Document ID: chunk:federal_register_of_legislation:C2024C00632:section:60:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 60 (pt 3/4)
Character Range: 1118955–1121745

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 delegate of the Secretary:
 (a) makes a decision under subsection 29(6) or (6A) in relation to an application under subsection 29(4); or
 (b) makes a decision under subsection 29(9) to end, or extend, the provisional registration period for 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 provisionally registered.
 (2E) If the Secretary or a delegate of the Secretary makes a decision to give directions under subsection 42YT(2), a person is not entitled to request the Minister to reconsider the decision unless the person is the person to whom the directions were given.
 (3) Subject to paragraph 60A(2)(b), the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may:
 (a) confirm the initial decision; or
 (b) revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
 (3A) Subject to subsection 60A(2), in reconsidering the initial decision:
 (a) the Minister must take into account any information referred to in subsection (2A); and
 (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than:
 (i) information provided in response to a request from the Minister; or
 (ii) information that indicates that the quality, safety or efficacy of therapeutic goods is unacceptable.
 (3B) Paragraph (3A)(a) does not limit the information the Minister may take into account in reconsidering the initial decision.
 (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision then the substituted decision:
 (a) is taken to be a decision of the Secretary (except for the purpose of any review of the substituted decision); and
 (b) has effect, or is taken to have had effect, on and from the date determined by the Minister.
 (4) Where a person who has made a request under subsection (2) does not receive notice of the decision of the Minister on reconsideration, or (if applicable) notice that the matter has been remitted under paragraph 60A(2)(b), within 60 days of the making of the request, the Minister is taken to have confirmed under subsection (3) the initial decision.
 (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the