Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:7_184
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 7 cl 184
Character Range: 191076–191770

184  After subsection 35(4)
Insert:
 (4A) 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 or 32CB); 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: 100 penalty units.
 (4B) An offence against subsection (4A) is an offence of strict liability.