Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_19b:p1
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 19B (pt 1/3)
Character Range: 15179–17862

19B  Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods

Offences relating to importing, exporting, manufacturing or supplying goods for use in humans

 (1) A person commits an offence if:
 (a) the person:
 (i) imports into Australia therapeutic goods for use in humans; or
 (ii) exports from Australia therapeutic goods for use in humans; or
 (iii) manufactures in Australia therapeutic goods for use in humans; or
 (iv) supplies in Australia therapeutic goods for use in humans; and
 (b) none of the following subparagraphs applies in relation to the goods:
 (i) the goods are registered goods or listed goods in relation to the person;
 (ii) the goods are exempt goods;
 (iii) the goods are exempt under section 18A;
 (iv) the goods are the subject of an approval or authority under section 19;
 (v) the goods are the subject of an approval under section 19A; and
 (c) either:
 (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or
 (ii) the use of the goods, if the goods were used, would result in harm or injury to any person.

Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

 (2) A person commits an offence if:
 (a) the person:
 (i) imports into Australia therapeutic goods for use in humans; or
 (ii) exports from Australia therapeutic goods for use in humans; or
 (iii) manufactures in Australia therapeutic goods for use in humans; or
 (iv) supplies in Australia therapeutic goods for use in humans; and
 (b) none of the following subparagraphs applies in relation to the goods:
 (i) the goods are registered goods or listed goods in relation to the person;
 (ii) the goods are exempt goods;
 (iii) the goods are exempt under section 18A;
 (iv) the goods are the subject of an approval or authority under section 19;
 (v) the goods are the subject of an approval under section 19A; and
 (c) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

Maximum penalty: 2,000 penalty units.

Note: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.