Document ID: chunk:federal_register_of_legislation:C2024C00632:section:60:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 60 (pt 1/4)
Character Range: 1113977–1116735

60  Review of decisions
 (1) In this section and section 60A:
decision has the same meaning as in the Administrative Review Tribunal Act 2024.
initial decision means a decision of the Secretary or of a delegate of the Secretary:
 (a) refusing to make, or refusing to vary or repeal, a declaration under section 7 upon an application made under subsection 7(2); or
 (aa) under subsection 7C(3); or
 (ab) under section 9C, 9D or 9F; or
 (b) refusing to grant, or imposing conditions on a grant of, a consent under section 14 or 14A; or
 (c) under Part 3‑2 (registration and listing of therapeutic goods), other than a decision under paragraph 26BE(4)(a), or a decision under subsection 26BJ(8), to make a recommendation; or
 (ca) under Part 3‑2A (Biologicals); or
 (d) under Part 3‑3 (manufacturing of therapeutic goods); or
 (e) under Part 4‑4 (conformity assessment certificates); or
 (f) under Part 4‑5 (including medical devices in the Register), other than:
 (i) a decision under section 41FH (selecting applications for auditing); or
 (ii) a decision about which aspects of the matters referred to in paragraphs 41FI(1)(a) and (b) to consider in auditing an application under Subdivision C of Division 1 of Part 4‑5; or
 (g) under Part 4‑6 (suspension and cancellation from the Register); or
 (h) under Part 4‑7 (exempting medical devices from inclusion in the Register); or
 (j) under Part 4‑9 (public notification and recovery of medical devices); or
 (k) refusing to grant, or imposing conditions on a grant of, a consent for the purposes of section 41MA or 41MAA (non‑compliance with essential principles); or
 (ka) refusing to give a consent under subsection 41RC(1), or giving such a consent subject to conditions imposed under subsection 41RC(2); or
 (l) under section 42DF, 42DH or 42DI or subsection 42DV(1) or (2); or
 (m) under subsection 42DZK(1) or (2); or
 (n) to give directions under subsection 42YT(2).
reviewable decision means a decision of the Minister under subsection (3).
 (1AA) A decision under a provision of this Act to give a notice to a person requiring the person to give information, or give or produce documents, to the Secretary is not an initial decision for the purposes of this section.
 (1A) For the avoidance of doubt, the following are not initial decisions for the purposes of this section or section 60A:
 (aaa) the giving of advice under section 22G;
 (aa) a preliminary assessment under section 23B, 26BD, 32DDA or 41FDB;
 (a) a proposal to suspend a conformity assessment certificate under section 41EM;
 (b) a proposal to revoke a conformity assessment certificate under section 41ET;
 (c) a proposal to suspend a kind of medical device from the Register under section 41GA;
 (d) a proposal to cancel the entry