. The TGA online system lets a logged-in health practitioner, such as a dispensing pharmacist, enter the submission number and see whether the approval is current. A supplier may also ask the prescriber for a copy before it releases stock (TGA online system user guide, read 20 October 2026).
None of the TGA pages we read says whether you receive a copy. You can ask your clinic for one. The letter is part of your health record, and Australian privacy law gives you a general right to access your health information.
The limits
What an approval does not do
An approval does not put stock on a shelf. The TGA states that suppliers are under no obligation to supply an unapproved product, and the TGA does not arrange supply itself (TGA SAS page, read 20 October 2026). Your Clinician and the dispensing pharmacy work out where the product comes from, and the pharmacy supply guide covers what happens when it runs out.
An approval is not a prescription either. It makes it lawful for your Clinician to prescribe the product for you, and the pharmacy still needs a valid prescription before it dispenses. Nor does the approval settle the state layer. The TGA states that its approval does not override any state or territory requirement, and some states need their own permit or approval in defined cases.
The approval also stops at the edges of the application. A different product, a different strength or a different way of taking it may need a new application, because the first condition ties the approval to the manner described. The TGA states that it processes applications in 2 to 5 days. The approval expiry guide explains what the period on the letter means and what happens when it runs out.
Worth doing once
Ask your clinic for three details
The date your approval runs to, whether it covers the strength and form you are taking now, and how many repeats remain on your current prescription. Those three answers tell you when to book your next review and whether a change you have discussed with your Clinician needs a new application first. The renewal guide sets out how far ahead to book, and LeafLine patients can reach the team through the support page.
SAS-B approvals: common questions
What is an SAS-B approval?
It is a decision by the TGA under the Special Access Scheme, Category B, that lets one named prescriber prescribe an unapproved therapeutic good for one patient. The prescriber applies, the TGA reviews the application, and the approval covers what the application described. This is general information, not medical or legal advice.
Do I get a copy of the approval letter?
The TGA emails the letter to the practitioner who applied, at the address on the application. None of the TGA pages we read says whether the patient receives a copy. Ask your clinic if you would like one; the letter is part of your clinical record, and you have a general right to access your health information.
Does the approval cover a different product or dose?
The first standard condition is that the product is used only in the manner described in the application. A change to the product, the strength or the way it is taken may therefore need a new application. Your Clinician decides whether one is needed.
Does an approval mean the pharmacy will have stock?
No. The TGA states that suppliers are under no obligation to supply an unapproved product, and the TGA does not arrange supply itself. Our guide on what happens when the pharmacy cannot supply covers the steps if stock runs out.
Is the approval the same as a prescription?
No. The approval makes it lawful for your Clinician to prescribe the product for you. A pharmacy still needs a valid prescription before it can dispense, and it can check a current approval in the TGA online system.
How long does the approval last?
For the period written on the approval letter, as long as the conditions of approval are met. There is no single fixed term. The TGA online system marks an approval as expiring when fewer than 14 days remain, and our approval guide explains what happens at expiry.
Can another Clinician use my approval?
No. The TGA states that the prescriber named on the approval letter is the only practitioner authorised to use it. A new Clinician, in the same clinic or a different one, applies in their own name.
What if the TGA does not approve the application?
The TGA must notify the applicant of its decision within 28 days of making it, with reasons if it refuses. Under section 60 of the Therapeutic Goods Act 1989, a person whose interests are affected can ask the Minister to reconsider within 90 days of the notice. Your Clinician will explain what the decision means for your care.
Does the TGA approval cover my state as well?
Not on its own. The TGA states that its approval does not override any state or territory requirement. Some states need a separate permit or approval in defined cases, and your Clinician checks what applies where you live.
What if a detail about me looks wrong?
Tell your clinic. The application identifies you by three details, such as your initials, gender and date of birth, and the TGA pages we read do not set out a correction process for patients. Your Clinician is the applicant, so they are the person who deals with the TGA.
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