Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p8
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 20330–23707

New Zealand—one of the following:
                   (i)                  a valid Licence to Manufacture Medicines issued under the Medicines Act 1981 (NZ), as in force or existing from time to time;
                   (ii)               a valid certificate of good manufacturing practice issued to the manufacturer of the product by Medsafe;
                   (iii)             written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP;
              (f) for a medicinal cannabis product manufactured in any other country—written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP.
         (4) A certificate, licence or written confirmation mentioned in subsection (3) must:
              (a) cover the relevant medicinal cannabis product; and
              (b) relate to each manufacturing site where the medicinal cannabis product was manufactured; and
              (c) have been current at the time the medicinal cannabis product was manufactured.

     14 Child-resistant packaging
         (1)  This section does not apply to a medicinal cannabis product that is:
              (a) plant material; or
              (b) mentioned in section 7 of TGO 95.
         (2) A medicinal cannabis product must comply with the requirements specified in the following sections of TGO 95:
              (a) section 8 (general requirements); and
              (b) where the product is in a reclosable package—section 9 (reclosable packages); and
              (c) where the product is in a non-reclosable package—section 10 (non-reclosable packages.

     15 Labels
         (1) A medicinal cannabis product that is a finished product must be labelled in accordance with this section.
         (2) The label of a medicinal cannabis product, other than a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient, must contain all the following information:
              (a) the name of the medicinal cannabis product;
              (b) the name and contact details of the sponsor of the medicinal cannabis product;
              (c) the storage conditions applicable to the medicinal cannabis product;
              (d) the batch number of the medicinal cannabis product preceded by the batch number prefix;
              (e) the expiry date of the medicinal cannabis product preceded by the expiry date prefix;
              (f) the name of each active ingredient of the medicinal cannabis product, and the quantity of each active ingredient (including appropriate units);
              (g) for each active ingredient of a medicinal cannabis product that is a plant preparation—all of the following:
                   (i) the weight of the plant preparation, and the minimum dry weight of fresh weight of the plant material from which it was prepared (including the word minimum), except where the plant preparation is an oil;
                   (ii) the plant species;
                   (iii) the plant part;
                   (iv) the preparation type;

                   Example: "Cannabis sativa leaf dry extract 5 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing THC 30 mg".
              (h) for each active ingredient of