THERAPEUTIC GOODS ACT 1989 - SECT 32DA Application for inclusion in the Register
THERAPEUTIC GOODS ACT 1989 - SECT 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.
(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.