Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p15
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 38800–41610

proportion of active ingredient(s) must be displayed in a text size of not less than 3.0 millimetres.

       (6) Subject to subsections 9(7) and 9(8), if there are four or more active ingredients in the medicine, the names of each active ingredient, together with its quantity or proportion, may be included on a side panel or side label or on a rear panel or rear label, displayed in a text size of not less than 2.5 millimetres.

       (7) If the medicine is

           (a) either

              (i) for use as an intravenous infusion; or

              (ii) is a haemofiltration or haemodiafiltration solution; and

           (b)  is supplied in a flexible bag container,

       then subsections 9(3) and 9(4) do not apply to the medicine and, where there are eight or more active ingredients in the medicine, subsections 9(5) and 9(6) also do not apply to the medicine.

        (8) For subsection 9(6), where medicines are supplied as part of a composite pack:

           (a) the total number of active ingredients in all of the medicines in the composite pack are to be counted; and

           (b) if the same active ingredient is contained in two or more medicines in the composite pack, each of those active ingredients is to be counted separately;

           for the purposes of determining if subsection 9(6) applies to the composite pack; and

           (c) the required information under subsection 9(6) must be provided separately in relation to the formulation of each medicine in the composite pack.

        (9) Where the name of an active ingredient included in the medicine comprises an ingredient name specified in Schedule 2 to this Order, either alone or in combination with any other descriptors, then the names of all active ingredients in the medicine, together with their quantity or proportion, must be displayed in a text size of not less than 2.5 millimetres.

       (10) Subsection 9(9) does not apply:
           (a) where the medicine is supplied in a small container or a very small container; or
           (b) where the medicine is not supplied in a small container or a very small container and is labelled in accordance with subsection 9(11) and Part 1 of Schedule 2—after 30 April 2026; or
           (c) where the medicine is not supplied in a small container or a very small container and is labelled in accordance with subsection 9(13) and Part 2 of Schedule 2—after 30 April 2028.

       Note: The minimum text sizes for active ingredients on labels of small containers   and very small containers are less than 2.5 millimetres and specified elsewhere in this Order.

       (11) An active ingredient specified in Part 1 of Schedule 2, either alone or in combination with any other descriptors, may be included on the main label of a medicine containing that