Document ID: chunk:federal_register_of_legislation:C2024C00632:section:60:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 60 (pt 2/4)
Character Range: 1116485–1119207

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 of a kind of medical device on the Register under section 41GN.
 (2) Subject to this section, a person whose interests are affected by an initial decision may, by notice in writing given to the Minister:
 (a) if this Act requires the person to be given notice in writing of the decision, or of particulars of the decision—within 90 days after the notice is given to the person; or
 (b) otherwise—within 90 days after the earlier of:
 (i) notice of the decision, or of particulars of the decision, being published in the Gazette or on the Department's website; and
 (ii) the decision first coming to the person's notice;
request the Minister to reconsider the decision.
 (2A) A request under subsection (2) may be accompanied by information in support of the request.
 (2AA) If the Secretary or a delegate of the Secretary makes a decision under subsection 9D(1A) or (1B) to vary an entry in the Register in relation to a medicine, a person is not entitled to request the Minister to reconsider the decision unless the person is the person in relation to whom the medicine is registered.
 (2AB) If the Secretary or a delegate of the Secretary:
 (a) makes a decision under section 22D in relation to an application under section 22C; or
 (b) makes a decision under section 22E in relation to an application under subsection 22E(3); or
 (d) makes a decision under subsection 25(3) in relation to an application for provisional registration of a medicine;
a person is not entitled to request the Minister to reconsider the decision unless the person made the application.
 (2AC) If the Secretary or a delegate of the Secretary makes a decision under section 22F to revoke a provisional determination under section 22D, a person is not entitled to request the Minister to reconsider the decision unless the person made the application for that provisional determination.
 (2B) If the Secretary or a delegate of the Secretary decides, under paragraph 26BE(4)(b), to refuse to make a recommendation, a person is not entitled to request the Minister to reconsider the decision unless the person made an application under subsection 26BD(1) for the recommendation.
 (2C) If the Secretary or a delegate of the Secretary decides, under subsection 26BJ(8), to refuse to make a recommendation, a person is not entitled to request the Minister to reconsider the decision unless the person made an application under subsection 26BJ(1) for the recommendation.
 (2D) If the Secretary or a