Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 32JB

             (1)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                    (aa)  the person is covered by paragraph 32JA(1)(b) or (c); and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

Note:          Failure to comply with the notice might also lead to suspension or cancellation of the entry of a biological in the Register (see Divisions 6 and 7).

          (1A)  Subsection (1) does not apply if the person has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (1A): see subsection 13.3(3) of the Criminal Code .

          (1B)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person is covered by paragraph 32JA(1)(b) or (c); and

                     (c)  the person fails to comply with the notice.

Penalty:  100 penalty units.

          (1C)  An offence against subsection (1B) is an offence of strict liability.

          (1D)  Subsection (1B) does not apply if the person has a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (1D): see subsection 13.3(3) of the Criminal Code .

             (2)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA in relation to a biological; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

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

                     (d)  either:

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

                             (ii)  the use of the biological, if the biological 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 (5) instead: see section 53A.

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

             (5)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

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

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

             (6)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

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

Penalty:  100 penalty units.

             (7)  An offence against subsection (6) is an offence of strict liability.