Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_14:p2
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 14 (pt 2/3)
Character Range: 6056–8597

person supplies therapeutic goods for use in Australia; and
 (b) the goods are supplied without the consent in writing of the Secretary; and
 (c) the goods do not conform with a standard applicable to the goods; and
 (d) 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; and
 (e) the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard.

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

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

 (7) A person commits an offence if:
 (a) the person supplies therapeutic goods for use in Australia; and
 (b) the goods are supplied without the consent in writing of the Secretary; and
 (c) the goods do not conform with a standard applicable to the goods; and
 (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and
 (e) the harm or injury would be likely to result because the goods do not conform with the standard.

Maximum penalty: 2,000 penalty units.

 (8) Subsection (7) is an offence of strict liability.

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

 (9) A person commits an offence if:
 (a) the person supplies therapeutic goods for use in Australia; and
 (b) the goods are supplied without the consent in writing of the Secretary; and
 (c) the goods do not conform with a standard applicable to the goods.

Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting goods from Australia

 (10) A person commits an offence if:
 (a) the person exports therapeutic goods from Australia; and
 (b) the goods are exported without the consent in writing of the Secretary; and
 (c) the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); and
 (d) 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; and
 (e) the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard.

Maximum penalty: Imprisonment for 5 years or 4,000