Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16C

Applications for registration--notification of effectiveness and period for completing evaluations--general

Application of this regulation

  (1)   This regulation applies if the Secretary receives an application:

  (a)   made under section   23 of the Act for the registration of a medicine that is a product of a kind specified in Part   1 of Schedule   10 to these Regulations; and

  (b)   to which regulation   16G does not apply.

Giving notification whether application has passed preliminary assessment

  (2)   For the purposes of paragraph   63(2)(de) of the Act, 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 has passed preliminary assessment.

Period for completing evaluation in relation to application

  (3)   For the purposes of paragraph   63(2)(da) of the Act, if section   25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:

  (a)   if the conditions mentioned in subregulations   16DA(1) and (2) are satisfied--120 working days; or

  (b)   if the conditions mentioned in subregulation   16DA(1) are satisfied, but a condition mentioned in subregulation   16DA(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 has passed preliminary assessment.


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