Document ID: chunk:federal_register_of_legislation:C2024C00632:section:23b:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 23B (pt 1/2)
Character Range: 199584–202382

23B  Requirements relating to applications for registration of therapeutic goods and listing of medicines under section 26AE
 (1) If an application is made under section 23 for:
 (a) registration of therapeutic goods (including an application for provisional registration of a medicine); or
 (b) the listing of a medicine under section 26AE;
the Secretary must carry out an assessment of whether the requirements set out in subsection (2) have been met in relation to the application.
 (2) The requirements are as follows:
 (a) the application must be made:
 (i) in accordance with the form approved, in writing, by the Secretary for that class of therapeutic goods; or
 (ii) in such other manner as is approved, in writing, by the Secretary for that class of therapeutic goods;
 (b) the prescribed application fee for that class of therapeutic goods must be paid;
 (c) the application must be delivered to an office of the Department specified by the Secretary;
 (d) the application must be accompanied by information that is:
 (i) of a kind determined under subsection (9) for that class of therapeutic goods; and
 (ii) in a form determined under subsection (10) for that class of therapeutic goods;
 (e) if the application is for the registration of restricted medicine—the application must be accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;
 (f) if the Secretary so requires—the applicant must:
 (i) deliver to the Department a reasonable number of samples of the goods; and
 (ii) do so in a manner approved, in writing, by the Secretary;
 (g) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—the application must be accompanied by a statement from the applicant certifying that:
 (i) if those prohibitions cover imports—any imports into Australia of the goods 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 goods 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 goods 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—the application must be accompanied by a statement from the applicant certifying that:
 (i) if those prohibitions cover imports—any imports into Australia of the goods 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 goods by, or on behalf of the applicant,