Document ID: chunk:federal_register_of_legislation:C2024C00632:section:21b
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 21B
Character Range: 178360–180753

21B  General civil penalties relating to this Part

Civil penalty for making a false or misleading statement
 (1) A person contravenes this subsection if the person, in or in connection with a certification of any matter under subsection 26A(2) or 26AB(2), makes a statement that is false or misleading in a material particular.
Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Civil penalty relating to breaching a condition of registration or listing of therapeutic goods
 (2) A person contravenes this subsection if:
 (a) therapeutic goods are registered or listed in relation to the person; and
 (b) the person does an act or omits to do an act that breaches a condition of the registration or listing of the goods.
Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Civil penalty for falsely representing therapeutic goods
 (3) A person contravenes this subsection if:
 (a) the person represents therapeutic goods that are not included in the Register as being so included; or
 (b) the person represents therapeutic goods that are not exempt goods as being exempt goods; or
 (c) the person represents therapeutic goods that are not goods exempt under section 18A as being goods exempt under that section; or
 (d) the person represents therapeutic goods that are included in one part of the Register as being included in another part of the Register; or
 (e) the person represents therapeutic goods that are not the subject of an approval or authority under section 19 as being the subject of such an approval or authority; or
 (f) the person represents therapeutic goods that are not the subject of an approval under section 19A as being the subject of such an approval.
Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Civil penalty for advertising therapeutic goods for an indication
 (4) A person contravenes this subsection if:
 (a) the person, by any means, advertises therapeutic goods for an indication; and
 (b) the therapeutic goods are included in the Register; and
 (c) the indication is not an indication accepted in relation to that inclusion.
Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.