Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 21A

Offences for making a false or misleading statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  either:

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

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

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          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.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular; and

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

Penalty:  2,000 penalty units.

             (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 makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular.

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

Offences relating to breaching a condition of registration or listing of therapeutic goods

             (5)  A person commits an offence 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; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence 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; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

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

             (8)  A person commits an offence 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; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods.

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

Offences relating to the supply of therapeutic goods in breach of authority etc.

             (9)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

                     (b)  the person supplies those goods; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7); and

                     (d)  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; and

                     (e)  the harm or injury has resulted, will result, or would result, because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7).

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A.

           (10)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

                     (b)  the person supplies those goods; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7); and

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

                     (e)  the harm or injury would be likely to result because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7).

Penalty:  2,000 penalty units.

           (11)  Subsection (10) is an offence of strict liability.

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

Offences relating to using therapeutic goods without approval etc.

           (12)  A person commits an offence if:

                     (a)  the person uses therapeutic goods; and

                     (b)  the goods are used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  the goods are not:

                              (i)  exempt goods; or

                             (ii)  listed goods; or

                            (iii)  registered goods; or

                            (iv)  goods exempt under section 18A; or

                             (v)  goods that are the subject of an approval under section 19A; and

                     (d)  the goods are not used in accordance with:

                              (i)  an approval or authority under section 19; or

                             (ii)  a condition applicable under regulations made for the purposes of subsection 19(4A); and

                     (e)  either:

                              (i)  if the person used the goods in the treatment of another person--the use of the goods has resulted in, or will result in, harm or injury to that person; or

                             (ii)  if the person used the goods solely for experimental purposes in humans--the use of the goods has resulted in, or will result in, harm or injury to any of those persons.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(8) instead: see section 53A.

           (13)  A person commits an offence if:

                     (a)  the person uses therapeutic goods; and

                     (b)  the goods are used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  the goods are not:

                              (i)  exempt goods; or

                             (ii)  listed goods; or

                            (iii)  registered goods; or

                            (iv)  goods exempt under section 18A; or

                             (v)  goods that are the subject of an approval under section 19A; and

                     (d)  the goods are not used in accordance with:

                              (i)  an approval or authority under section 19; or

                             (ii)  a condition applicable under regulations made for the purposes of subsection 19(4A); and

                     (e)  either:

                              (i)  if the person used the goods in the treatment of another person--the use of the goods, if the goods were used, is likely to result in harm or injury to that person; or

                             (ii)  if the person used the goods solely for experimental purposes in humans--the use of the goods, if the goods were used, is likely to result in harm or injury to any of those persons.

Penalty:  2,000 penalty units.

           (14)  Subsection (13) is an offence of strict liability.

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