Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32bg
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32BG
Character Range: 38566–41197

32BG  Criminal offence and civil penalty relating to a failure to notify the Secretary about manufacturing

Criminal offence
 (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.

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.