Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16GD

Notification of effective request and period within which certain applications must be decided

  (1)   This regulation applies to an application (other than an application to which regulation   16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection   9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.

  (2)   For the purposes of paragraph   63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.

  (3)   For the purposes of paragraph   63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation   (2) that the application is effective.


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