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THERAPEUTIC GOODS ACT 1989 - SECT 21A

General criminal offences relating to this Part

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) or 26AB(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, will result in, or is likely to result in, harm or injury to any person; or

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

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:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (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) or 26AB(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.

  (4A)   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) or 26AB(2); and

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

Penalty:   100 penalty units.

  (4B)   An offence against subsection   (4A) is an offence of strict liability.

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, will result in, or is likely to result in, harm or injury to any person.

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   (8) instead: see section   53A.

Note 2:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (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.

  (8A)   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:   100 penalty units.

  (8B)   An offence against subsection   (8A) is an offence of strict liability.

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, will result in, or is likely to result in, harm or injury to any person; or

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

  (e)   the harm or injury has resulted, will result, is likely to result, would result, or 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:   Imprisonment for 5 years or 4,000 penalty units, or both.

  (9A)   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;

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

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

Penalty:   500 penalty units.

  (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;

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

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

Penalty:   100 penalty units.

  (11)   An offence against subsection   (10) is an offence of strict liability.

  (11A)   A person commits an offence if:

  (a)   the person is a health practitioner; and

  (b)   the person is included in a class of health practitioners specified in subsection   19(7A) rules; and

  (c)   the person supplies:

  (i)   therapeutic goods specified in those rules; or

  (ii)   therapeutic goods included in a class of therapeutic goods specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules; and

  (e)   either:

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

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

  (f)   the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:

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

  (ii)   the supply is not in the circumstances specified in those rules; or

  (iii)   the supply is not in accordance with the conditions specified in those rules.

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

  (11C)   A person commits an offence if:

  (a)   the person is a health practitioner; and

  (b)   the person is included in a class of health practitioners specified in subsection   19(7A) rules; and

  (c)   the person supplies:

  (i)   therapeutic goods specified in those rules; or

  (ii)   therapeutic goods included in a class of therapeutic goods specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules.

Penalty:   500 penalty units.

  (11D)   A person commits an offence if:

  (a)   the person is a health practitioner; and

  (b)   the person is included in a class of health practitioners specified in subsection   19(7A) rules; and

  (c)   the person supplies:

  (i)   therapeutic goods specified in those rules; or

  (ii)   therapeutic goods included in a class of therapeutic goods specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules.

Penalty:   100 penalty units.

  (11E)   An offence against subsection   (11D) is an offence of strict liability.

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, will result in, or 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 has resulted in, will result in, or is likely to result in, harm or injury to any of those persons.

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

  (12A)   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).

Penalty:   500 penalty units.

  (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).

Penalty:   100 penalty units.

  (14)   An offence against subsection   (13) is an offence of strict liability.


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