Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 24D

Reduction of evaluation fee where evaluation not completed within prescribed period

             (1)  This section applies to an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da).

             (2)  Nothing in section 24, 24A or 24B requires the applicant to pay more than three‑quarters of the evaluation fee before the completion of the evaluation of the goods.

             (3)  If the evaluation is not completed within the period referred to in subsection (1), this Act has effect as if the evaluation fee were reduced to three‑quarters of the fee that, under the regulations, would have been the evaluation fee.

             (4)  If:

                     (a)  the evaluation is completed within the period referred to in subsection (1); and

                     (b)  part of the evaluation fee under section 24 is unpaid when the evaluation is completed;

that part becomes due and payable on the completion of the evaluation.

             (5)  For the purposes of subsections (2), (3) and (4), the evaluation is to be taken to be completed when the applicant is notified according to subsection 25(3) of the Secretary's decision on the application.

             (6)  Despite subsection (5), if:

                     (a)  the Secretary has given the applicant all evaluation reports relating to the application; and

                     (b)  the Secretary has given those reports, or proposes to give those reports, to a committee established under the regulations to advise the Secretary on applications to register therapeutic goods to which subsection (1) applies; and

                     (c)  the applicant withdraws the application after being given the reports, and before the end of the period mentioned in subsection (1);

the evaluation is taken for the purposes of subsections (2), (3) and (4) to be completed immediately before the time of withdrawal.



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