Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p14
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 14/27)
Character Range: 38229–41263

on the main label

       (1) Subject to the qualifications and special requirements specified in this section and section 10 of this Order, the information on the main label of the 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) if the medicine is contained in an ampoule - a statement of the approved route of administration for the medicine, such as 'inhalation', 'For oral use only' or other phrase, word or abbreviation denoting the approved route(s) of administration.

       (2) The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional information or background text.

       (3) Subject to paragraph (c), the name of the medicine and the name(s) of active ingredient(s) on the main label must:

           (a) appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text either

           (i) immediately below the name of the medicine; or

              (ii) where the trademark of the medicine might be disrupted or obscured, adjacent to the name of the medicine; and
           (b)          not be separated by any text or graphics, except where additional information is:

              (i) required or permitted by:

              (A) paragraph 11(2)(h); or

              (B) subparagraphs 11(2)(i)(i) or 11(2)(i)(ii)(A); or

              (C) subsection 11(5); or

              (ii) in relation to identifying the different formulations of the medicines contained in a composite pack or a medicine kit; and

       (c) if the medicine is:

        (i) supplied in either a small or a medium container; and

        (ii) contains multiple active ingredients

           then, in relation to compliance of the label with paragraph 9(3)(a), the names of the multiple active ingredients and their quantities may be presented together on a continuous line, or lines, of text.

       (4) All text required by this Order to be on the main label must be oriented in the same direction.

       (5) If the medicine contains:

           (a) two or more active ingredients; and

           (b) at least two of those active ingredients belong to any of the following categories:

           (i) a vitamin that is identified by both:

           (A) the approved name of the active ingredient that is a vitamin; and

                  (B) in accordance with subsection 11(5), the word 'vitamin', or any suitable unambiguous abbreviation of the word vitamin, together with the common name of that vitamin; or

           (ii) a mineral; or

              (iii) a herbal preparation that, under subparagraph 11(2)(i)(ii), is required to be quantified as either:

                  (A) the dry or fresh