- TGA — Therapeutic Goods Administration
Federal medicines regulator. Manages ARTG registration, GMP licensing, import permits, and Special Access Scheme. Falls under the Department of Health.
- ARTG product registration
- GMP clearance for manufacturers
- Per-shipment import permits
- SAS and Authorised Prescriber approvals
- ODC — Office of Drug Control
Issues narcotic licenses and permits under the Narcotic Drugs Act 1967. Separate from TGA — both agencies must approve imports.
- Annual narcotic licenses (manufacturer, importer, distributor)
- Per-shipment import and export permits
- Secure storage compliance audits
- Department of Health — Federal oversight
Policy oversight of both TGA and ODC. Sets national medicinal cannabis policy framework. Coordinates international treaty obligations under Single Convention 1961.
- NSW: HPCA — Health Professional Councils
NSW oversees prescriber standards. Standard enforcement for Schedule 8 (NSW). Prescribers must notify NSW Ministry of Health for Schedule 8 prescriptions beyond standard thresholds.
- Victoria: DHHS — Department of Health
Victorian prescribers may need Department of Health approval for Schedule 8 prescribing. Victoria has its own state narcotic policy layer above federal TGA/ODC requirements.
- QLD: Queensland Health — Authority to Prescribe (ATP)
Queensland requires an Authority to Prescribe (ATP) for Schedule 8 cannabis from Queensland Health for non-AP prescribers. Additional state layer beyond TGA SAS.
- WA / SA / TAS / ACT / NT — Other state/territory authorities
Each state and territory has its own Schedule 8 oversight body. Requirements vary — some require state approval in addition to TGA SAS. Always verify state-level requirements.
- Pharmacies & Hospitals — Dispensing
Dispense against valid Schedule 8 prescriptions. Must hold state pharmacy license. Maintain Schedule 8 register. Report to state health authority.
- Schedule 8 register maintained
- State pharmacy license
- Dispensing records retained 7 years