Document ID: chunk:federal_register_of_legislation:C2020A00075:clause:8_6
Version: federal_register_of_legislation:C2020A00075
Segment Type: clause
Provision Reference: sch 8 cl 6
Character Range: 30015–31342

6  Subsection 29(6)
Repeal the subsection, substitute:
 (6) If:
 (a) a person makes an application under subsection (4) in accordance with this section; and
 (b) the medicine is provisionally registered because of an application that, under subsection 23AA(1), was taken to be an application for provisional registration of the medicine;
the Secretary must decide to grant, or to refuse to grant, an extension of the provisional registration period. In making that decision, the Secretary must have regard to:
 (c) whether the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years starting on the day the provisional registration commenced; and
 (d) such other matters (if any) as the Secretary considers relevant.
 (6A) If:
 (a) a person makes an application under subsection (4) in accordance with this section; and
 (b) the medicine is provisionally registered because of an application that, under subsection 23AA(2), was taken to be an application for provisional registration of the medicine;
the Secretary must decide to grant, or to refuse to grant, an extension of the provisional registration period. In making that decision, the Secretary must have regard to such matters as the Secretary considers relevant.