Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p13
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 13/27)
Character Range: 35294–38479

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, additional warning or advisory statements).

           (e) If information other than the critical health information or information of a kind mentioned in subsections 8(2)(c) or 8(2)(d) is to be included, it must be placed under the 'Other information' heading or under another separate appropriate heading(s) that follow immediately below the headings mentioned in 8(2)(b) and must not contain any additional information other than:
                   1.                  requirements relating to storage conditions
                   2.                   information about package features to prevent tampering
                   3.                   names of all excipients
                   4.                  sponsor or distributor contact details.

       (f) The presentation of the critical health information, and any information mentioned in paragraphs 8(2)(c), 8(2)(d) or 8(2)(e) that is included, must be presented in black or other dark coloured texts, using only one colour, on a white or other contrasting background.

    (3) If the medicine is registered goods and

       (a) both:

              (i) the medicine is a medicated throat lozenge or an inorganic salt-based antacid that is in a solid dosage; and

              (ii) the space available for a label on the primary pack is less than seventy square centimetres;

       or

              (iii) the medicine is intended for use as a skin antiseptic:

              (A) for hand-hygiene; or

              (B) by a health professional as a patient pre-operative preparation; or

           (iv) the medicine is a paste or gel for the cleaning of teeth,

       then subsection 8(2) does not apply.

       (4) If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging 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 batch number of the medicine preceded by the batch number prefix; and

           (e) the expiry date of the medicine preceded by the expiry date prefix; and

           (f) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.

       (5) If the container is enclosed in a delivery device such that it cannot be removed, the information required on its label under subsection 8(1) must be applied on the delivery device and not the container.

       9 Information to be included 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