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The Special Access Scheme (SAS-B) explained

The Special Access Scheme lets a prescriber apply to the TGA to supply an unapproved medicine, such as CBD oil, to one patient. How Categories A, B and C work.

Facts checked 13 November 20266 min readHow we research

The Special Access Scheme (SAS) is the process a health practitioner 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

“SAS-B” means Category B of the scheme, the one most often used for cannabis medicines.

Why does the scheme exist?

Medicines normally have to be on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. Getting on the register means the TGA has assessed the product. Medicines that are not on it are called “unapproved”, and the TGA says they “have not been assessed by the TGA with regards to safety, quality, and effectiveness”.1

The SAS is an exception for individual patients. The TGA says practitioners may use it for cannabis medicines “if all other clinically appropriate treatment options on the ARTG have been considered”.2

What are the categories?

Category When it applies What the prescriber does
A The patient is seriously ill, with a condition from which death is reasonably likely within months, or premature death is likely without early treatment A medical practitioner supplies the medicine and notifies the TGA within 28 days
B Any case not covered by A or C The prescriber applies and waits for a TGA approval letter before prescribing
C The medicine is on the TGA’s list of goods with an established history of use, for that practitioner type and condition The prescriber supplies the medicine and notifies the TGA within 28 days

Source: TGA.1

The TGA’s page for prescribers says: “If you want to access medicinal cannabis, it is generally faster to do so through the application pathway (Category B).”1

Who can apply?

A practitioner registered with the Australian Health Practitioner Regulation Agency (Ahpra). Category A is for medical practitioners only. Category B is open to “medical and other health practitioners”, which includes nurse practitioners, and what each can access “depends upon your scope of practice, qualifications, condition being treated and state and territory requirements”.1 Another health practitioner, such as a pharmacist, can submit the form on the prescriber’s behalf.1

Patients cannot apply. Healthdirect notes that the doctor completes the forms to get the necessary government approvals.3 See who can prescribe CBD.

What goes into a Category B application?

Applications are made through the TGA’s online system. Since 2021 they have named a category of product by its active ingredients, not a brand.4 For CBD-only products that is Category 1, where CBD is 98% or more of the cannabinoids, which is also the legal definition of a Schedule 4 CBD medicine.56

The prescriber must give a brief clinical justification. According to the TGA it should summarise:1

  • the patient’s symptoms or diagnosis, and how serious the condition is
  • “relevant past treatments and procedures trialled or considered”, including why medicines on the register may not be the most appropriate
  • “an appraisal of the expected clinical benefits versus the potential risks”.

If the prescriber does not have experience with the product or the condition, the TGA says they “must get a letter of support from an appropriate specialist”.1 For patients under 18, the TGA expects supporting evidence from a paediatrician or relevant specialist.4

This is the prescriber’s document, written from the clinical record. It is one reason a prescriber will ask in detail what a patient has already tried.

How is the application decided?

A TGA officer who is a registered medical practitioner or pharmacist assesses it. “Decisions are made on a case-by-case basis.”1

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 is the TGA’s stated time for its own step. It does not include booking a consultation or the pharmacy obtaining the product.

What happens after approval?

  • The TGA sends the prescriber an approval letter with an approval number. Only the practitioner named on the letter can use it.1
  • The approval “is valid for the period of time specified on the approval letter”, provided its conditions are met.1
  • The TGA does not supply the medicine. The prescriber is responsible for sourcing it, usually together with the dispensing pharmacy. Suppliers are “under no obligation to supply”.1
  • TGA approval “does not override any State or Territory requirements”. Some products need a state approval as well.1 The TGA notes that some states, such as Tasmania, have extra requirements for CBD products even when they are Schedule 4.7

Then the prescription is written and dispensed. See filling a CBD prescription.

What does approval not mean?

It is easy to read “TGA approved” into this process. That would be wrong.

  • The product remains unapproved. The TGA has not assessed whether it works or is safe.2
  • The prescriber must tell the patient so. The TGA says patients should understand that the product “is unapproved and not included in the ARTG” and that its “safety, quality and efficacy … may not be well established for their condition”.8
  • Advertising law prohibits implying that a medicine is approved or endorsed by the TGA.9

Approval also says nothing about how good the evidence is for a particular condition. For many conditions, controlled trials of CBD have found no benefit over placebo.101112 See the conditions section.

What are the prescriber’s continuing duties?

A prescriber who uses the SAS must report any suspected side effect (adverse event) or product defect to the TGA within 15 days of learning of it.1 The TGA also expects documented informed consent and ongoing monitoring.8 If you have an unexpected reaction, tell the prescriber. See CBD side effects.

How much is the scheme used?

The TGA approved 57,711 Category B applications for medicinal cannabis in 2020 and 177,762 in 2024.4 Of the 2024 total, 29,165 were for CBD-only oral liquids.13 These are approvals, not people: the TGA counts approvals and units, not patients.5

In the year to October 2025, the Penington Institute reported that chronic pain (43.8%) and anxiety (31.2%) were the most common reasons given on applications for cannabis medicines of all types.5 That describes what prescribers applied for. It is not evidence that the medicines work for those conditions. See CBD for chronic pain and CBD for anxiety for what trials of CBD found.

Is the scheme likely to change?

Possibly. The TGA consulted on unapproved cannabis medicines from August to October 2025 and reported that stakeholders agreed the current framework is “not fit-for-purpose”.14 Its staged plan includes reviewing scheduling and quality requirements, with longer-term reform options to go to government.15 As of November 2026 we found no announced decision to change the scheme. See how the TGA regulates CBD.

Footnotes

  1. 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 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13 ↩14 ↩15

  2. Therapeutic Goods Administration. Access pathways for medicinal cannabis. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/access-pathways ↩ ↩2 ↩3

  3. Healthdirect Australia. Medicinal cannabis, last reviewed February 2026. https://www.healthdirect.gov.au/medicinal-cannabis ↩

  4. 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 ↩3

  5. Penington Institute. Cannabis in Australia, November 2025. https://www.penington.org.au/wp-content/uploads/2025/11/Penington_Institute_Cannabis-in-Australia_Nov_2025.pdf ↩ ↩2 ↩3

  6. 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 ↩

  7. Therapeutic Goods Administration. Medicinal cannabis: importation and the traveller’s exemption, updated 29 January 2025. https://www.tga.gov.au/resources/explore-topic/medicinal-cannabis-hub/medicinal-cannabis-information-patients/medicinal-cannabis-importation-and-travellers-exemption ↩

  8. 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 ↩ ↩2

  9. Therapeutic Goods Administration. Advertising guidance for businesses involved with medicinal cannabis products, December 2023. https://www.tga.gov.au/sites/default/files/2023-12/advertising-guidance-businesses-medicinal-cannabis-products.docx ↩

  10. Bebee B and others. Cannabidiol for acute low back pain (CANBACK trial), Medical Journal of Australia, 2021. https://www.mja.com.au/journal/2021/cannabidiol-no-better-placebo-low-back-pain ↩

  11. Pramhas S and others. Oral cannabidiol as add-on to paracetamol for painful chronic osteoarthritis of the knee, randomised trial, 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC10682664/ ↩

  12. Narayan AJ and others. Cannabidiol for moderate to severe insomnia, randomised controlled trial of 150 mg nightly, 2024. https://pubmed.ncbi.nlm.nih.gov/38174873/ ↩

  13. 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 ↩

  14. Therapeutic Goods Administration. Consultation hub: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products, updated 21 April 2026. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/ ↩

  15. Therapeutic Goods Administration. Update to the sector on the medicinal cannabis review, July 2026. https://www.tga.gov.au/sites/default/files/2026-07/update-tga-sector.pdf ↩

Common questions

What does SAS-B mean?

It stands for Special Access Scheme Category B. It is the application pathway a prescriber uses to ask the TGA for approval to supply an unapproved medicine to an individual patient. Most applications for cannabis medicines, including CBD oils, use it.

How long does TGA approval take?

The TGA says Category B applications are processed in 2 to 5 days, and may take longer if it needs more information from the prescriber.

Does SAS approval mean the TGA has approved the CBD product?

No. The product stays unapproved, which means the TGA has not assessed it for safety, quality or effectiveness. The approval allows a named prescriber to supply it to a particular patient.

How long does an SAS-B approval last?

For the period stated on the approval letter, as long as the conditions of approval are met. The TGA page does not give a standard length.

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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