Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 30F

             (1)  This section applies if:

                     (a)  therapeutic goods of a particular kind are exempt under section 18A; and

                     (b)  a person supplies a batch of goods of that kind; and

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

                              (i)  do not conform to a standard applicable to goods of that kind; 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 recover the goods included in that batch (except any of those goods that cannot be recovered 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 recover the goods;

                     (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 .

Written notice is not a legislative instrument

          (4A)  A written notice given to a person by the Secretary under this section is not a legislative instrument for the purposes of the Legislative Instruments Act 2003 .

Offences

          (4B)  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 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 the person failed to comply with that requirement.

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 (5) instead: see section 53A.

          (4C)  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 the goods, if the 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 the person failed to comply with that requirement.

Penalty:  2,000 penalty units.

          (4D)  Subsection (4C) is an offence of strict liability.

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

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

             (6)  For the purposes of an offence against subsection (5), strict liability applies to the following physical elements of circumstances:

                     (a)  that the notice concerned is given under subsection (2);

                     (b)  that the particular requirement concerned is a requirement mentioned in subsection (3).

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