Product Registration

Workflow steps

1. Product Defined
   Medicinal cannabis product defined. Australia has two main pathways: full ARTG registration or unregistered access via Special Access Scheme (SAS) or Authorised Prescriber (AP).
2. ARTG or Unregistered?
   Full ARTG registration provides commercial-scale supply but requires substantial investment. SAS/AP allows market entry with less upfront cost but on a patient-by-patient or prescriber basis.
3. ARTG Registration — Full registration
   Full TGA registration provides unlimited commercial supply. Required for Schedule 4 (Prescription Only) listing. Epidyolex is the only fully registered cannabis product as of 2026.
   • Full CTD dossier (Modules 1–5)
   • Clinical evidence of efficacy and safety
   • TGA evaluation fee ~$80,000–$250,000+
   • 12–24 month evaluation timeline
4. Authorised Prescriber (AP) — Preferred scale pathway
   TGA grants a specific prescriber ongoing authority to prescribe a specific unregistered product for a specific indication. No per-patient TGA approval needed once AP status granted.
   • Prescriber applies to TGA with clinical justification
   • Ethics committee support may strengthen application
   • AP status is product and indication specific
   • Approved prescriber can treat multiple patients
5. SAS Category B — Per-patient access
   Prescriber submits individual patient application to TGA. Approved per patient. Most common pathway for new products entering Australia.
   • Prescriber submits SAS-B form per patient
   • TGA approves within ~48 hours for most applications
   • No volume limit but must re-apply per new patient
   • Sponsor must hold ODC and TGA licenses
6. Prepare Dossier & Sponsor
   For ARTG: full CTD dossier. An Australian sponsor must be named on the ARTG — overseas manufacturers must appoint an Australian entity.
   • Australian sponsor entity required
   • Sponsor holds TGA and ODC licenses
   • Full CMC data, stability, clinical evidence
7. TGA Evaluation
   TGA evaluates the full dossier. May issue questions at Day 45, 90, and 180 of the 255-working-day evaluation clock.
   • Respond to TGA questions within specified timeframes
   • Clinical Advisory Committee review for novel indications
8. ARTG Registration Granted ✓
   Product registered. Can be supplied commercially at scale. Schedule 4 listing enables broad pharmacy dispensing.
9. SAS/AP Supply Active ✓
   Ongoing supply via AP prescribers or individual SAS-B applications. No formulary listing but no per-patient TGA barrier for AP prescribers.