26ADLapsing and deemed refusal of applications for listing of medicine under section 26AE

26AD Lapsing and deemed refusal of applications for listing of medicine under section 26AE

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).