Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26ab:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26AB (pt 1/3)
Character Range: 246338–249133

26AB  Application for listing of certain medicines following efficacy evaluation
 (1) If:
 (a) an application is made under section 23 for the listing of medicine in relation to a person; and
 (b) the application passes preliminary assessment; and
 (c) the requirements of subsections (2), (3), (4) and (6) have been complied with; and
 (d) the medicine is not a medicine which may be listed under section 26A; and
 (e) the medicine is not export only medicine; and
 (f) the medicine is not one that has previously had its registration or listing cancelled;
the Secretary must evaluate the medicine for listing under section 26AE.
 (2) The applicant must certify that:
 (a) the medicine is eligible for listing; and
 (b) the medicine is safe for the purposes for which it is to be used; and
 (c) the presentation of the medicine is not unacceptable; and
 (d) the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and
 (e) if a determination under paragraph 26BB(1)(b) specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and
 (f) the medicine conforms to every standard (if any) applicable to the medicine; and
 (g) both of the following are complied with in relation to the medicine:
 (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
 (h) if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step; and
 (i) the medicine complies with all prescribed quality or safety criteria that are applicable to the medicine; and
 (j) 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
 (k) 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
 (l) 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
 (m) the applicant has available sufficient information to substantiate each claim and each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and
 (n) the medicine does not contain substances that are