Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16GC

Notification of preliminary assessment of applications and periods within which certain evaluations must be made

  (1)   This regulation applies to an application under section   32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section   32DE of the Act.

  (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 has passed preliminary assessment within 30 working days after the Secretary receives the application.

  (3)   For the purposes of paragraph   63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation   (2).


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