14Criminal offences for importing, supplying or exporting goods that do not comply with standards

14 Criminal offences for importing, supplying or exporting goods that do not comply with standards

Offences relating to importing goods into Australia (1) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging); and (d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and (e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the goods do not conform with the standard.

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: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging).

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

(4A) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging).

Penalty: 100 penalty units.

(4B) An offence against subsection (4A) is an offence of strict liability. Exception (5A) Subsection (1), (4) or (4A) does not apply if: (a) the therapeutic goods are a biological; and (b) the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

Note: A defendant bears an evidential burden in relation to the matter in subsection (5A): see subsection 13.3(3) of the Criminal Code.

Offences relating to supplying goods for use in Australia (6) 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) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and (e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the goods do not conform with the standard.