Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 19B

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

             (1)  A person commits an offence if:

                     (a)  the person:

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

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

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

                            (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; and

                     (c)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person.

Maximum 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:       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.

             (2)  A person commits an offence if:

                     (a)  the person:

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

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

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

                            (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; and

                     (c)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

Maximum penalty:    2,000 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.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (4)  A person commits an offence if:

                     (a)  the person:

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

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

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

                            (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 penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

Defence if person was not the sponsor of the goods

             (5)  It is a defence to a prosecution under subsection (1), (2) or (4) if the defendant proves that the defendant was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be.

Note:          The defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code .

Exception

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the goods; or

                             (ii)  a matter relating to the labelling or packaging of the goods; or

                            (iii)  the improper use of the goods; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the goods; or

                             (ii)  a matter relating to the labelling or packaging of the goods; or

                            (iii)  the improper use of the goods.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code .

Application of Customs Act 1901

             (7)  Where:

                     (a)  the importation or exportation of goods is an offence under subsection (1), (2) or (4); and

                     (b)  the Secretary notifies the Chief Executive Officer 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.