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THERAPEUTIC GOODS ACT 1989 - SECT 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.



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