THERAPEUTIC GOODS ACT 1989 - SECT 26AC Evaluation fees for listing of medicine under section 26AE

THERAPEUTIC GOODS ACT 1989 - SECT 26AC

  (1)   This section applies if:

  (a)   an application is made under section   23 in relation to a medicine for listing under section   26AE; and

  (b)   the application has passed preliminary assessment.

  (2)   A fee (the evaluation fee ) specified in or determined in accordance with the regulations is payable by the applicant in respect of the evaluation of a medicine for listing under section   26AE.

  (3)   The Secretary must notify each applicant of the amount of the evaluation fee.

  (4)   The evaluation fee payable by an applicant:

  (a)   is due and payable on the day on which the applicant is notified of the amount of the evaluation fee; and

  (b)   may be recovered by the Commonwealth as a debt due to the Commonwealth.

  (5)   If:

  (a)   an application is made under section   23 in relation to a medicine for listing under section   26AE; and

  (b)   the applicant has paid the whole of the evaluation fee; and

  (c)   regulations made for the purposes of paragraph   63(2)(daaaa) prescribe a period within which evaluations under section   26AE in relation to the medicine must be completed; and

  (d)   the evaluation is completed, but not within that period;

then 25% of the evaluation fee must be refunded to the applicant.

  (6)   For the purposes of paragraph   (5)(d), the evaluation is taken to be completed when the applicant is notified of the Secretary's decision under subsection   26AE(3) in relation to the medicine.