Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 22C

Applications for provisional determination

             (1)  A person may make an application to the Secretary for a provisional determination relating to a medicine of a kind prescribed by the regulations for the purposes of this subsection.

Note:          If the Secretary makes the determination, the person applies under section 23 for registration of the medicine and that application passes preliminary assessment, then a different kind of evaluation of the medicine will occur under section 25.

             (2)  An application under subsection (1) must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary; and

                     (b)  be accompanied by the prescribed application fee; and

                     (c)  contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and

                     (d)  satisfy any other requirement prescribed by the regulations for the purposes of this paragraph.

             (3)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.



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