Document ID: chunk:federal_register_of_legislation:F2019L01013:clause:1_2
Version: federal_register_of_legislation:F2019L01013
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 1978–3717

2  Section 4 (definition of health warning)
Repeal the definition, substitute:
health warning means:
          (a)    in relation to a medicine that contains an ingredient mentioned in column 1 of an item in a table in Schedule 1, in the circumstances set out in column 2 of that item―the statement mentioned in column 3 of that item;
          (b)   in relation to a medical device or other therapeutic goods―a statement that is required under the Act, Regulations or Medical Devices Regulations to be included on the label, or in the instructions for use, of the device or goods, and is to the effect that:
               (i) a person who takes, or uses, the device or goods as intended may:
                 (A) die; or
                 (B) require hospitalisation or a longer period of hospitalisation than would be required if the person had not taken, or used, the device or goods; or
                 (C) require a medical practitioner to treat or prevent an injury, disability, incapacity, or impairment (the latter in relation to a bodily function, organ or structure), as a consequence of taking, or using, the device or goods; or
               (ii) the device or goods should not be taken, or used, in certain circumstances, which are described by reference to one or more of the following:
                 (A) a serious form, within the meaning of subsection 28(1), of a disease, condition, ailment or defect;
                 (B) an implantable device;
                 (C) a specific class of persons;
                 (D) pregnancy.
Note: A statement referred to in subparagraph (b)(ii) may be in the form of "DO NOT USE IF" followed by a reference to one of the matters mentioned in sub-subparagraphs (b)(ii)(A) to (D).