Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p12
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 12/27)
Character Range: 32486–35588

by a health professional authorised under a law of a State or Territory to determine the dose; or

              (ii) there is insufficient space on the label of either the container or the primary pack, or both, to include directions for use, and:
                 (A)  those directions for use are set out in a package insert provided in the primary pack of the medicine; and
                 (B)  a statement is included on whichever label on the container, or the primary pack, or both, that does not set out the directions for use itself, that those directions are set out in the package insert; and

           (m) if the medicine requires some preparation, such as dissolving, suspending, diluting or reconstituting before use - instructions for its preparation and, where relevant, a statement of the conditions of storage and the maximum period of storage between preparation and use, except where:

              (i) there is insufficient space on the label of either the container or the primary pack, or both, to include this information; and

              (ii) this information is set out in a package insert provided in the primary pack of the medicine; and

              (iii) a statement is included on whichever label on the container or the primary pack, or both, that does not set out the information itself, that this information is set out in the package insert; and

           (n) a statement of the purpose or purposes for which it is intended that the medicine be used, except where:

              (i) the medicine is:
                  (A)          supplied solely to a complementary healthcare practitioner for supply to a person after affixing by the practitioner of an instruction label on the medicine following a consultation with that person; and
                  (B)          the label of the medicine includes the words 'For Practitioner Dispensing Only'; and

           (o) 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) (a) Subject to paragraphs (b), (c) and (d), where the medicine is registered goods, the critical health information must be displayed on the label of the primary pack in a tabulated form.

           (b) The critical health information must be presented under appropriate headings and in the following order:
              (i)           Active ingredients
              (ii)         Indications
              (iii)       Warnings
              (iv)       Directions for use
              (v)         Other information.

       (c) The information provided under paragraph 8(2)(b)(i) may include words describing the purpose of the active ingredient(s) by indicating the pharmacological category or the principal intended actions that are not required by this Order.

       (d) The information provided under paragraph 8(2)(b)(iii) may include safety related information not required by this Order (such as allergen advice, caution,