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. > Note: For strict liability, see section 6.1 of the Criminal Code.