Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p3
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 6022–9300

the following form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', 'EXP', 'Use by' or 'Use before' or words to this effect, including a mixture of lower and upper case letters;
              (c) is not in the following form: 'Best by' or 'Best before' or words to this effect.

         licensing authority means a body empowered to issue a certificate or other document to the effect that the body is satisfied that a manufacturing site complies with requirements for good manufacturing practice of therapeutic goods.

         medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of the cannabis plant.

         Medsafe means the New Zealand Medicines and Medical Devices Safety Authority within the New Zealand Ministry of Health.

         New Zealand Code of GMP means the document New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, published by Medsafe, as in force or existing from time to time.

         PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.

         PIC/S Guide to GMP means the document Guide to Good Manufacturing Practice for Medicinal Products (PE 009-15, 1 May 2021) published by PIC/S, as in force or existing from time to time, and includes the Annexes to that document other than the following:
              (a)                     Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);
              (b)                    Annex 5 (Manufacture of immunological veterinary medical products);
              (c)                     Annex 14 (Manufacture of medicinal products derived from human blood or plasma).

         plant material means dried or fresh material of the cannabis plant that has not undergone any refinement, including dried flos.

              Note: Refinement does not include cutting or grinding material of the cannabis plant.

         plant preparation means material of the cannabis plant that has undergone some refinement, excluding material of the cannabis plant that has been refined to a single cannabinoid.

              Note: Refinement does not include cutting or grinding material of the cannabis plant.

         processing aid means a substance used in the manufacture of a medicinal cannabis product that is not intended to remain in the final formulation of the product (although trace amounts may remain in the product).

         quantity of the medicinal cannabis product means:
             (a) where the medicinal cannabis product consists of discrete dosage units, such as tablets or capsules or sachets—the stated number of units in the container;
             (b) where the medicinal cannabis product is:
                (i) a solid or semi-solid—the stated weight in the container;
                (ii) a liquid—the stated volume of fill in 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