Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p5
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 11725–15078

w/v of the product; and
              (b) any other cannabinoid present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 2.0% w/w or w/v of the product.

     5 Standard
         This order constitutes a standard for medicinal cannabis products.

     6 Application
         (1) Subject to subsection (2), this order applies to:
              (a) medicinal cannabis products; and
              (b) any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant.
         (2) This order does not apply to medicinal cannabis products that are:
              (a) export only medicines; or
              (b) mentioned in item 1 of Schedule 5 to the Regulations; or
              (c) mentioned in items 4, 8, 10, 11 or 12 of Schedule 5A to the Regulations, subject to compliance with the conditions specified in those items.

     7 Monograph
           The standard constituted by the statements in the monograph titled Pharmaceutical Preparations (2619) in the European Pharmacopoeia applies with respect to:
              (a) medicinal cannabis products; and
              (b) any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant;
          but does not apply to the extent of any inconsistency with this order.

              Note: The Pharmaceutical Preparations (2619) monograph incorporates applicable requirements contained in other monographs that also need to be complied with, for example Herbal Drugs (1433).

     8 Active ingredients and cannabinoids
          Each active ingredient and any other cannabinoid (that is not an active ingredient) in a medicinal cannabis product must comply with the following:
              (a) the active ingredient or other cannabinoid must be from the cannabis plant; and
              (b) the chemical structure of the active ingredient or other cannabinoid must not be modified or transformed in any way (including by chemical or other means).

                  Note: Modification or transformation does not include decarboxylation of naturally occurring acid forms of cannabinoids.

     9 Decontamination
          Any decontaminating treatment of the cannabis plant used in the manufacture of medicinal cannabis products must not:
              (a) adversely affect the quality of medicinal cannabis products; or
              (b) make use of, or otherwise contain, ethylene oxide.

     10 Identification
          The cannabis plants used in the manufacture of medicinal cannabis products must be positively identified using each of the following identification methods:
              (a) macroscopic examination; and
              (b) microscopic examination; and
              (c) chromatographic procedures.

     11 Adulteration
         (1) Medicinal cannabis products and any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant, must not contain any substance that results in the adulteration of those products or ingredients.
         (2) For the purposes of subsection (1), adulteration includes the addition of, or substitution with, any substance that is extraneous to the formulation of the product, other than a processing aid.
         (3)