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 .