Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT ACT 1991 No. 204 of 1991 - SECT 10

10.(1) Section 24 of the Principal Act is amended by omitting subsection (2)
and substituting the following subsections:

"(2) Subject to section 24D, 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.".

(2) The amendment made by subsection (1) does not apply to applications made
under section 23 of the Principal Act before the commencement of this Act.