Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16d
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16D
Character Range: 231717–233227

16D  Applications for variations—notification of effectiveness and period for deciding applications—general

Application of this regulation
 (1) This regulation applies if the Secretary receives an application:
 (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and
 (b) to which regulation 16F does not apply.

Giving notification of effectiveness of application
 (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.

Period for completing evaluation in relation to application
 (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:
 (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or
 (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or
 (c) otherwise—255 working days;
beginning on the day the Secretary sends the notification that states that the application is effective.