Document ID: chunk:federal_register_of_legislation:C2024C00632:section:25:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 25 (pt 2/3)
Character Range: 214289–217050

subsection 9K(1) or (3)—whether, if the Secretary were to register the goods, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the goods would contravene those prohibitions; and
 (ia) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—whether, if the Secretary were to register the goods, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the goods would contravene those conditions; and
 (j) whether the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (ja) whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and
 (k) such other matters (if any) as the Secretary considers relevant.
Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.
 (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 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.
 (2AA) If:
 (a) the applicant is applying for the registration of a medicine; and
 (b) the Secretary has given the applicant or any other person advice under section 22G in relation to the medicine;
the Secretary must have regard to the advice in evaluating the medicine under this section.
 (2AB) Subsection (2AA) does not limit the matters the Secretary may take into account in evaluating the medicine under this section.
 (2A) An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period.
 (2B) If therapeutic goods are exempt from the operation