Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 14

Offences relating to importing goods into Australia

             (1)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; 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 goods do not conform with the standard.

Maximum 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 imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; 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 goods do not conform with the standard.

Maximum 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 imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

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

Exception

             (5)  Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do not conform with a standard applicable to the goods by reason only of matters relating to labelling or packaging.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code .

Offences relating to supplying goods for use in Australia

             (6)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; 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 goods do not conform with the standard.

Maximum 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 (9) instead: see section 53A.

             (7)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; 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 goods do not conform with the standard.

Maximum penalty:    2,000 penalty units.

             (8)  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 person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

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

Offences relating to exporting goods from Australia

           (10)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); 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 goods do not conform with the standard.

Maximum 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 (13) instead: see section 53A.

           (11)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); 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 goods do not conform with the standard.

Maximum penalty:    2,000 penalty units.

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

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

           (13)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia).

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

Decisions on whether to give consent

           (14)  The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette .

           (15)  The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision.