Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32bg:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32BG (pt 1/2)
Character Range: 412926–415669

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

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