Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 26AD

Lapsing of applications

  (1)   An application for the listing of a medicine under section   26AE lapses if:

  (a)   any part of the evaluation fee referred to in section   26AC remains unpaid at the end of 28 days after the day on which the amount became due and payable; or

  (b)   the application contains information that is inaccurate or misleading in a material particular; or

  (c)   information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular.

Deemed refusal of applications

  (2)   If:

  (a)   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

  (b)   at the end of that period, the evaluation has not been completed;

the applicant may give the Secretary written notice that the applicant wishes to treat the application as having been refused.

  (3)   A notice under subsection   (2) may be given at any time before the evaluation is completed.

  (4)   If a notice has been given, this Act (except subsection   60(5)) has effect as if:

  (a)   the Secretary had decided not to list the medicine which is the subject of the application; and

  (b)   the Minister had made a decision under subsection   60(3) confirming the decision of the Secretary; and

  (c)   the Minister's decision had been made on the day on which notice was given to the Secretary under subsection   (2).