Document ID: chunk:federal_register_of_legislation:C2020A00075:clause:9_26af
Version: federal_register_of_legislation:C2020A00075
Segment Type: clause
Provision Reference: sch 9 cl 26AF
Character Range: 34214–35660

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, being an indication that is not covered by a determination under paragraph 26BF(1)(a); and
 (c) the information is not available to the public; and
 (d) at the time the application to list the existing medicine was made:
 (i) no other medicine with that indication was included in the Register; and
 (ii) no other medicine with that indication had been included in the Register at any time before that time; and
 (e) the existing medicine was listed under section 26AE on or after the commencement of this subsection; 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.