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THERAPEUTIC GOODS ACT 1989 - SECT 60

Review of decisions

             (1)  In this section and section 60A:

"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975 .

"initial decision" means a decision of the Secretary or of a delegate of the Secretary:

                     (a)  refusing to make, or refusing to vary or repeal, a declaration under section 7 upon an application made under subsection 7(2); or

                    (aa)  under subsection 7C(3); or

                   (ab)  under section 9C, 9D or 9F; or

                     (b)  refusing to grant, or imposing conditions on a grant of, a consent under section 14 or 14A; or

                     (c)  under Part 3-2 (registration and listing of therapeutic goods), other than a decision under paragraph 26BE(4)(a), or a decision under subsection 26BJ(8), to make a recommendation; or

                    (ca)  under Part 3-2A (Biologicals); or

                     (d)  under Part 3-3 (manufacturing of therapeutic goods); or

                   (da)  under subsection 41BD(3); or

                     (e)  under Part 4-4 (conformity assessment certificates); or

                      (f)  under Part 4-5 (including medical devices in the Register), other than:

                              (i)  a decision under section 41FH (selecting applications for auditing); or

                             (ii)  a decision about which aspects of the matters referred to in paragraphs 41FI(1)(a) and (b) to consider in auditing an application under Subdivision C of Division 1 of Part 4-5; or

                     (g)  under Part 4-6 (suspension and cancellation from the Register); or

                     (h)  under Part 4-7 (exempting medical devices from inclusion in the Register); or

                      (i)  under Part 4-8 (obtaining information); or

                      (j)  under Part 4-9 (public notification and recovery of medical devices); or

                     (k)  refusing to grant, or imposing conditions on a grant of, a consent for the purposes of section 41MA or 41MAA (non-compliance with essential principles); or

                      (l)  under section 42DF, 42DH or 42DI or subsection 42DV(1) or (2).

"reviewable decision" means a decision of the Minister under subsection (3).

          (1A)  For the avoidance of doubt, the following are not initial decisions for the purposes of this section or section 60A:

                  (aaa)  the giving of advice under section 22G;

                    (aa)  a preliminary assessment under section 23B, 26BD, 32DDA or 41FDB;

                     (a)  a proposal to suspend a conformity 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 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.

             (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 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.

          (5A)  If:

                     (a)  the initial decision is one the particulars of which are required to be published in the Gazette or on the Department's website; and

                     (b)  the Minister revokes the initial decision;

the Secretary must, as soon as practicable after the revocation, cause to be published in the Gazette , or on the Department's website, a notice setting out particulars of the revocation.

          (5B)  If:

                     (a)  the initial decision is one the particulars of which are required to be published in the Gazette or on the Department's website; and

                     (b)  the Minister revokes the initial decision and makes a decision (the substituted decision ) in substitution for the initial decision;

the Secretary must, as soon as practicable after the substituted decision is made, cause to be published in the Gazette , or on the Department's website, a notice setting out particulars of the substituted decision.

             (6)  Where 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 section; 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 subsection (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.



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