Document ID: chunk:federal_register_of_legislation:C2024C00632:section:20a
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 20A
Character Range: 165596–167168

20A  Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification
 (1) A person contravenes this section if:
 (a) the person does any of the following:
 (i) imports therapeutic goods into Australia;
 (ii) exports therapeutic goods from Australia;
 (iii) manufactures therapeutic goods in Australia;
 (iv) supplies therapeutic goods in Australia; and
 (b) the person is the sponsor of the goods for use in humans; and
 (c) the person has not, at or before the time of the importation, exportation, 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 civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Meaning of properly notified
 (2) For the purposes of paragraph (1)(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.