23BRequirements relating to applications for registration of therapeutic goods and listing of medicines under section 26AE

#### 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, will not contravene those conditions; 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 conditions. Passing preliminary assessment (3) An application passes preliminary assessment if the Secretary: (a) has carried out an assessment, under subsection (1), in relation to the application; and (b) is satisfied that the requirements set out in subsection (2) have been met in relation to the application. (4) If the application has passed preliminary assessment, the Secretary must give a written notice to the applicant stating that the application has passed preliminary assessment. (5) Subsection (4) does not apply if the period within which the Secretary must, under section 25, evaluate the goods to which the application relates is prescribed by reference to the prescribed period within which the Secretary is required to consider an application under subsection 9D(3) to vary an entry in the Register. (6) If the application has not passed preliminary assessment, the Secretary must, by written notice given to the applicant, refuse the application. Approval of forms etc. (7) For the purposes of paragraph (2)(a), the Secretary may approve different forms and different manners for making applications for different classes of therapeutic goods that are specified under section 23A. (8) An approval of a form may require or permit an application or information 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. Determination of kinds and forms of information (9) The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to a class of therapeutic goods that is specified under section 23A. (10) The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to a class of therapeutic goods that is specified under section 23A.