Legal Regulation of Cannabinoid Medicine

Legal Compliance

Medical Cannabis Clinic works diligently to comply with Australian Legal Regulations regarding cannabis as a medical treatment.

MCCA CBD Oil is of the highest pharmaceutical grade quality, unlike that of crude oil compounds, MCCA CBD oil is approved for human consumption.

Legal Regulations

Medication and Poisons are scheduled by the Therapeutic Goods Administration (TGA) according to their level of perceived benefit/harm. Every classification is outlined in The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which is registered on the Federal Register of Legislative Instruments as the Poisons Standard.

Up until recently Cannabis and all its constituents have been scheduled as a Prohibited Substance in Schedule 9:

CANNABIS except:

  1. when separately specified in these Schedules; or
  2. processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinol and products manufactured from such fibre.

TETRAHYDROCANNABINOLS and their alkyl homologues except:

  1. when separately specified in this Schedule;
  2. when included in Schedule 8;
  3. in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with a warning statement:
    • Not for internal use; or
    • Not to be taken; or
  4. in products for purposes other than internal human use containing 50 mg/kg or less of tetrahydrocannabinols.

After much review, in March 2015, the TGA decided to amend the SUSMP.

Delegate’s final decision:
The delegate has amended the scheduling entry from that published in the interim decision after further consultation with the jurisdictions to ensure clarity in the entry. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Scheduling Entry

Schedule 4 – New Entry

  • CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis

Schedule 9 – Amend entry

TETRAHYDROCANNABINOLS and their alkyl homologues except:

  1. when separately specified in this Schedule;
  2. when included in Schedule 4 or Schedule 8;
  3. in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with a warning statement:
    • Not for internal use; or
    • Not to be taken; or
  4. in products for purposes other than internal human use containing 50 mg/kg or less of tetrahydrocannabinols.

The TGA stated the following reasons for the Change in scheduling:

The reasons for the recommendation comprised the following:

  • The condition that cannabidiol treats (the therapeutic use) requires diagnosis, management and monitoring under an appropriate medical practitioner.
  • Cannabidiol has a safety profile which is consistent with a Schedule 4 listing.
  • There is low risk of misuse or abuse as cannabidiol does not possess psychoactive properties.
  • The schedule entry needs to acknowledge that there is no pure form of cannabidiol currently available. However, low levels of impurities found in some cannabidiol products are not clinically significant and the scheduling entry should reflect this by allowing cannabinoids, up to 2 %.
  • The entry allows for but does not specify any particular non-active cannabis impurity/ies to be within the up to 2%.
  • The substances that comprise the up to 2% must be substances found in cannabis. They cannot be synthetic cannabinoids.
  • The entry does not preclude the cannabidiol and/or any other cannabinoids being derived from natural sources or made artificially, consistent with the interpretation of the schedules.
  • Appendix D is not supported as the criteria are not met. It is considered that it is the medical condition for which CBD may be used which requires treatment by a specialist. Cannabidiol, itself has no particular attributes that requires it to be included in Appendix D. Scope of practice will ensure the appropriate prescribing of cannabidiol rather than scheduling.

For the full information on the interim decision please follow this link: