Commonwealth Consolidated Acts

[Index] [Table] [Search] [Search this Act] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS ACT 1989 - SECT 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.



AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback