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The Authorised Prescriber scheme explained

An Authorised Prescriber is a doctor with standing TGA authority to prescribe an unapproved medicine to a class of patients. How it works and what it means.

Facts checked 13 November 20266 min readHow we research

An Authorised Prescriber (AP) is a medical practitioner who holds a standing authority from the Therapeutic Goods Administration (TGA) to prescribe a specific unapproved medicine to a class of patients with the same condition.1 Unlike the Special Access Scheme, the doctor does not apply for each patient. For CBD, which is almost always an unapproved medicine, it is one of the two main lawful prescribing routes.2

How is it different from the Special Access Scheme?

Special Access Scheme, Category B Authorised Prescriber
What the TGA approves Supply to one named patient Prescribing to a class of patients with a stated condition
Who can hold it Doctors and other eligible practitioners, including nurse practitioners Medical practitioners only
TGA step for each patient An application, processed in 2 to 5 days None
Reporting Side effects and defects Side effects and defects, plus patient numbers every six months

Source: TGA.13

For the patient, the consultation should be no different. The authority removes a step in the doctor’s paperwork. It does not remove the clinical assessment.

Who can become an Authorised Prescriber?

Only a medical practitioner with general, specialist or limited registration with Ahpra. Provisional, student and non-practising registrants are not eligible, and conditions on a doctor’s registration may affect eligibility.1

The TGA is direct about other professions: “Only registered medical practitioners can become Authorised Prescribers.” Nurse practitioners use the Special Access Scheme.1

The legislation also requires that the doctor has the “qualifications and experience necessary to appropriately manage the medical condition and use the product”.1

How does a doctor get the authority?

There are two routes.1

  • Established history of use. The TGA keeps lists of unapproved medicines it considers to have an established history of use. If the medicine, dosage form and condition are on the list, the doctor applies directly to the TGA. No ethics committee approval or college endorsement is needed.
  • Standard pathway. For anything not on the list, the doctor first needs approval from a human research ethics committee (a body that reviews the ethics of research and unproven treatments) or endorsement from a specialist medical college with relevant expertise. If the doctor intends to treat children, the approval letter must say so.

We could not open the TGA’s current lists to confirm which cannabis medicines, if any CBD-only products, are on them. A prescriber can tell you which route their authority came through.

The TGA says applications “are generally approved within 15 business days”.1

What does the authority cover?

The TGA’s authority letter states:1

  • the class of patients and the specific conditions (indications)
  • what can be prescribed, including the dosage form
  • any conditions on the authority
  • how long it lasts
  • the reporting requirements.

Two limits follow. First, the authority is tied to a particular product type and condition. It is not a general licence to prescribe cannabis medicines for anything. Second, it is personal: “The prescriber named on the TGA authority letter is the only practitioner authorised” to use it.1 Another doctor at the same practice needs their own.

When the authority expires, the doctor must apply again.1 We could not confirm a standard duration, because the TGA page says only that the letter states it.

What must an Authorised Prescriber report?

  • Patient numbers, every six months. For each medicine, the doctor reports how many patients started treatment and how many were treated in total, for the periods January to June and July to December. A report is due even if no patients were treated.1
  • Side effects and defects. Any suspected adverse event or product defect must be reported within 15 calendar days of the doctor learning of it.1

Note what is not reported: the TGA is told how many patients were treated, not who they were or how each one fared. This is one reason Australia has good figures for approvals and units sold but none for the number of patients. The TGA counts approvals and units, not people.4

Can the authority be taken away?

Yes. The TGA says Authorised Prescriber status can be revoked if the doctor does not report patient numbers, if an ethics committee or college withdraws its support, if conditions are breached, if a suitable registered alternative becomes available, or if the TGA becomes aware of significant safety concerns about the product.1

What does the authority not mean?

  • The medicine is still unapproved. The TGA has not assessed it for safety, quality or effectiveness, and the doctor must tell the patient so and obtain informed consent.25
  • It is not a specialist qualification. It is a permission attached to a product and a condition.
  • It does not replace state law. State and territory requirements still apply.3
  • It does not lower the standard of care. The Medical Board expects the same thorough assessment, management plan, follow-up and exit strategy whichever pathway is used, and says medicinal cannabis “should never be a first line treatment”.6

It also says nothing about whether CBD works for a given condition. For many conditions, controlled trials found no benefit over placebo.789 See the conditions section.

Why do regulators watch this pathway closely?

Because it handles large volumes with no check on individual patients. According to the Penington Institute, using TGA figures, Authorised Prescriber approvals and notifications for medicinal cannabis peaked at 428,841 in the first half of 2024 and were 378,136 in the first half of 2025. Special Access Scheme approvals in the first half of 2025 numbered 113,692.4 These figures cover all cannabis medicines, most of which contain THC.

The Medical Board has reported practitioners who each issued more than 10,000 prescriptions in six months, and consultations lasting from “a few seconds” to “a few minutes”.6 Ahpra says it may investigate high-volume prescribers without waiting for a complaint.6 Those concerns, and what a patient can ask, are covered in cannabis clinics and telehealth.

The TGA’s 2025 to 2026 review found broad agreement that the current framework for unapproved cannabis medicines is “not fit-for-purpose”.10 As of November 2026 we found no announced decision to change the scheme.

Is there a list of Authorised Prescribers?

No. There is no public register. The University of Sydney’s Lambert Initiative notes that the TGA does not disclose who is an Authorised Prescriber, for privacy reasons.11 Advertising rules also prevent a business from indicating that it can supply a prescription cannabis medicine.12

A doctor without the authority uses the Special Access Scheme instead, which involves a TGA decision for each patient.3 Which pathway is used is the doctor’s choice, and the same clinical standards apply either way. See who can prescribe CBD and talking to your GP about CBD.

Footnotes

  1. Therapeutic Goods Administration. Access to unapproved therapeutic goods for multiple patients (Authorised Prescriber), updated 23 December 2025. https://www.tga.gov.au/business-services/special-access-scheme-and-authorised-prescriber-online-system/access-unapproved-therapeutic-goods-multiple-patients-authorised-prescriber ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13

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

  3. 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. 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

  5. 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 ↩

  6. Ahpra, Medical Board of Australia and Nursing and Midwifery Board of Australia. Medicinal cannabis prescribing, page reviewed 15 September 2026. https://www.ahpra.gov.au/Resources/Medicinal-cannabis-prescribing.aspx ↩ ↩2 ↩3

  7. 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 ↩

  8. 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/ ↩

  9. 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/ ↩

  10. 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/ ↩

  11. University of Sydney, Lambert Initiative for Cannabinoid Therapeutics. Authorised Prescriber Scheme. https://sydney.edu.au/lambert/how-to-get-medicinal-cannabis/authorised-prescriber-scheme.html ↩

  12. 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 ↩

Common questions

What is an Authorised Prescriber?

A medical practitioner who holds a TGA authority to prescribe a particular unapproved medicine, in a stated dosage form, for a stated condition, to patients in their care. They do not need a separate TGA approval for each patient.

Is an Authorised Prescriber better qualified than other doctors?

Not necessarily. The authority is a regulatory permission, not a specialist qualification. The TGA requires that the doctor has the qualifications and experience to manage the condition and use the product, as it does for any pathway.

Is there a list of Authorised Prescribers?

No. The TGA does not publish the names of Authorised Prescribers, and advertising rules stop businesses from indicating that they can supply prescription cannabis medicines.

Does it make a difference to me which pathway my doctor uses?

Mostly it affects the doctor's paperwork. An Authorised Prescriber does not apply to the TGA for each patient. The assessment, informed consent, follow-up and cost should be the same.

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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