Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p19
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 49159–52060

with sections 8 and 9 and subsection 10(3)

       then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3), it shall be sufficient if the following information is displayed in a text size of not less than 2.0 millimetres:

           (c) the name of the medicine; and

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

       and the following information is displayed in a text size of not less than 1.5 millimetres:

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

           (f) the name of the dosage form; and

           (g) the quantity of the medicine; and

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

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

           (j) the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine; and

           (k) the approved route of administration for the medicine, such as 'intravenous', 'intramuscular' or 'subcutaneous' or other phrase, word or abbreviation denoting the approved route(s) of administration; and

           (l) where the medicine is an injection containing iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and

           (m) where the medicine is intended for electrolyte replacement and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:

              (i) for potassium chloride, and unless precluded by the container size—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and

              (ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).

        1.          Injections in a container with a capacity of 3.0 millilitres or less

           If a medicine is an injection that:

           (a) is in a container with a capacity of 3.0 millilitres or less; and

           (b) the container is enclosed in a primary pack, the label of which complies with the sections 8 and 9 and subsection 10(3)

       then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3),  it shall be sufficient if:

           (c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres; and

           the following information is displayed in a text size of not less than 1.0 millimetre:

           (d) the quantity of the medicine; and

       (e) the batch number of the medicine preceded by the