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THERAPEUTIC GOODS ACT 1989 - SECT 35A

Civil penalties relating to manufacturing therapeutic goods

             (1)  A person contravenes this subsection if:

                     (a)  the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are not exempt under section 18A or 32CB; and

                     (d)  none of the following applies:

                              (i)  the goods are exempt goods;

                             (ii)  the person is an exempt person in relation to the manufacture of the goods;

                            (iii)  the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

             (2)  A person contravenes this subsection if:

                     (a)  the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are exempt under section 18A or 32CB; and

                     (d)  the person is not the holder of a licence that:

                              (i)  is in force; and

                             (ii)  authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.



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