Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p6
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 14805–17712

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) In determining whether adulteration has occurred, it is irrelevant whether or not the addition or substitution is intended to improve, fortify or debase the medicinal cannabis product or any ingredients used in the manufacture of that product, including, but not limited to, the cannabis plant.

     12 Tests
         (1) The tests mentioned in Schedule 1 are specified with respect to the cannabis plants used in the manufacture of medicinal cannabis products for the purposes of this order.
         (2) The following assay limits are specified for the purposes of this order:
              (a) in relation to a medicinal cannabis product in herbal final form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 80.0 per cent and not more than 120.0 per cent of the stated content of that active ingredient; and
              (b) in relation to a medicinal cannabis product in tablet or capsule form, where that product is not included on the Register – the average content of each active ingredient, together with any corresponding acid, in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient; and
              (c) in relation to a medicinal cannabis product in any other dosage form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient.

              Note: The assay limits specified in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 apply with respect to registered medicinal cannabis products in tablet or capsule form.

13 Manufacturing quality
         (1) This section does not apply to the manufacture of a medicinal cannabis product that is:
          (a) plant material; or
           (b) oil extracted directly from the cannabis plant;
          for use as starting material in the manufacture of another medicinal cannabis product manufactured in accordance with:
              (c) subsections (2) and (3); or
              (d) a licence under Part 3-3 of the Act.
         (2) Each step of manufacture in relation to a medicinal cannabis product that occurs outside Australia must be in accordance with one or more of the following:
              (a) the PIC/S Guide to GMP;
              (b) Article 47 of EU Directive 2003/94/EC;
              (c) Article 47