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THERAPEUTIC GOODS ACT 1989 - SECT 32DM Reduction of evaluation fee where evaluation not completed within prescribed period

THERAPEUTIC GOODS ACT 1989 - SECT 32DM

Reduction of evaluation fee where evaluation not completed within prescribed period

  (1)   Nothing in section   32DI, 32DJ or 32DK requires the applicant to pay more than 3 / 4 of the evaluation fee before the completion of the evaluation if a period is prescribed under paragraph   63(2)(daa) for completing the evaluation.

  (2)   The Secretary must notify the applicant in writing of the day the evaluation is completed.

  (3)   If the evaluation is not completed within that period, the evaluation fee is 3 / 4 of the fee that, apart from this subsection, would have been the evaluation fee.

  (4)   If:

  (a)   the evaluation is completed within that period; and

  (b)   part of the evaluation fee under section   32DI is unpaid when the evaluation is completed;

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

  (5)   For the purposes of this section, if a copy of the evaluation report, or a summary of that report, is given to either or both of the following:

  (a)   the applicant;

  (b)   a committee established under the regulations to advise the Secretary on applications to include biologicals in the Register where a period for evaluating the biologicals is prescribed under paragraph   63(2)(daa);

then the evaluation is taken to be completed immediately before the first copy or summary is so given.

Note:   This subsection has the effect that if the applicant withdraws the application after being given a copy of the evaluation report, or a summary of that report, before the end of that period, the full evaluation fee is due and payable by the applicant.

  (6)   A notification under subsection   (2) is not a legislative instrument.

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