Document ID: chunk:federal_register_of_legislation:C2024C00632:section:20:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 20 (pt 1/2)
Character Range: 162747–165493

20  Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A
 (1B) A person commits an offence if:
 (a) the person is the sponsor of therapeutic goods for use in humans; and
 (b) the person:
 (i) imports the goods into Australia; or
 (ii) exports the goods from Australia; or
 (iii) manufactures the goods in Australia; or
 (iv) supplies the goods in Australia; and
 (c) the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:
 (i) the manufacturer of the goods;
 (ii) premises used in the manufacture of the goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
 (1BA) A person commits an offence if:
 (a) the person is the sponsor of therapeutic goods for use in humans; and
 (b) the person:
 (i) imports the goods into Australia; or
 (ii) exports the goods from Australia; or
 (iii) manufactures the goods in Australia; or
 (iv) supplies the goods in Australia; and
 (c) the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:
 (i) the manufacturer of the goods;
 (ii) premises used in the manufacture of the goods.
Penalty: 100 penalty units.
 (1BB) An offence against subsection (1BA) is an offence of strict liability.
 (1C) For the purposes of paragraphs (1B)(c) and (1BA)(c):
 (a) a manufacturer is properly notified to the Secretary if:
 (i) the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or
 (ii) the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and
 (b) premises are properly notified to the Secretary if:
 (i) the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or
 (ii) the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.
 (2A) A person commits an offence if:
 (a) the person imports therapeutic goods into Australia; and
 (b) the goods are exempt under section 18A; and
 (c) the importation breaches a condition of the exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
 (2B) Strict liability applies to paragraph (2A)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
 (2C) A person commits an offence if:
 (a) the person imports therapeutic goods into Australia; and
 (b) the goods are exempt under section 18A; and
 (c) the importation breaches a condition of the exemption.
Penalty: 60 penalty units.
 (2D) An offence under subsection (2C)