Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16gh
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16GH
Character Range: 248635–249960

16GH  Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed
 (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—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.

Notification of preliminary assessment of application and period within which evaluations must be completed
Item                                                                                                         Column 1                         Column 2                                                             Column 3

                                                                                                             Kind of application              Notification of preliminary assessment                               Completion of evaluation