Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41LE

Reduction of conformity assessment fee where decision not made within prescribed period

  (1)   Nothing in section   41LA, 41LB or 41LC requires the applicant to pay more than 3 / 4 of the conformity assessment fee before the making of the decision if:

  (a)   the application is for the issuing of a conformity assessment certificate under Part   4 - 4; and

  (b)   consideration of the application will involve an examination of the design of medical devices; and

  (c)   a period is prescribed under paragraph   63(2)(dc) for making a decision on the application.

  (2)   If the decision is not made within that period, the conformity assessment fee is 3 / 4 of the fee that, apart from this subsection, would have been the conformity assessment fee.

  (3)   If:

  (a)   the decision is made within that period; and

  (b)   part of the conformity assessment fee under section   41LA is, because of subsection   (1) of this section, unpaid when the decision is made;

that part becomes due and payable on the making of the decision.

  (4)   For the purposes of this section, a decision is taken to be made on the application when the applicant is notified under subsection   41EE(1) of the Secretary's decision on the application.

 


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