Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16gi
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16GI
Character Range: 254980–256351

16GI  Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made
 (1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:
 (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and
 (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.

Notification of preliminary assessment of applications and period within which decisions on recommendations must be made
Item                                                                                                                      Column 1             Column 2                                                             Column 3

                                                                                                                          Kind of application  Notification of preliminary assessment                               Decision on recommendation