Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32dda:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32DDA (pt 2/2)
Character Range: 475224–477280

contravene those conditions.

Passing preliminary assessment
 (3) An application passes preliminary assessment if the Secretary:
 (a) has carried out an assessment, under subsection (1), in relation to the application; and
 (b) is satisfied that the requirements set out in subsection (2) have been met in relation to the application.
 (4) If the application has passed preliminary assessment, the Secretary must give a written notice to the applicant stating that the application has passed preliminary assessment.
 (5) Subsection (4) does not apply if the period within which the Secretary must, under section 32DE, evaluate the biological to which the application relates is prescribed by reference to the prescribed period within which the Secretary is required to consider an application under subsection 9D(3) to vary an entry in the Register.
 (6) If the application has not passed preliminary assessment, the Secretary must, by written notice given to the applicant, refuse the application.

Approval of different forms etc.
 (7) For the purposes of paragraph (2)(a), the Secretary may approve different forms and manners for making applications for different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA.
 (8) 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.

Determination of kinds and forms of information
 (9) The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to a class of biological that is prescribed by the regulations for the purposes of section 32AA.
 (10) The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to a class of biological that is prescribed by the regulations for the purposes of section 32AA.