Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p11
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 11/27)
Character Range: 29655–32724

or distributor of the medicine; and

           (j) where:

              (i) a substance or substance within the group of substances referred to in Column 1 of Schedule 1 to this Order is present in the medicine;

              (ii) the circumstances as set out in Column 2 of Schedule 1 exist in relation to such a substance or no circumstances are set out in Column 2; and
              (iii)       the medicine is intended to be administered via any one or more of the route(s) of administration referred to in Column 3 of Schedule 1,

           then:
              (iv)        a statement:

                  (A)        indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; and

                  (B)        where any of the circumstances and requirements set out in Column 2 of Schedule 1 exist in relation to the substance – a statement of the kind referred to as a 'requirement' in that Column (if any); and
           (k) relevant warning statements, where these are required in relation to a particular medicine or in specified circumstances applying to a particular medicine, such as the following:

              (i)  where the medicine is for external use the required statement is 'Caution: Not to be Swallowed' or 'For External Use Only' or words to this effect;

              (ii) where:
                   (A)        the medicine is for oral use; and
                   (B)        the medicine contains active ingredient(s) included in category 'B' (including 'B1', 'B2, 'B3') or category 'C' in the document titled 'Prescribing medicines in pregnancy database' published on the TGA website as on the date of commencement of this Order; and
                   (C)        the medicine is not subject to other specific warning statement(s) relating to use during pregnancy,
              the required statement is: 'If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use' or words to this effect; and

              (iii) where:
                   (A)        the medicine is a registered goods for oral use; and
                   (B)        the medicine contains active ingredient(s) included in category 'D' (except nicotine for smoking cessation) in the document titled 'Prescribing medicines in pregnancy database' published on the TGA website as at the date of commencement of this Order; and
                   (C)        the medicine is not subject to other specific warning statements(s) relating to use during pregnancy,
              the required statement is 'Do not use this medicine if pregnant or likely to become pregnant' or words to this effect; and

           (l) directions for use of the medicine except where:

              (i) the dose of the medicine is usually determined for each individual patient 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