20Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A

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) is an offence of strict liability.