Commonwealth Consolidated Acts

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Applications for registration

             (1)  This section applies if:

                     (a)  an application is made for the registration of therapeutic goods under section 23; and

                     (b)  the goods are goods that are required to be registered; and

                     (c)  the application has passed preliminary assessment.

          (1A)  A fee specified in, or determined in accordance with, the regulations is payable by the applicant in respect of the evaluation of the goods for registration, and the Secretary must notify each such applicant of the amount of the evaluation fee.

             (2)  An application for registration of therapeutic goods lapses if:

                     (a)  any part of the evaluation fee payable in respect of those goods remains unpaid at the end of the period of 2 months 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, including information given for the purpose of a requirement under section 31, is inaccurate or misleading in a material particular; or

                     (d)  the applicant fails to comply with a requirement under section 31 to give information consisting of individual patient data in relation to the goods.

             (3)  In this section, individual patient data , in relation to therapeutic goods, means information, derived from clinical trials, relating to individuals before, during and after the administration of the goods to those individuals, including, but not limited to, demographic, biochemical and haematological information.

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