14ACivil penalties for importing, supplying or exporting goods that do not comply with standards

#### 14A Civil penalties for importing, supplying or exporting goods that do not comply with standards Civil penalty relating to importing goods into Australia (1) A person contravenes this subsection if: (a) the person imports therapeutic goods into Australia; and (b) the person does not have 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). Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Exception (1A) Subsection (1) 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. Civil penalty relating to supplying goods for use in Australia (2) A person contravenes this subsection if: (a) the person supplies therapeutic goods for use in Australia; and (b) the person does not have the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Exception (2A) Subsection (2) 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. Civil penalty relating to exporting goods from Australia (3) A person contravenes this subsection if: (a) the person exports therapeutic goods from Australia; and (b) the person does not have 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). Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Exception (3A) Subsection (3) 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. Decisions on whether to give consent (4) 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. (5) 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. (6) 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.