Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 32BG

Criminal offences

  (1)   A person commits an offence if:

  (a)   the person:

  (i)   imports a biological into Australia for use in humans; or

  (ii)   exports a biological from Australia for use in humans; or

  (iii)   manufactures a biological in Australia for use in humans; or

  (iv)   supplies a biological in Australia for use in humans; and

  (b)   the person is the sponsor of the biological; and

  (c)   the person is not exempt under subsection   32CA(1) in relation to the biological and the biological is not exempt under subsection   32CA(2); and

  (d)   the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

  (i)   the manufacturer of the biological;

  (ii)   the premises used in the manufacture of the biological.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

  (1A)   A person commits an offence if:

  (a)   the person:

  (i)   imports a biological into Australia for use in humans; or

  (ii)   exports a biological from Australia for use in humans; or

  (iii)   manufactures a biological in Australia for use in humans; or

  (iv)   supplies a biological in Australia for use in humans; and

  (b)   the person is the sponsor of the biological; and

  (c)   the person is not exempt under subsection   32CA(1) in relation to the biological and the biological is not exempt under subsection   32CA(2); and

  (d)   the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

  (i)   the manufacturer of the biological;

  (ii)   the premises used in the manufacture of the biological.

Penalty:   100 penalty units.

  (1B)   An offence against subsection   (1A) is an offence of strict liability.

Civil penalty

  (2)   A person contravenes this subsection if:

  (a)   the person:

  (i)   imports a biological into Australia for use in humans; or

  (ii)   exports a biological from Australia for use in humans; or

  (iii)   manufactures a biological in Australia for use in humans; or

  (iv)   supplies a biological in Australia for use in humans; and

  (b)   the person is the sponsor of the biological; and

  (c)   the person is not exempt under subsection   32CA(1) in relation to the biological and the biological is not exempt under subsection   32CA(2); and

  (d)   the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

  (i)   the manufacturer of the biological;

  (ii)   the premises used in the manufacture of the biological.

Maximum civil penalty:

  (a)   for an individual--5,000 penalty units; and

  (b)   for a body corporate--50,000 penalty units.

Definition

  (3)   For the purposes of this section:

  (a)   a manufacturer is properly notified to the Secretary if:

  (i)   the manufacturer was nominated, as a manufacturer of the biological, in an application for inclusion of the biological in the Register; or

  (ii)   the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the biological; and

  (b)   premises are properly notified to the Secretary if:

  (i)   the premises were nominated, as premises used in the manufacture of the biological, in an application for inclusion of the biological in the Register; or

  (ii)   the Secretary was subsequently informed in writing that the premises are used in the manufacture of the biological.