THERAPEUTIC GOODS ACT 1989 - SECT 22C Applications for provisional determination

THERAPEUTIC GOODS ACT 1989 - SECT 22C

  (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.