Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p10
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 10/27)
Character Range: 26948–29917

of Schedule 10 to the Therapeutic Goods Regulations 1990

           (b) any warning statements specified in any standard that applies to the medicine;
           (c) any warning statements required by the Secretary to be included on the label as a condition of registration or listing in relation to the medicine;
           (d) any warning statement required in relation to an ingredient being contained in a medicine as specified a determination made by the Minister under subsection 26BB(1)(b) of the Act; and
           (e) any warning statements specified in the Poisons Standard.

       7 General requirements, including label presentation

       (1) The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine.

       (2) The information required by this Order to be included on a label or labels must:

       (a) be clearly visible and not be obscured; and

       (b) be in English; and

       (c) be in durable and legible characters; and

           (d) unless otherwise specified elsewhere in this Order, be displayed in a text size of not less than 1.5 millimetres, except:

              (i) in the case of the registration number or listing number, which must be in a text size of not less than 1.0 millimetre height as required by subparagraphs 15(1)(c)(i) and (ii), respectively of the Regulations; and

           (e) be in a colour or colours contrasting strongly with the background, except for:

              (i) the expiry date and expiry date prefix; and

              (ii) the batch number and batch number prefix

              when that information is embossed or debossed and not printed;  and

           (f) unless otherwise specified elsewhere in this Order, be in metric units of measurement.

       8 Information to be included on the label

       (1) Subject to the qualifications and requirements specified in subsections 8(2) and 8(3) and sections 9 and 10 below, the labels of a 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) the batch number of the medicine preceded by the batch number prefix; and

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

           (h) the storage conditions applicable to the medicine; and
       (i) the name and contact details of the sponsor 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