Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) This section applies only if the Secretary or an authorised delegate makes a decision under section 25, 32DF, 32DG or 41EC in relation to therapeutic goods.
(2) If a person (the appellant ) whose interests are affected by the decision requests the Minister to reconsider the decision, and lodges initial new information in support of that request, the Minister must either:
(a) take that information into account when he or she reconsiders the decision; or
(b) remit the matter to an authorised delegate for a fresh decision.
(3) If the appellant applies to the Administrative Review Tribunal for review of the decision on reconsideration, and lodges initial new information or later new information (or both) in support of that application, the Tribunal may, if the Tribunal thinks fit, remit the matter to an authorised delegate for a fresh decision.
(4) If:
(a) the appellant applies to the Administrative Review Tribunal for review of the decision on reconsideration and lodges initial new information in support of that application; and
(b) the appellant does not lodge later new information in support of that application;
the Tribunal must not remit the matter under subsection (3) if all of the initial new information is information that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration.
(5) If:
(a) the appellant lodges initial new information or later new information (or both) in support of an application to the Administrative Review Tribunal for review of the decision on reconsideration; and
(b) the Tribunal does not remit the matter under subsection (3);
the Tribunal, in reviewing the decision on reconsideration:
(c) may consider initial new information (if any) that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration; and
(d) must not consider any other initial new information, except initial new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable; and
(e) must not consider any later new information, except later new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.
(6) If:
(aa) the matter relates to a decision under section 25; and
(a) the Minister or the Tribunal remits the matter; and
(b) the appellant has paid, as a further evaluation fee, the evaluation fee that the appellant would have to pay under section 24 on making a new application for registration of the therapeutic goods;
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
(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).