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Scheduling delegate's final decisions: Cannabis and Tetrahydrocannabinols, March 2016

Scheduling medicines and poisons

31 August 2016

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Part B - Final decision on matters not referred to an expert advisory committee

Summary of delegate's final decision
Substance Final decision
Nabiximols

Schedule 8 - Amend Entry

NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.

Implementation date: 1 November 2016

2.1 Nabiximols

Delegate's Scheduling proposal

The delegate considered amending the Schedule 8 nabiximols entry to ensure consistency in the context of the changes made in relation to the scheduling decision changes for cannabis and tetrahydrocannabinols.

Current scheduling status

The current Schedule 8 entry for Nabiximols is as follows:

# NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors[4];
  • Other relevant information.
Delegate's final decision

The final decision is to amend the Schedule 8 entry for nabiximols.

This decision was an editorial amendment to clarify that the nabiximols entry used the correct terminology for tetrahydrocannabinols by adding an 's' to tetrahydrocannabinol.

The reasons given by the delegate comprised the following:

  • To ensure consistency with the scheduling decisions for cannabis and tetrahydrocannabinols.

The implementation date is 1 November 2016.

Schedule entry
Schedule 8 - Amend Entry

# NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

Book pagination