Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 32GC

  (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)   it appears to the Secretary that the quality, safety or efficacy of the biological is unacceptable or that the presentation of the biological is not acceptable; or

  (b)   the biological has changed so that it has become separate and distinct from the biological as so included; or

Note:   Section   32AB deals with when a biological is separate and distinct from other biologicals.

  (c)   the person has failed to comply with a condition to which the inclusion of the biological is subject (except a condition mentioned in subsection   32EA(1) or (3)); or

  (d)   the Secretary gives to the person a notice under section   32JA:

  (i)   that requires the person to give to the Secretary information, or to produce to the Secretary documents, relating to the biological; and

  (ii)   in respect of which section   32GB does not apply;

    and the person fails to comply with that notice within a further 14 days after the end of the period specified in that notice; or

  (e)   the person contravenes subsection   32DQ(1) or (2) in relation to the biological; or

  (f)   the biological does not conform to a standard applicable to it; or

  (fa)   the person contravenes a direction, or a condition of a direction, given to the person under subsection   42DV(1) in relation to the advertising of the biological; or

  (fb)   if the person is a body corporate--a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection   42DV(1) in relation to the advertising of the biological; or

  (g)   either of the following has not been complied with in relation to the biological:

  (i)   an applicable provision of the Therapeutic Goods Advertising Code;

  (ii)   any other requirement relating to advertising applicable under Part   5 - 1 or under the regulations.

  (2)   However, before cancelling the entry of the biological from the Register, the Secretary must:

  (a)   inform the person in writing that the Secretary proposes the cancellation and set out the reasons for it; and

  (b)   invite the person to make written submissions to the Secretary in relation to the proposed cancellation within the period specified in the notice (being not less than 28 days after the day the notice is given).

  (3)   The Secretary must not make a decision relating to the proposed cancellation until the Secretary has had regard to any submissions the person makes under paragraph   (2)(b).

  (4)   A notice under subsection   (1) is not a legislative instrument.