The Special Access Scheme (SAS) is the process a prescriber uses to get approval from the Therapeutic Goods Administration (TGA) to supply an unapproved medicine to one individual patient.1 Almost every CBD oil in Australia is an unapproved medicine, so the SAS is one of the two main routes by which CBD is lawfully prescribed. The other is the Authorised Prescriber scheme.2
What does “unapproved” mean?
The medicine is not on the Australian Register of Therapeutic Goods. The TGA says such medicines “have not been assessed by the TGA with regards to safety, quality, and effectiveness”.1 Practitioners may use the SAS for cannabis medicines “if all other clinically appropriate treatment options on the ARTG have been considered”.2
What is SAS-B?
Category B, the one most used for cannabis medicines. The prescriber applies online and waits for a TGA approval letter before prescribing.1 Category A is a notification pathway for seriously ill patients.1
The application names a category of product by its active ingredients, not a brand.3 For CBD-only products that is Category 1, where CBD is 98% or more of the cannabinoids.4 The prescriber must summarise the patient’s condition, “relevant past treatments and procedures trialled or considered”, and the expected benefits against the risks.1
How long does it take?
The TGA says: “Your application will be processed in 2 to 5 days. It may take longer if we need to ask you for more information.”1 That covers only the TGA’s step, not booking an appointment or the pharmacy ordering the product.
Who can apply?
A registered health practitioner. Category B is open to “medical and other health practitioners”, which includes nurse practitioners.1 Patients cannot apply themselves.2
Does approval mean the product is “TGA approved”?
No. The product stays unapproved, and the prescriber must tell the patient that its “safety, quality and efficacy … may not be well established for their condition”.5 For many conditions, controlled trials of CBD have found no benefit over placebo. See does CBD help pain?
How much is it used?
The TGA approved 177,762 Category B applications for medicinal cannabis in 2024. Of those, 29,165 were for CBD-only oral liquids.36 These are approvals, not people.
Read the full guide: the Special Access Scheme explained.
Footnotes
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Therapeutic Goods Administration. Access to unapproved therapeutic goods for individual patients (Special Access Scheme), updated 3 December 2025. https://www.tga.gov.au/business-services/special-access-scheme-and-authorised-prescriber-online-system/access-unapproved-therapeutic-goods-individual-patients-special-access-scheme ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7
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Therapeutic Goods Administration. Access pathways for medicinal cannabis. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/access-pathways ↩ ↩2 ↩3
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Therapeutic Goods Administration. Consultation paper: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products, August 2025. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/user_uploads/final---consultation-paper---medicinal-cannabis-review---august-2025.pdf ↩ ↩2
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Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026, cannabidiol entries. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩
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Therapeutic Goods Administration. Do your patients know the risks of unapproved medicinal cannabis products?, 2 June 2026. https://www.tga.gov.au/news/blog/do-your-patients-know-risks-unapproved-medicinal-cannabis-products ↩
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Therapeutic Goods Administration. FOI 25-0200: Category 1 (CBD) medicinal cannabis approvals and supply data, 2025. https://www.tga.gov.au/sites/default/files/2025-06/FOI%2025-0200.pdf ↩
This page is general information, not medical or legal advice. Laws and evidence change; we show the date we last checked the facts at the top of every page. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.
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