Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 32GB

Immediate cancellation of biological from the Register after failure to comply with information gathering notice

  (1)   The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

  (a)   the Secretary gives to the person a notice under section   32JA requiring the person to give to the Secretary information, or to produce to the Secretary documents, relating to the biological; and

  (b)   the notice under section   32JA is given for the purposes of ascertaining whether any of the certifications by the person under subsection   32DA(3) or 32DCA(4) in relation to the biological are incorrect; and

  (c)   the person fails to comply with the notice under section   32JA within a further 14 days after the end of the period specified in that notice.

  (2)   The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

  (a)   the Secretary gives to the person a notice under section   32JA requiring the person to give to the Secretary information, or to produce to the Secretary documents, relating to whether the biological is being:

  (i)   supplied in Australia; or

  (ii)   imported into Australia; or

  (iii)   exported from Australia; and

  (b)   either:

  (i)   the information or documents given are to the effect that the biological is not being supplied in Australia, imported into Australia or exported from Australia; or

  (ii)   the person fails to comply with the notice under section   32JA within a further 14 days after the end of the period specified in that notice.

  (3)   A notice under subsection   (1) or (2) is not a legislative instrument.



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