Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p16
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 16/27)
Character Range: 43506–46427

in subparagraphs 9(7)(a)(i) and (ii) do not apply to the main label on the primary pack;
           (b)         where the medicine contains four or more active ingredients and subsection 8(2) does not apply, then the names and the quantities or proportions of the active ingredients may be included on a side panel or side label or on a rear panel or rear label, when displayed in a text size of not less than 2.5 millimetres; or

           (c) where the medicine contains four or more active ingredients and subsection 8(2) applies, then compliance with paragraphs 9(1)(b) and 9(1)(c) is not required; or

           (d) if subsection 8(2) applies and the medicine:

              (i) includes one or more active ingredients, the name of which includes descriptors (for example chemical salts or hydration states) that are not therapeutically relevant; and

              (ii) the name and quantity or proportion of each of those active ingredients is displayed in accordance with subsection 8(2),

           then the name of the therapeutically active moiety(ies) of the active ingredient may be displayed on the main label on the primary pack, instead of the name of the active ingredient, if:
              (iii)       this is in a text size of not less than 3.0 millimetres; and
              (iv)        no quantity or proportion information is displayed for any of the active ingredients in the medicine.

       (8) Where a medicine is:
           (a)          supplied as part of either a composite pack or a medicine kit; and
           (b)         there are different formulations of medicine in that composite pack or medicine kit;
           (c)          (i) the total number of active ingredients in the different formulations in the composite pack or medicine kit are to be counted; and

           (ii) if the same active ingredient is contained in two or more formulations in the composite pack or medicine kit, each of those active ingredients is to be counted separately,

           for the purposes of determining if paragraph 9(6)(b) applies to the composite pack or medicine kit, or which paragraph in subsection 9(7) applies to the composite pack or medicine kit; and

           (d) the information required under either paragraph 9(6)(b) or subsection 9(7) must be provided separately in relation to each formulation of medicine in the composite pack or medicine kit.

       (9) If the medicine is intended to be, or is, registered goods, and 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