Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p29
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 75955–78962

where the medicine for injection is intended for multidose use:

                  (A) where the stated volume in the container is greater than 1 millilitre - as the quantity of the active ingredient in one millilitre of the injection; and

                  (B) the volume in the container is less than or equal to 1 millilitre - as the quantity of the active ingredient in a suitable dose volume of the injection;

              (v) where the medicine for injection is intended for use as a single dose (whether dilution is required or not), and is not intended for electrolyte replacement - as the stated weight of the active ingredient in the stated volume of fill of the injection in the container;

              (vi) where the stated volume of the medicine for injection is 100 millilitres or less, and the medicine is intended for electrolyte replacement - the following:

                  (A) for potassium chloride—as the number of millimoles of potassium chloride in the stated volume of fill of the injection in the container;

                  (B) for all other active ingredients—as the stated weight of each active ingredient in the stated volume of fill of the injection in the container;

           (g) for antibiotic preparations, where potency units are used as a measure of activity - as the number of such units expressed as International Units (IU) established by the World Health Organization;

           (h) for pressurised metered dose inhalers, dry powder inhalers and other metered dose products such as nasal sprays, the quantity of the active ingredient is:

           (i) the quantity delivered per actuation; or

           where the Secretary, when registering the medicine, has accepted that the dose of products containing those active ingredients was clinically established as the metered dose, then:

           (ii) the quantity metered per actuation;

           (i) for preparations applied to the skin and mucous membranes, other than those covered by paragraphs (g) and (h) - as a percentage expressed in terms of w/w, w/v, v/v or v/w, as appropriate, or as the weight or volume in a stated weight or volume of the medicine, as appropriate;

           (j) for the purposes of paragraphs 11(2)(a) – 11(2)(d), for oral preparations that contain active ingredients intended for mineral supplementation, it is sufficient that the quantity or proportion of that active ingredient to be included on a label be expressed as:

           (i) the name of the active ingredient; and

              (ii) the name and quantity of the element intended for mineral supplementation.

           (k) In addition to the requirements of paragraphs 11(2)(a) –11(2)(i), the following requirements apply in the circumstances specified in the following subparagraphs:

              (i) for preparations containing Vitamin A or a derivative of Vitamin A - as the equivalent quantity or proportion of Vitamin A expressed in terms of microgram retinol equivalents;

              (ii)