Australian Schedule 3 Pathways

Australian Schedule 3 CBD ARTG Registration

The below proposal to amend the Schedule 4 cannabidiol to Schedule 3 has been outlined in a Public Notice.

Cannabidiol in oral, oral mucosal and sublingual formulations preparations for therapeutic use when:

  1. The cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer
  2. The maximum recommended daily dose is 60 mg or less of cannabidiol
  3. In packs containing not more than 30 days’ supply
  4. Cannabidiol comprises 98% or more of the total cannabinoid content of the preparation
  5. Any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation
  6. For adults aged 18 years and over
  7. Packed in blister or strip packaging or in a container fitted with a child-resistant closure

MCRC are well equipped to conduct your Quality, Safety and Efficacy research requirements in order to register your CBD product for its single medical indication

Popular clinical trial pathways that MCRC are well versed and experienced with are:

  • 1Trial
    Design
  • 2Writing
    Protocol
  • 3Ethics
    Submission
  • 4Ethics
    Committee
  • 5Trial
    Registration
  • 6CTN
    Application
  • 7Import
    Permit
  • 8TGA
    Sponsorship
  • 9Customs
    Broking
  • 10Freight
    Forwarding
  • 11Creation of
    Consent Form
  • 12Research Nurse/
    Liaison Contracting
  • 13Medical Prescriber
    Consults
  • 14SAS
    Approvals
  • 15Pharmacy
    Dispensing
  • 16Trial
    Insurance
  • 17Publication Submission,
    Follow up and RFLs
  • 18Discussion
    Write Up
  • 19Results
    Analysis
  • 20Patient Follow
    up Consults