Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26 (pt 1/4)
Character Range: 230467–233145

26  Listing of therapeutic goods
 (1) Where:
 (a) an application is made for the listing of therapeutic goods in relation to a person under section 23; and
 (aaa) the application complies with section 23C; and
 (aa) 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
 (b) the person has complied with any requirements made by the Secretary under section 31 in relation to the goods; and
 (ba) the goods are not goods which may be listed under section 26A or 26AE;
then, subject to this section, the Secretary is not to refuse to list the goods in relation to the person except where the Secretary is satisfied that:
 (c) the goods are not eligible for listing; or
 (d) the goods are not safe for the purposes for which they are to be used; or
 (e) the presentation of the goods is unacceptable; or
 (f) the goods do not conform to a standard applicable to the goods; or
 (fa) either of the following has not been complied with in relation to the goods:
 (i) an applicable provision of the Therapeutic Goods Advertising Code;
 (ii) any other requirement relating to advertising applicable under Part 5‑1 or the regulations; or
 (g) if a step in the manufacture of the goods has been carried out outside Australia—the manufacturing and quality control procedures used in the manufacture of the goods are not acceptable; or
 (h) if the goods have been manufactured in Australia—the goods have been manufactured contrary to Part 3‑3; or
 (j) if the goods have been manufactured in Australia, or imported into Australia, solely for export—a relevant authority of the country to which the goods are to be exported has not confirmed its willingness to accept the goods and:
 (i) the goods have been refused registration or listing for supply in Australia; or
 (ii) the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or
 (k) the goods do not comply with prescribed quality or safety criteria; or
 (l) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those prohibitions; or
 (la) 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