Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26a:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26A (pt 1/4)
Character Range: 238073–240852

26A  Listing of certain medicines
 (1) If:
 (a) an application is made for the listing of medicine in relation to a person under section 23; and
 (aa) the application complies with section 23C; and
 (b) the application is accompanied by either:
 (i) the certificate required under subsection 26B(1); or
 (ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and
 (c) the requirements of subsection (2) and (where applicable) subsections (2A), (3) and (4A) have been complied with; and
 (d) the medicine is not export only medicine; and
 (e) the medicine is not one that has previously had its registration or listing cancelled;
the Secretary must list the medicine in relation to the person.
 (1A) To avoid doubt, if:
 (a) an application is made for the listing of a medicine in relation to a person in accordance with section 23; and
 (aa) the application complies with section 23C; and
 (b) the application is accompanied by either:
 (i) the certificate required under subsection 26B(1); or
 (ii) a notice that a certificate under that subsection is not required in relation to the application; and
 (c) the other requirements in subsection (1) are met;
the Secretary must list the medicine under subsection (1) without inquiring into the correctness of the certificate or the notice.
 (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
 (ca) the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and
 (cb) 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
 (d) the medicine conforms to every standard (if any) applicable to the medicine; and
 (da) 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
 (e) 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
 (f) the medicine complies with all 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