Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) In this regulation:
"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975 .
"initial decision" means a decision of the Secretary under any of the following provisions:
(a) subregulation 9 (1);
(c) subregulation 10A (7);
(ca) subregulation 10C (3), (4), (5) or (6);
(d) subregulation 10F (7);
(e) subregulation 16J (3);
(f) subregulation 22 (8);
(g) regulation 45;
(h) regulation 45AA.
"reviewable decision" means a decision of the Minister under subregulation (3).
(1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to:
(a) an officer of the Department; or
(b) the National Manager, Therapeutic Goods Administration.
(2) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice.
(3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and 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.
(4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.
(5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 28 (4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision.
(6) If written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may:
(a) seek a reconsideration of the decision under this regulation; and
(b) subject to the Administrative Appeals Tribunal Act 1975 , if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.
(7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.
(8) An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.