THERAPEUTIC GOODS ACT 1989 - SECT 19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods

THERAPEUTIC GOODS ACT 1989 - SECT 19D

Civil penalty relating to importing, exporting, manufacturing or supplying goods for use in humans

  (1)   A person contravenes this subsection if:

  (a)   the person does any of the following:

  (i)   imports into Australia therapeutic goods for use in humans;

  (ii)   exports from Australia therapeutic goods for use in humans;

  (iii)   manufactures in Australia therapeutic goods for use in humans;

  (iv)   supplies in Australia therapeutic goods for use in humans; and

  (b)   none of the following subparagraphs applies in relation to the goods:

  (i)   the goods are registered goods or listed goods in relation to the person;

  (ii)   the goods are exempt goods;

  (iii)   the goods are exempt under section   18A;

  (iv)   the goods are the subject of an approval or authority under section   19;

  (v)   the goods are the subject of an approval under section   19A.

Maximum civil penalty:

  (a)   for an individual--5,000 penalty units; and

  (b)   for a body corporate--50,000 penalty units.

Note:   A person may commit an offence against subsection   20(2A) or (2C), or may contravene section   22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section   18A.

Exception if person was not the sponsor of the goods

  (2)   Subsection   (1) does not apply if the person proves that he or she was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be.

Civil penalty relating to the importing of registered or listed goods

  (3)   A person contravenes this subsection if:

  (a)   therapeutic goods are registered or listed in relation to the person; and

  (b)   the person imports the goods into Australia; and

  (ba)   the person does not have the consent in writing of the Secretary; and

  (c)   the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner before the goods are supplied in Australia.

Maximum civil penalty:

  (a)   for an individual--200 penalty units; and

  (b)   for a body corporate--2,000 penalty units.

Civil penalty relating to the supply of registered or listed goods

  (4)   A person contravenes this subsection if:

  (a)   therapeutic goods are registered or listed in relation to the person; and

  (b)   the person supplies the goods in Australia; and

  (ba)   the person does not have the consent in writing of the Secretary; and

  (c)   the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner.

Maximum civil penalty:

  (a)   for an individual--200 penalty units; and

  (b)   for a body corporate--2,000 penalty units.

Application of Customs Act 1901

  (5)   Where:

  (a)   the importation or exportation of goods contravenes subsection   (1); and

  (b)   the Secretary notifies the Comptroller - General of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section   229 of that Act because they were:

  (c)   prohibited imports within the meaning of that Act; or

  (d)   prohibited exports within the meaning of that Act;

as the case requires.

Decisions on whether to give consent

  (6)   The Secretary must, as soon as practicable after making a decision to give a consent mentioned in subsection   (3) or (4), cause particulars of the decision to be published on the Department's website.

  (7)   The Secretary must, within 28 days after making a decision to refuse to give a consent mentioned in subsection   (3) or (4), notify the applicant in writing of the decision and of the reasons for the decision.