Document ID: chunk:federal_register_of_legislation:C2024C00632:section:29:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 29 (pt 2/3)
Character Range: 301038–303880

period.
 (5) The application must:
 (a) be in a form approved, in writing, by the Secretary; and
 (b) contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and
 (c) be made:
 (i) if 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—at least 6 months before the provisional registration of the medicine is due to end; or
 (ii) if 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—at least 1 month before the provisional registration of the medicine is due to end; and
 (d) be accompanied by the prescribed application fee.
 (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.
 (7) As soon as practicable after making a decision under subsection (6) or (6A), the Secretary must:
 (a) give the applicant written notice of the decision; and
 (b) if the Secretary decides to extend the provisional registration period—specify in the notice the period of the extension (which must not exceed 2 years and may be less than the period sought by the applicant); and
 (c) if the Secretary refuses to extend the provisional registration period—set out the reasons for the refusal in the notice.
Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3).
 (8) No more than