Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26 (pt 3/4)
Character Range: 235375–238017

(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 of the manufacturing procedures used in the manufacture of the goods to be necessary:
 (i) funds for the carrying out of that inspection by the Department; and
 (ii) evidence that the manufacturer has agreed to such an inspection.
 (2A) If therapeutic goods are exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.
 (2B) If a person is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3‑3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.
 (2C) If:
 (a) therapeutic goods were made outside Australia; and
 (b) had the goods been made in Australia, they would have been exempt from the operation of Part 3‑3;
subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.
 (2D) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:
 (a) the general standards of manufacturing practice of a particular manufacturer; or
 (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.
 (2E) For the purposes of subsection (2D), a Convention country is a country that is a party to the Mutual Recognition Convention.
 (2F) Information referred to in subsection (2D) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3‑3 of this Act.
 (3) Where an application is made, the Secretary must notify the applicant in writing of his or her decision on the application within 28 days of the making of the decision and, in the case of a decision not to list the goods, of the reasons for the decision.
 (4) As soon as practicable after an applicant has been informed that therapeutic goods in respect of which an application was made are acceptable for listing, the Secretary must give to the applicant a certificate of listing of the goods, and the listing of the goods commences on