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. 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 (9) instead: see section 53A. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (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. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (9AA) 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. Penalty: 100 penalty units. (9AB) An offence against subsection (9AA) is an offence of strict liability. Exception (9A) Subsection (6), (9) or (9AA) does not apply if: (a) the therapeutic goods are a biological; and (b) the person supplies 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 (9A): see subsection 13.3(3) of the Criminal Code. 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, 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 (13) instead: see section 53A. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (13) 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). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (13AA) 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). Penalty: 100 penalty units. (13AB) An offence against subsection (13AA) is an offence of strict liability. Exception (13A) Subsection (10), (13) or (13AA) does not apply if: (a) the therapeutic goods are a biological; and (b) the person exports 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 (13A): see subsection 13.3(3) of the Criminal Code. Decisions on whether to give consent (14) The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette or on the Department’s website. (15) The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision. (16) The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.