Document ID: chunk:federal_register_of_legislation:C2021A00008:clause:5_1
Version: federal_register_of_legislation:C2021A00008
Segment Type: clause
Provision Reference: sch 5 cl 1
Character Range: 40681–42245

1  Paragraphs 26AF(2)(b), (c) and (d)
Repeal the paragraphs, substitute:
 (b) the information is derived from a clinical trial in relation to an indication of the existing medicine, where:
 (i) the trial number of that trial is specified in the application for the listing of the existing medicine; and
 (ii) the Secretary is satisfied that the trial number of that trial is set out in a registry prescribed by the regulations for the purposes of this subparagraph; and
 (c) that indication is either:
 (i) a use of the existing 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) a use of the existing 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
 (d) at the time (the relevant time) the application for the listing of the existing medicine was made:
 (i) that indication was not covered by a determination under paragraph 26BF(1)(a); and
 (ii) no other medicine with that indication, and with the same active ingredients as the existing medicine, was included in the Register under section 26AE; and
 (da) no other medicine with that indication, and with the same active ingredients as the existing medicine, had been included in the Register under section 26AE at any time before the relevant time; and