Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p4
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 8967–11973

the container;
                (iii) a pressurised metered-dose preparation or dry powder inhaler—the stated number of deliverable doses in the container;
                (iv) a non-pressurised metered dose preparation—the minimum number of deliverable doses in the container;
             (c) where the medicinal cannabis product is a product of any of the kinds referred to in paragraph (b) and the product consists of a number of identical containers within the primary pack—the number of containers (for example, 5 x 10 mL vials);
             (d) for each of the individual containers within the primary pack, the quantity of the medicinal cannabis product to be included on the individual container label would be as described in paragraph (b) (for example, the stated volume of fill in the container).

         Regulations means the Therapeutic Goods Regulations 1990.

         South African Guide to GMP means the document 4.01 - South African Guide to GMP (July 2019, V7), published by the South African Health Products Regulatory Authority, as in force or existing from time to time.

         stated content, in relation to each active ingredient in a medicinal cannabis product, means the quantity or proportion of each active ingredient that is:
              (a) specified on the label to be present in the medicinal cannabis product in accordance with any decision made by the Secretary under section 25 of the Act in relation to that product; or
              (b) disclosed to the Secretary in an application under section 19 of the Act for an approval or authority in relation to the medicinal cannabis product; or
              (c) disclosed to the Secretary in a notification under regulation 12A of the Regulations; or
              (d) purported to be present in a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient; or
              (e) notified to be present in a medicinal cannabis product for the purposes of item 3 of Schedule 5A to the Regulations.

         TGO 95 means the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

         Therapeutic Goods Administration has the same meaning as in the Regulations.
         (2) Without limiting the meaning of active ingredient in subsection (1), the following substances are taken to be active ingredients for the purposes of this order (whether or not those ingredients are specified, disclosed, purported or notified to the Secretary to be active ingredients):
              (a) any tetrahydrocannabinol present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 1.0% w/w or 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.

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