Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:4_8
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 4 cl 8
Character Range: 505697–507079

8         medicines to be listed under section 26AE of the Act, if:
          (a) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and
          (b) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and
          (c) the ingredients in the medicine are not of a kind required to be sterile; and
          (ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and
          (d) the indications proposed by the sponsor of the medicine are either:
          (i) uses of the medicine in preventing, curing or alleviating a disease, ailment, defect or injury in persons, other than a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; or
          (ii) uses of the medicine in connection with alleviating a disease, ailment, defect or injury in persons, being a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; and
          (e) the indications proposed by the sponsor of the medicine do not refer to an indication that is or contains a prohibited representation (within the meaning of Part 5‑1 of the Act