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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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