32DCAApplication for inclusion in the Register

32DCA Application for inclusion in the Register

Application (1) A person may make an application to the Secretary to include an export only biological in the Register. (2) The 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 made by the applicant certifying the matters mentioned in subsection (4); and (c) be accompanied by the fee prescribed by regulations made for the purposes of this paragraph. (3) 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. Certification of matters (4) The matters the applicant must certify are: (a) that the biological is an export only biological; and (b) that the biological is safe for the purposes for which it is to be used; and (c) that the presentation of the biological is not unacceptable; and (d) that the biological conforms to every standard (if any) applicable to it; and (e) that the requirements (if any) relating to advertising applicable under Part 5‑1 or under the regulations are complied with in relation to the biological; and (f) that the biological complies with all prescribed quality or safety criteria that are applicable to it; and (g) that all the manufacturers of the biological are nominated as manufacturers in the application; and (h) if a step in the manufacture of the biological has been carried out in Australia—that the biological is exempt from the operation of Part 3‑3 or that the step has been carried out by a person who: (i) is the holder of a licence to carry out that step; or (ii) is exempt from the operation of that Part in relation to that step; and (i) that the biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and (j) 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—that 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—that any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and (k) 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—that 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—that any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and (l) any other matter prescribed by regulations made for the purposes of this paragraph. Manufacturing steps outside Australia (5) Subject to subsection (7), if one or more steps in the manufacture of the biological have been carried out outside Australia, the Secretary must certify, or refuse to certify, that the manufacturing and quality control procedures used in each such step are acceptable.