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

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 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.