Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) An application under section 32DD for inclusion of a biological in the Register lapses if:
(a) any part of the evaluation fee payable in respect of the biological remains unpaid at the end of the period of 42 days after the day on which the part became due and payable; or
(b) information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 32JA, is false or misleading in a material particular; or
(c) the applicant fails to comply with a requirement under section 32JA to give information consisting of patient data in relation to the biological.
"patient data" , in relation to a biological, means information, derived from
clinical trials, relating to individuals before, during and after the
administration of the biological to those individuals, including, but not
limited to, demographic, biochemical and haematological information.