THERAPEUTIC GOODS ACT 1989 - SECT 20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification

THERAPEUTIC GOODS ACT 1989 - SECT 20A

  (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.