The Special Access Scheme, in plain English
How Australians can sometimes access medicines that are not on the general market. Not medical advice.
This page explains how Australia's Special Access Scheme works. It is a plain English guide to the pathways that exist. It is not a lookup tool, and it cannot tell you whether a specific medicine is available for your situation. Only your doctor can work that out with you.
The three main pathways
The Special Access Scheme is the way a doctor can arrange a medicine that is not otherwise approved for general supply in Australia. There are three pathways. Which one applies depends on how urgent the situation is and whether the medicine is already on a government list.
Category A
This pathway is for people who are seriously ill. A doctor can arrange the medicine straight away and then tells the TGA afterwards. It is meant for urgent situations where waiting for approval would put the person at serious risk. Only a medical practitioner can use this pathway.
Category B
This pathway is an application. The practitioner sends a request to the TGA and waits for a decision before the medicine can be supplied. It is used when the situation does not fit Category A and the medicine is not on the Category C list. The TGA looks at each request on its own facts.
Category C
This pathway is built around a published list. The government keeps a list of medicines that have a well understood history of use for certain purposes. When a medicine and its use are on that list, an approved type of health practitioner can supply it and then notify the TGA, without waiting for approval first. It only covers the exact medicines and uses named on the list.
How to find out if a specific medicine is on the Category C list
The Category C list is kept up to date by the TGA. Voxsanity does not currently reproduce it in a searchable form, so use the TGA's list directly to check a specific medicine.
Open the TGA Special Access Scheme Category C lists
Source: the lists are made under the Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022, published on the Federal Register of Legislation at legislation.gov.au. Separate instruments cover biologicals and medical devices. Voxsanity does not reproduce any of these lists.
The Authorised Prescriber arrangement
Authorised Prescriber
Separate from the three SAS pathways, the TGA can authorise a specific doctor to prescribe a specific unapproved medicine to patients in their care with a particular condition. This is called being an Authorised Prescriber. Once it is granted, that doctor can prescribe the medicine to eligible patients without a separate application each time. Whether this arrangement applies is a decision for the doctor and the TGA.
Compassionate access, and how it differs from the SAS
Compassionate access is not part of the Special Access Scheme. The three pathways above are TGA arrangements that let a health practitioner supply a medicine that is not approved for general supply in Australia; compassionate access is something a manufacturer offers, and the TGA does not run it.
Some manufacturers run compassionate access or early access programs that provide a medicine at reduced or no cost to patients who meet criteria the manufacturer sets, sometimes before or around the time of approval. These programs are run by the manufacturer rather than the government, and a doctor arranges them. What is available changes over time, so this is a question for your doctor.
An important note
The information on this page describes how the Special Access Scheme works in general. It does not tell you whether a specific medicine is accessible for a specific condition. A patient cannot apply for SAS access themselves; it has to be done by a health practitioner registered with AHPRA. For Category A, and to become an Authorised Prescriber, that practitioner must be a medical practitioner. For Categories B and C the TGA also allows certain other registered health practitioners to be the named prescriber, within their own scope of practice and subject to conditions it sets for each category. The TGA publishes a searchable table of exactly who is eligible for which pathway: see its Special Access Scheme guidance for health practitioners. Always speak to your doctor about your specific situation.
What you could ask your doctor
If you think the Special Access Scheme might be relevant to you, these are some questions you could raise at an appointment. They are suggestions to help start a conversation, not instructions.
- Is there a Special Access Scheme pathway for this medicine?
- Would this fall under Category C, or would it need a Category B application?
- What would the process and the timing look like for me?
Learn more
Not medical advice. Information on this site does not constitute medical advice. Data is sourced from public government registries and other public data sources. Always consult your doctor before making any health decisions. Trial status should be verified directly with the trial site.