Document ID: chunk:federal_register_of_legislation:C2009A00076:clause:7_36
Version: federal_register_of_legislation:C2009A00076
Segment Type: clause
Provision Reference: sch 7 cl 36
Character Range: 58084–58706

36  After subsection 28(5A)
Insert:
 (5B) The listing of a medicine under section 26A is subject to a condition that:
 (a) each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and
 (b) each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or 28A(2).
 (5C) Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3‑3.