Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32da
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32DA
Character Range: 460741–463435

32DA  Application for inclusion in the Register
 (1) A person may make an application to the Secretary to include a Class 1 biological in the Register.
 (2) An application must:
 (a) be made in accordance with a form that is approved, in writing, by the Secretary; and
 (b) be accompanied by a statement certifying the matters mentioned in subsection (3); and
 (c) be delivered to an office of the Department specified in the form; and
 (d) be accompanied by the prescribed application fee.
 (3) The applicant must certify that:
 (a) the biological is a Class 1 biological; and
 (b) the biological is safe for the purposes for which it is to be used; and
 (c) the biological conforms to every standard (if any) applicable to it; and
 (d) both of the following are complied with in relation to the biological:
 (i) the applicable provisions of the Therapeutic Goods Advertising Code;
 (ii) the other requirements (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and
 (e) the biological complies with all prescribed quality or safety criteria that are applicable to it; and
 (f) the biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (g) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3):
 (i) if those prohibitions cover imports—any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and
 (ii) if those prohibitions cover exports—any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and
 (iii) if those prohibitions cover supplies—any supplies in Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and
 (h) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions:
 (i) if those prohibitions cover imports—any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and
 (ii) if those prohibitions cover exports—any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and
 (iii) if those prohibitions cover supplies—any supplies in Australia of the biological by, or on behalf of the applicant, will not contravene those conditions.
 (4) An approval of a form may require or permit an application 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.