Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
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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 a medicinal cannabis product that is plant material—all of the following:
(i) the minimum dry weight or minimum fresh weight of plant material (including the word ‘minimum’);
(ii) the plant species;
(iii) the plant part;
Example: “Cannabis sativa flower dry 500 mg minimum, containing THC 30 mg”.
(i) the dosage form of the medicinal cannabis product;
(j) the quantity of the medicinal cannabis product.
(3) The label of a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient must state the name and quantity of each active ingredient that is purported to be present in the medicinal cannabis product.
(4) All of the information that is displayed on the label of a medicinal cannabis product must be:
(a) in English; and
(b) legible; and
(c) visible and not obscured; and
(d) durable.