Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 60

             (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)  under the definition of therapeutic devices in subsection 3(1) or under subsection 7(1) or 41BD(3); or

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

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

                     (b)  refusing to grant a consent under section 14 or 14A; or

                     (c)  under Part 3-2 (registration and listing of therapeutic goods); or

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

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

"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:

                     (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)  A person whose interests are affected by an initial decision may, by notice in writing given to the Minister:

                     (a)  in the case of a decision particulars of which are required to be notified in the Gazette --within 90 days after those particulars are so notified; or

                     (b)  in any other case--within 90 days after the decision first comes 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.

             (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.

             (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.

             (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.