Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 42DI

Withdrawal of approval

             (1)  The Secretary, by written notice, may withdraw the approval of the use of a restricted representation if:

                     (a)  the Secretary is satisfied that:

                              (i)  information given by the applicant in the application was false or incorrect and the Secretary, or the Minister on review of a decision of the Secretary under section 42DF or 42DH, relied on the information in deciding to approve the use of the representation; or

                             (ii)  the restricted representation has become a prohibited representation; or

                            (iii)  there has been a breach of a condition of approval; or

                     (b)  both:

                              (i)  additional information about the safety of the therapeutic goods becomes available; and

                             (ii)  the Secretary is satisfied that, if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation; or

                     (c)  the use of the restricted representation is permitted under subsection 42DK(1).

             (2)  The notice must:

                     (a)  give the Secretary's reasons for the withdrawal; and

                     (b)  inform the approval holder of the approval holder's right to have the Secretary's decision reviewed by the Minister under section 60.



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