Document ID: chunk:federal_register_of_legislation:C2024C00632:section:60a:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 60A (pt 2/3)
Character Range: 1126338–1129031

the authorised delegate must make a decision under section 25, taking into account the initial new information or later new information (or both), as the case may be, as if a fresh application for registration had been made.
 (6AA) If:
 (a) the matter relates to a decision under section 32DF or 32DG; and
 (b) the Minister or the Tribunal remits the matter; and
 (c) the appellant has paid, as a further evaluation fee, the evaluation fee that the appellant would have to pay under section 32DI on making a new application for inclusion of the biological in the Register;
the authorised delegate must make a decision whether or not to include the biological in the Register, taking into account the initial new information or later new information (or both), as the case may be, as if a fresh application for inclusion of the biological in the Register had been made.
 (6A) If:
 (a) the matter relates to a decision under section 41EC; and
 (b) the Minister or the Tribunal remits the matter; and
 (c) the appellant has paid, as a further conformity assessment fee, the conformity assessment fee that the appellant would have to pay under section 41LA on making a new application for a conformity assessment certificate;
the authorised delegate must make a decision under section 41EC, taking into account the initial new information or later new information (or both), as the case may be, as if a fresh application for a conformity assessment certificate had been made.
 (7) To remove any doubt, the authorised delegate's fresh decision is to be treated, for the purposes of subsequent applications of section 60 and this section, as a decision under Part 3‑2, 3‑2A or 4‑4.
 (8) In this section:
authorised delegate means a delegate of the Secretary:
 (a) exercising a power to decide whether to register therapeutic goods; or
 (aa) exercising a power to decide whether to include a biological in the Register; or
 (b) exercising a power to decide whether to issue a conformity assessment certificate.
initial new information means information that:
 (a) was in existence at the time the decision referred to in subsection (1) was made; and
 (b) was not made available to the Secretary or authorised delegate for the purpose of making that decision; and
 (c) is relevant to that decision;
and includes any opinions that are wholly or substantially based on such information (whether the opinions were formed before or after that decision was made).
later new information means information that:
 (a) was in existence at the time the decision on reconsideration was made; and
 (b) was not made available to the Minister or delegate of the Minister for the purpose of making that decision; and