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THERAPEUTIC GOODS ACT 1989 - SECT 32CJ

Criminal offences and civil penalty for biologicals not conforming to standards etc.

             (1)  This section applies if:

                     (a)  a biological is exempt under section 32CB; and

                     (b)  a person supplies a batch of the biologicals; and

                     (c)  the Secretary is satisfied that the biologicals included in that batch:

                              (i)  do not conform to a standard applicable to the biologicals; or

                             (ii)  are otherwise not fit to be used for their intended purposes.

             (2)  The Secretary may, by written notice given to the person, require the person to take steps to recall the biologicals included in that batch (except any of those biologicals that cannot be recalled because they have been administered to, or applied in the treatment of, a person).

             (3)  The notice may specify one or more of the following requirements:

                     (a)  the steps to be taken to recall the biologicals;

                     (b)  the manner in which the steps are to be taken;

                     (c)  a reasonable period within which the steps are to be taken.

             (4)  The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette or on the Department's website.

Notice is not a legislative instrument

             (5)  A notice given under subsection (2) is not a legislative instrument.

Offences

             (6)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  either:

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

                             (ii)  the use of any of the biologicals, if any of the biologicals 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 the person failed to comply with that requirement.

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

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

             (7)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  the use of any of the biologicals, if any of the biologicals 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 the person failed to comply with that requirement.

Penalty:  2,000 penalty units.

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

             (8)  An offence against subsection (7) is an offence of strict liability.

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

             (9)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement.

Penalty:  60 penalty units.

           (10)  An offence against subsection (9) is an offence of strict liability.

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

Civil penalty

           (11)  A person contravenes this subsection if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person does not comply with the requirement.

Maximum civil penalty:

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

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

Saving of other laws

           (12)  This section is not intended to exclude or limit the operation of any other law of the Commonwealth or any law of a State or Territory.



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