Document ID: chunk:federal_register_of_legislation:C2004A01124:clause:1_26
Version: federal_register_of_legislation:C2004A01124
Segment Type: clause
Provision Reference: sch 1 cl 26
Character Range: 25846–27201

26  After subsection 20(1A)
Insert:

 (1B) A person is guilty of 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.

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

 (1C) For the purposes of paragraph (1B)(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.