Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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.