Note: A number of expressions used in this order are defined in subsection 3(1) of the Act, including the following:
(a) batch;
(b) British Pharmacopoeia;
(c) container;
(d) European Pharmacopoeia;
(e) export only medicine;
(f) label;
(g) manufacture;
(h) Register;
(i) sponsor;
(j) standard;
(k) therapeutic goods;
(l) United States Pharmacopeia–National Formulary.
(1) In this order:
acceptance criteria, in relation to microbiological quality, are interpreted as:
(a) 101 CFU: maximum acceptable count is 20;
(b) 102 CFU: maximum acceptable count is 200;
(c) 103 CFU: maximum acceptable count is 2000, and so forth.
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of a medicinal cannabis product, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution.
batch number prefix means the prefix which precedes the batch number and has the following characteristics:
(a) clearly indicates that the information following the prefix is the batch number; and
(b) is in the following form: ‘BATCH NUMBER’, ‘BATCH NO.’, ‘BATCH’, ‘B’, ‘(B)’, ‘B/N’, ‘LOT NUMBER’, ‘LOT NO.’, or ‘LOT’, or words or symbols to this effect, including a mixture of lower and upper case letters.
cannabis plant means any plant, or part of a plant, of the genus Cannabis, including, but not limited to, the flowers, fruiting tops, seeds, stems and leaves of the plant.
Note: Subspecies of the cannabis plant, Cannabis sativa, include Cannabis sativa subsp. sativa, Cannabis sativa subsp ruderalis and Cannabis sativa subsp. indica.
EU Member State means a member state of the European Union.
EU Directive 2001/83/EC means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as in force or existing from time to time.
EU Directive 2003/94/EC means Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as in force or existing at 28 March 2022.
excipient, for a medicinal cannabis product, means an ingredient that is not an active ingredient.
expiry date has the same meaning as in the Regulations.
expiry date prefix means a prefix which precedes the expiry date and has the following characteristics:
(a) clearly indicates that the information following the prefix is the expiry date;
(b) is in 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 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.
Section 4 - Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 - Interpretation | Zoe