Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p11
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
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Character Range: 28159–31155

of the most commonly prescribed pharmaceutical benefits quantity or of the smallest trade pack, whichever is relevant, the smallest trade pack for the medicine;
       supply has the same meaning as in the Act;
       text size means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated;

       very small container means a container having a capacity less than or equal to 3.0 millilitres;

       warning statements means:
           (a) any warning statements specified in any standard that applies to the medicine;
           (b) any warning statements required by the Secretary to be included on the label as a condition of registration in relation to the medicine; and
           (c) any warning statements specified in the Poisons Standard.

       7 General requirements, including label presentation

       (1) The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine.

       (2) The information required by this Order to be included on a label or labels must:

       (a) be clearly visible and not be obscured; and

       (b) be in English; and

       (c) be in durable and legible characters; and

           (d) unless otherwise specified elsewhere in this Order, be displayed in text size of not less than 1.5 millimetres, except

              (i) in the case of the registration number, which must be in a text size of not less than 1.0 millimetre height as required by subparagraph 15(1)(c)(i) of the Regulations; and

           (e) be in a colour or colours contrasting strongly with the background, except for:

              (i) the expiry date and expiry date prefix; and

           (ii) the batch number and batch number prefix

           when that information is embossed or debossed and not printed; and

           (f) unless otherwise specified elsewhere in this Order, be in metric units of measurement.

       8 Information to be included on the label

       (1) Subject to the qualifications and requirements specified in sections 9 and 10 below, the labels of a medicine must include:

           (a) the name of the medicine; and

       (b) the name(s) of all active ingredients in the medicine; and

       (c) the quantity or proportion of all active ingredients in the medicine; and

       (d) the name of the dosage form; and

       (e) the quantity of the medicine; and

       (f) the batch number of the medicine preceded by the batch number prefix; and

           (g) the expiry date of the medicine, preceded by the expiry date prefix; and

           (h) the storage conditions applicable to the medicine; and

           (i) the name and contact details of the sponsor or distributor of the medicine; and

           (j) where:

              (i) a substance or substance within the group of substances