TGA — access pathways for medicinal cannabis
The authoritative description of SAS‑B and the Authorised Prescriber Scheme, and where to apply.
tga.gov.auResources
Resources
Regulatory and process information for pharmacists, prescribers and practice staff. No login required.
The chain
From consultation to dispensing.
Five steps, and the approvals that attach to each. Useful for briefing new dispensary or practice staff.
Clinical assessment
The practitioner assesses the patient, considers conventional options and documents the reasoning. Ahpra’s 2025 guidance sets clear expectations here.
Commonwealth approval
The practitioner obtains TGA approval under SAS Category B for that patient, or prescribes under an existing Authorised Prescriber authority.
State or territory approval
Separately required in most jurisdictions for Schedule 8 products. Requirements differ by state — the TGA’s “single‑in” process notifies some, but not all, on the practitioner’s behalf.
Prescription
Written in accordance with the approval and the poisons legislation of the relevant state or territory.
Dispensing
The pharmacy sights and retains the approvals, dispenses, records the Schedule 8 transaction, and counsels the patient.
Primary sources
Primary sources.
Where the requirements are actually set out.
TGA — SAS online system
Where SAS Category B applications are lodged, with current system guidance.
SAS onlineAhpra — medicinal cannabis prescribing guidance
Published July 2025. Sets out professional expectations and the practices Ahpra considers unsafe.
ahpra.gov.auTGA — advertising unapproved therapeutic goods
Why you will not find product information on a public Australian supplier website, including ours.
tga.gov.auFAQs
Questions.
Why can’t I see your products on this website?
Because Australian law does not allow it. The products we supply are unapproved therapeutic goods containing Schedule 4 or Schedule 8 substances, and advertising those to the public is prohibited under the Therapeutic Goods Act 1989 (Cth). Product information is available to verified health professionals through our formulary.
How do I open a pharmacy account?
Either order through one of our four wholesale partners using the account you already hold, or apply for a direct account. Direct applications are usually processed within one business day of a complete application.
Do I need to be an Authorised Prescriber to prescribe an Alma product?
No. You can prescribe under the Special Access Scheme Category B on a per‑patient basis, or apply to become an Authorised Prescriber if you expect to prescribe regularly to a defined patient group. The comparison table sets out the differences.
What dose should I prescribe?
We cannot answer that publicly. Dosing is a clinical decision for the treating practitioner. Verified prescribers can access product documentation and speak with our clinical team through the formulary portal.
Can I get a certificate of analysis for the batch I hold?
Yes. A certificate of analysis is available for every batch we release, searchable by batch number in the portal. If you need one urgently, contact us with the batch number.
How do I report a product quality issue or an adverse event?
Use our reporting form or call us. Please have the batch number to hand. Adverse events should also be reported to the TGA. This is not a channel for clinical advice — if a patient is unwell, treat first.
I’m a patient. Can you help me?
Not directly, and we are not permitted to give you product or clinical advice. Medicinal cannabis in Australia is available only on prescription from an appropriately authorised practitioner. Please speak with your own doctor or nurse practitioner about whether it is appropriate for you.
Do you pay prescribers or clinics for prescribing your products?
No. Alma pays no inducement, commission or benefit to any practitioner or clinic in connection with prescribing. Ahpra has specifically flagged supplier‑prescriber financial arrangements as a conflict‑of‑interest risk.
If something here is unclear, or out of date, tell us.