32DAApplication for inclusion in the Register

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.