Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26 (pt 2/4)
Character Range: 232907–235635

if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those conditions; or
 (m) the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; or
 (n) one or more of the manufacturers of the goods are not nominated as manufacturers of the goods in the application.
 (1AA) If:
 (a) a medicine (the original medicine) is included in the Register in relation to a person; and
 (b) the person makes an application under section 23 for the listing of a medicine (the new medicine) under this section; and
 (ba) the application complies with section 23C; and
 (c) the Secretary is satisfied that paragraphs (1)(a) to (ba) are satisfied in relation to the application; and
 (d) the Secretary is satisfied that the new medicine has the same characteristics as the original medicine apart from the characteristics specified in an instrument under subsection (1AB);
the Secretary may list the new medicine in relation to the person.
 (1AB) The Minister may, by legislative instrument, specify characteristics for the purposes of paragraph (1AA)(d).
 (1A) To avoid doubt, if:
 (a) an application is made for the listing of therapeutic goods 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 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 goods under subsection (1) without inquiring into the correctness of the certificate or the notice.
 (2) In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:
 (a) whether the applicant has provided:
 (i) if a step in the manufacture of the goods has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the goods; or
 (ia) if a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the goods; or
 (ii) in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and
 (b) whether the applicant has agreed to provide, where the Secretary considers inspection