Document ID: chunk:federal_register_of_legislation:F2021L01582:clause:1_4:p1
Version: federal_register_of_legislation:F2021L01582
Segment Type: clause
Provision Reference: sch 1 cl 4 (pt 1/2)
Character Range: 1676–4718

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) Secretary.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
authorised prescriber authority means an authority under subsection 19(5) of the Act.
Note: Subsection 19(5) of the Act provides that the Secretary may authorise a medical practitioner to supply specified therapeutic goods for use in the treatment of humans, or a specified class of such goods, to a class or classes of recipients specified in the authority.
category 1 means the category of medicinal cannabis product that is a cannabidiol medicinal cannabis product where:
 (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and
 (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and
 (c) the medicine contains no other active ingredients.
category 2 means the category of medicinal cannabis product that is a cannabidiol-dominant medicinal cannabis product where:
 (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and
 (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
 (c) the medicine contains no other active ingredients.
category 3 means the category of medicinal cannabis product that is a balanced medicinal cannabis product where:
 (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and
 (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
 (c) the medicine contains no other active ingredients.
category 4 means the category of medicinal cannabis product that is a tetrahydrocannabinol-dominant medicinal cannabis product where:
 (a) cannabinoids other than cannabidiol (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine; and
 (b) cannabidiol derived from cannabis comprises 2% or more and 40% or less of the total cannabinoid content of the medicine; and
 (c) the medicine contains no other active ingredient.
category 5 means the category of medicinal cannabis product that is a tetrahydrocannabinol medicinal cannabis product where:
 (a) cannabinoids other than cannabidiol (including tetrahydrocannabinol) comprise more than 98% of the total cannabinoid content of the medicine; and
 (b) cannabidiol comprises less than 2% of the total cannabinoid content of the medicine; and
 (c) the medicine contains no other active ingredient.
medicinal cannabis products has the same meaning as in the Regulations.
Regulations means the Therapeutic Goods Regulations