26AFWhen the Secretary must not use restricted information in evaluating medicine for listing under section 26AE

#### 26AF When the Secretary must not use restricted information in evaluating medicine for listing under section 26AE (1) If an application is made under section 23 for the listing of a medicine under section 26AE, then, in evaluating the medicine under section 26AE, the Secretary must not use information about other medicine that is restricted information. (2) Information is restricted information if: (a) the information was given to the Secretary in relation to an application made under section 23 for the listing of a medicine (the existing medicine) under section 26AE; and (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 (e) the existing medicine was listed under section 26AE on or after the commencement of this subsection; and (ea) the Secretary relied on the information in deciding to list the existing medicine; and (eb) at all times during the period: (i) beginning on the day the application for the listing of the existing medicine was made; and (ii) ending at the end of the day before the day that the existing medicine was included in the Register; the information (except information set out in a registry prescribed for the purposes of subparagraph (b)(ii)) was not available to the public; and (f) 5 years have not passed since the day that listing commenced; and (g) the person in relation to whom the existing medicine is listed has not given the Secretary permission in writing for the Secretary to use the information. (3) A registry prescribed for the purposes of subparagraph (2)(b)(ii): (a) may be a registry established within or outside Australia; and (b) must be a registry that is accessible by the public.