Patient guide
How to get a prescription for an unapproved medicine in Australia
Some medicines prescribed in Australia are not on the Australian Register of Therapeutic Goods. For those, a prescription needs two decisions: your prescriber’s, and an approval from the Therapeutic Goods Administration, usually through the Special Access Scheme Category B (SAS-B). General information, not medical or legal advice.
By Umar Khan, CEO. Checked against the TGA and state health departments, 16 October 2026. Rules change; the TGA's own page is the one to rely on.
Key points
- An unapproved medicine is one that is not entered on the Australian Register of Therapeutic Goods (ARTG). A practitioner can still prescribe it for one named patient once the TGA approves an application.
- You do not apply to the TGA yourself. A prescriber applies after a consultation, and only if they decide the medicine is clinically appropriate for you.
- The TGA states that it processes Special Access Scheme Category B (SAS-B) applications in 2 to 5 days, and longer when it asks the prescriber for more information.
- Some states and territories add an approval of their own. The ACT requires one for every prescription of a controlled medicine; Victoria, NSW, Western Australia and South Australia require one in defined circumstances.
- The approval names the prescriber and runs for the period written on the approval letter. A new prescriber means a new application.
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.
Start here
What is an unapproved medicine, and what is SAS-B?
Most medicines prescribed in Australia are entered on the Australian Register of Therapeutic Goods. The TGA calls a medicine that is not on the register an unapproved therapeutic good. It can still be prescribed, but only through a pathway the TGA controls, one patient or one class of patients at a time.
The Special Access Scheme is the pathway for individual patients, and it has three categories. Category A is a notification for patients who are seriously ill. Category C is a notification for goods on the TGA’s established history of use list. Category B is the application route: the prescriber applies, the TGA assesses, and nothing is supplied until the TGA approves. Category B, usually written SAS-B, is the route this guide follows.
The other route is the Authorised Prescriber Scheme, under which the TGA authorises a medical practitioner to prescribe a specified unapproved medicine to a class of patients without a separate application for each one. Clinics that work through SAS-B, LeafLine Clinic included, apply patient by patient.
Australian advertising law stops a clinic from naming prescription medicines or discussing their outcomes in public material, so this guide covers the process. Specific treatment options can only be discussed with a practitioner in a private consultation.
Step by step
How do you get a prescription through SAS-B?
-
Book a consultation with a prescriber
Start with a consultation with a registered health practitioner who can prescribe. The TGA says what a practitioner can access depends on their scope of practice, qualifications, the condition being treated and state and territory requirements.
The TGA’s Category B requirements do not include a referral. Some clinics ask for one; LeafLine Clinic does not. A real-time telehealth consultation by video or telephone can be that consultation.
-
The prescriber assesses you
The prescriber takes your history, reviews the treatments you have already tried, considers registered options on the ARTG first, checks for anything that makes an unapproved medicine unsuitable, and discusses risks with you before you give informed consent.
The TGA’s conditions for SAS prescribers require them to use the scheme in exceptional circumstances after first considering appropriate ARTG-registered treatments, to follow good medical practice and to obtain informed consent.
-
The prescriber applies to the TGA
If the prescriber decides an unapproved medicine is appropriate, they submit a Category B application through the TGA’s Special Access Scheme and Authorised Prescriber Online System, with a clinical justification written for you specifically.
The TGA asks for a brief justification covering previous treatments, why ARTG-registered options may not suit, and the expected benefits weighed against the risks. A prescriber without experience in the medicine or the condition must attach a letter of support from an appropriate specialist.
-
Any state or territory approval is lodged
Where your state or territory requires its own approval, the prescriber applies for it too, usually in the same online submission. Nothing is prescribed until every required approval is granted.
The table further down sets out what each jurisdiction adds.
-
The TGA assesses the application
A TGA officer who is a registered medical practitioner or pharmacist assesses the application case by case. The TGA states it processes applications in 2 to 5 days.
The outcome is an approval letter signed by a TGA delegate, or a refusal with reasons. An application can also be returned with a request for more information, which adds time.
-
The prescription is written and dispensed
Once approved, the prescriber writes the prescription. The dispensing pharmacy checks the approval in real time through the TGA’s online system before it supplies anything.
Supply under the approval continues for the period written on the letter, with reviews along the way. When the period ends, a further application is needed before any more is supplied.
The consultation
What does the Clinician assess before applying?
-
Your history
Your medical history, current medicines and doses, other conditions, and what has already been tried, for how long, and how it went. Letters, results and discharge summaries help.
-
Whether it is suitable
Anything that makes an unapproved medicine a poor fit for you, including mental health history, pregnancy or breastfeeding, interactions with what you already take, and your driving and work.
-
Registered options first
Whether an ARTG-registered medicine would suit, because the TGA expects prescribers to consider those first. A prescriber can decide not to apply, and that decision is theirs to make.
The assessment feeds the clinical justification the TGA asks for, which has to be written for you rather than copied across patients. If the Clinician decides an unapproved medicine is not appropriate, they do not apply, and they tell you why. At LeafLine Clinic that consultation is held by video or telephone with an AHPRA-registered Clinician, and the clinic sees adults aged 18 and over.
State and territory approvals
Does your state need its own approval as well?
The TGA approval is federal and the same everywhere. Each state and territory then sets its own rules for prescribing in its jurisdiction, and every one runs a real-time prescription monitoring system the prescriber checks. Where a state approval applies, it is issued to the prescriber and lodged alongside the federal application.
| Jurisdiction | What the state or territory adds | Monitoring system |
|---|---|---|
| Victoria | Department of Health permit before prescribing to a patient with a history of drug dependence. | SafeScript |
| New South Wales | NSW Health authority where the prescriber considers the patient drug dependent. From 5 November 2026 applications go through SafeScript NSW under the new Act. | SafeScript NSW |
| Queensland | No state approval for an adult. The prescriber must check QScript before every monitored prescription. | QScript |
| Western Australia | Department of Health approval in defined situations, including a recent history of drug dependence or substance use disorder, a psychiatric history alongside the reason for treatment, or a dose above the published ceiling. | ScriptCheckWA |
| South Australia | SA Health authority under s 18A of the Controlled Substances Act 1984 (SA) once treatment passes two months, counting time with a previous prescriber. People aged 70 or over and Notified Palliative Care Patients are exempt. | ScriptCheckSA |
| Australian Capital Territory | ACT Chief Health Officer approval for controlled medicines, lodged on the same form as the federal application. Written notice within 7 days of the decision. | Canberra Script |
| Northern Territory | No specific Territory regulation for this kind of prescribing. Treating addiction needs a Chief Health Officer authorisation available only to practitioners practising in the Territory. | NTScript |
| Tasmania | Separate prescriber authorisation rules under the Poisons Act 1971 (Tas). LeafLine Clinic cannot currently take on patients located in Tasmania. | TasScript |
Summarised from state legislation and health department guidance verified in September 2026. Each jurisdiction links to our page for that state, which carries the detail and the sources. There is also a page for every town and city of 10,000 people or more, with the rules for that state.
TGA processing starts when the prescriber submits, after your consultation.
Timing
How long does SAS-B approval take?
The TGA states that it processes Category B applications in 2 to 5 days, and that an application can take longer if it needs to ask the prescriber for more information. The clock starts when the prescriber submits, which is after your consultation, not before it.
A state approval adds its own timing where one applies. The ACT Regulation requires written notice within 7 days of the Chief Health Officer’s decision; Victoria, NSW, Western Australia and South Australia process their permits and authorities on their own timetables. A complete application, with prior treatments, current medicines and any specialist letter attached, avoids the most common cause of delay, which is a request for more information.
After approval
What happens after the TGA approves?
The TGA issues an approval letter signed by a delegate. The letter names the prescriber, the patient and the product category applied for, and it carries the period the approval runs for. You can ask your clinic for a copy, and it is worth keeping with your prescription details.
The prescriber then writes the prescription; at LeafLine Clinic prescriptions are issued electronically. The pharmacy that dispenses it checks the approval’s status in real time through the TGA’s online system before supplying anything, and it will not dispense against an approval that has expired.
Reviews follow at intervals your prescriber sets. The prescriber is responsible for reporting any adverse event to the TGA. When the period on the letter is close to ending, the TGA’s system flags the approval to the prescriber as expiring at 14 days, and a further supply needs a new application, usually after a review. Our guide to your approval and when it expires covers renewal in detail, and renewing by telehealth covers how far ahead to book.
Costs
What does it cost?
Two costs sit side by side, and they are paid to different people. The clinic charges for the consultations: the assessment, any application the prescriber decides to make, and the reviews that follow. The pharmacy charges for any medicine it dispenses, at a price it sets. Unapproved medicines are generally not listed on the Pharmaceutical Benefits Scheme, so that price carries no PBS subsidy.
At LeafLine Clinic the initial consultation is $29 (usually $79), and follow-up consultations are $59 to $69. Every fee is on the fees page before you book, and the consultation fee does not include any medicine.
Already prescribed elsewhere?
An approval stays with the prescriber who applied
If you already hold a prescription under SAS-B and want to move clinics, your new prescriber makes a fresh application in their own name, and any state approval is applied for again. Our changing clinics page sets out how a transfer works, and when your Clinician changes covers a change of prescriber inside the same clinic.
Your SAS-B questions
Every part of an SAS-B approval, one guide each
-
Approval or script?
The difference between the TGA approval and the prescription, and why a pharmacy needs both.
-
When does an SAS-B approval expire?
The period on the letter, the 14-day expiring flag, and what happens when it lapses.
-
What an SAS-B approval covers
One prescriber, one patient, the use described in the application, and the four TGA conditions.
-
Renewing an SAS-B approval
Why a review consultation comes first and how far ahead to book it.
-
Changing clinics, step by step
Why a new prescriber applies afresh, what to bring, and how to avoid a gap in supply.
-
When your Clinician changes
What happens to your approval when your prescriber leaves or is away.
Getting a prescription through SAS-B: common questions
What is an unapproved medicine?
A medicine that is not entered on the Australian Register of Therapeutic Goods (ARTG), so it has not been evaluated by the TGA for general supply in Australia. A practitioner can still prescribe one for a named patient under a TGA pathway such as the Special Access Scheme. This is general information, not medical or legal advice.
Can I apply to the TGA for SAS-B approval myself?
No. The applicant is the prescriber. The TGA requires a registered health practitioner to submit the application, and only the practitioner named on the approval letter can prescribe under it. Your part is the consultation and your informed consent.
Who can prescribe through SAS-B?
A registered health practitioner who is eligible to prescribe, working within their scope of practice. The TGA states that what a practitioner can access depends on their scope of practice, qualifications, the condition being treated and state and territory requirements, and a practitioner without experience in the medicine or condition needs a letter of support from an appropriate specialist.
How long does SAS-B approval take?
The TGA states that it processes applications in 2 to 5 days, and that it can take longer if it needs more information from the prescriber. A state or territory approval, where one applies, runs on that department’s timing; the ACT, for example, must give written notice within 7 days of deciding. Nothing is prescribed until every required approval is granted.
Is a prescription guaranteed if I book a consultation?
No. The prescriber decides whether an unapproved medicine is clinically appropriate and whether to apply at all, and the TGA decides whether to approve the application. Specific treatment options can only be discussed with a practitioner during a private consultation.
Do I need a referral from my GP?
The TGA’s Category B requirements do not include a referral. Whether you need one depends on the clinic; LeafLine Clinic does not ask for one. If you have a regular GP, telling them about any new medicine keeps your care joined up.
How long does an SAS-B approval last?
For the period of time specified on the approval letter, as long as the conditions of approval are upheld. There is no single fixed term. Our guide to approvals and expiry covers what happens when the period ends and how renewal works.
What does it cost?
There are two separate costs. The clinic charges for consultations: at LeafLine Clinic the initial consultation is $29 (usually $79) and follow-ups are $59 to $69, all published before you book. The pharmacy sets the price of any medicine dispensed, and unapproved medicines are generally not listed on the Pharmaceutical Benefits Scheme, so that price is not subsidised.
Is an SAS-B approval the same as a script?
No. The approval is the TGA’s permission for your prescriber to prescribe an unapproved medicine for you, for the period on the approval letter. The prescription (the script) is your prescriber’s instruction to the pharmacy to dispense. A pharmacy needs both to be current before it can dispense.
Do I get a copy of the SAS-B approval letter?
The approval letter is issued to your prescriber, because the approval belongs to them. You are the named patient and you can ask your clinic for a copy for your own records, which is worth having if you ever change clinics.
What happens if I change clinics or prescribers?
The approval names the prescriber, so a new prescriber makes a new application in their own name, and any state approval is applied for again as well. Bring your existing approval letter and prescription details to your first consultation with them.
Sources
- Therapeutic Goods Administration, Access unapproved therapeutic goods for individual patients: Special Access Scheme (page last updated 3 December 2025). Categories, application content, letters of support, 2 to 5 day processing, approval period.
- Therapeutic Goods Administration, Special Access Scheme and Authorised Prescriber Online System guidance, version 1.9 (March 2024). Prescriber responsibilities, the 14-day expiring flag, pharmacist validation, state notifications in the same submission.
- State and territory rules: our changing clinics pages, each verified against that jurisdiction’s legislation and health department guidance in September 2026.
Ready to get started?
Take the first step. A simple conversation with a Clinician.
AHPRA-registered Clinicians · Australian-owned and operated · Telehealth nationwide