Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26a:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26A (pt 2/4)
Character Range: 240590–243479

prescribed quality or safety criteria that are applicable to the medicine; and
 (fa) the medicine's specifications comply with any requirements that are prescribed by the regulations for the purposes of this paragraph and that are applicable to the medicine; and
 (fb) the medicine's label:
 (i) complies with any requirements that are prescribed by the regulations for the purposes of this subparagraph and that are applicable to the medicine; and
 (ii) does not make a claim that is inconsistent with any claim made by the applicant in relation to the medicine in, or in connection with, the application; and
 (fba) if the medicine's label contains one or more indications—each indication:
 (i) is covered by a determination under paragraph 26BF(1)(a); and
 (ii) is proposed to be accepted in relation to the inclusion of the medicine in the Register; and
 (fc) the applicant holds information or evidence showing the medicine's specifications will be maintained under the conditions set out on the medicine's label until the medicine's expiry date; and
 (fd) each indication proposed to be accepted in relation to the inclusion of the medicine in the Register is covered by a determination under paragraph 26BF(1)(a); and
 (fe) if a determination under paragraph 26BF(1)(b) specifies requirements in relation to an indication proposed to be accepted in relation to the inclusion of the medicine in the Register—none of the requirements have been contravened; and
 (g) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (h) all the manufacturers of the medicine are nominated as manufacturers in the application; and
 (i) the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and
 (j) both:
 (i) the applicant holds information or evidence to support any claim (other than a claim that is an indication) proposed to be accepted in relation to the inclusion of the medicine in the Register; and
 (ii) the information or evidence complies with any requirements specified in a determination under subsection (2B); and
 (ja) both:
 (i) the applicant holds information or evidence to support each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and
 (ii) the information or evidence complies with any requirements specified in a determination under subsection (2B); and
 (k) the information included in or with the application is correct.
 (2A) The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection.
 (2B) The Minister may, by legislative instrument, specify requirements for the purposes of subparagraph (2)(j)(ii) or (2)(ja)(ii).
 (3) Subject to subsection (7), if a step in the manufacture of the medicine