Regulations
Regulations
Each Australian State and Territory has varying requirements for patients depending upon the classification of medical cannabis.
Schedule 8
Doctor must receive a SAS-A or SAS-B approval certificate from TGA prior to making a separate application to the relevant state Health Department. S8 products contain greater than 2% THC proportion of total cannabinoid.
Schedule 3 / 4
No State Health Department approvals required. S4 products contain less than 2% of the total cannabinoid content as THC, or with 98% or more as CBD.
*Effective 1 February 2021, TGA has approved the reclassification of CBD to Schedule 3 for ARTG registered products (<150mg per day, excluding Vapes & creams). This amendment now allows patients to purchase CBD products for therapeutic use upon consultation with a pharmacist, without the need for a prescription.
Once TGA SAS and State Health Department approval is received, a doctor will provide the patient with;
a) A copy of the patients TGA approval (containing a unique code)
b) A prescription including;
- Patient’s TGA approval code
- Doctor’s contact number
- Titration schedule for the specific product.
In order to dispense products, a Pharmacist must obtain the original prescription and copies of TGA and relevant State Health approvals for medical cannabis.
Unapproved medicines cannot be stocked without a TGA approval and a prescription, so medicinal cannabis products can only be ordered once these are obtained.
Doctors who are Authorised Prescribers, may fast track the process by sending these documents directly to a Pharmacist or Wholesaler.
Wholesalers can only release prescribed product(s) upon receipt of a copy of the TGA and relevant health department approval(s). Products can then be shipped a pharmacist who can dispense to the patient.
When dispensing medications, it is a requirement that any event (including adverse events) be reported to the TGA and the product’s supplier within 15 days.
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