Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 35

             (1)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

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

                     (c)  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; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

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

                     (c)  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; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (4)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

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

                     (c)  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.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

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

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

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

                     (e)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                      (f)  the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

             (6)  Strict liability applies to paragraph (5)(c).

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (7)  A person commits an offence if:

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

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

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

                     (e)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                      (f)  the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods.

Penalty:  2,000 penalty units.

             (8)  Subsection (7) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (9)  A person commits an offence if:

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

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

                     (c)  the goods are exempt under section 18A; 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.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

           (10)  Strict liability applies to paragraph (9)(c).

Note:          For strict liability, see section 6.1 of the Criminal Code .