Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 20

          (1B)  A person commits an offence if:

                     (a)  the person is the sponsor of therapeutic goods for use in humans; and

                     (b)  the person:

                              (i)  imports the goods into Australia; or

                             (ii)  exports the goods from Australia; or

                            (iii)  manufactures the goods in Australia; or

                            (iv)  supplies the goods in Australia; and

                     (c)  the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the goods;

                             (ii)  premises used in the manufacture of the goods.

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

       (1BA)  A person commits an offence if:

                     (a)  the person is the sponsor of therapeutic goods for use in humans; and

                     (b)  the person:

                              (i)  imports the goods into Australia; or

                             (ii)  exports the goods from Australia; or

                            (iii)  manufactures the goods in Australia; or

                            (iv)  supplies the goods in Australia; and

                     (c)  the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the goods;

                             (ii)  premises used in the manufacture of the goods.

Penalty:  100 penalty units.

        (1BB)  An offence against subsection (1BA) is an offence of strict liability.

          (1C)  For the purposes of paragraphs (1B)(c) and (1BA)(c):

                     (a)  a manufacturer is properly notified to the Secretary if:

                              (i)  the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

                     (b)  premises are properly notified to the Secretary if:

                              (i)  the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.

          (2A)  A person commits an offence if:

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

                     (b)  the goods are exempt under section 18A; and

                     (c)  the importation breaches a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

          (2B)  Strict liability applies to paragraph (2A)(b).

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

          (2C)  A person commits an offence if:

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

                     (b)  the goods are exempt under section 18A; and

                     (c)  the importation breaches a condition of the exemption.

Penalty:  60 penalty units.

          (2D)  An offence under subsection (2C) is an offence of strict liability.

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