Document ID: chunk:federal_register_of_legislation:C2022C00026:clause:4_6
Version: federal_register_of_legislation:C2022C00026
Segment Type: clause
Provision Reference: sch 4 cl 6
Character Range: 47897–49052

6  After subsection 99ACD(2)
Insert:
 (3) This section does not apply in relation to the new brand of the trigger combination item if:
 (a) all of the following apply:
 (i) the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item;
 (ii) a declaration under subsection 85(2) is in force in relation to the drug in the pharmaceutical item;
 (iii) the determination day in relation to the new brand of the trigger combination item is on or before the fifth anniversary of the declaration under subsection 85(2) being made;
 (iv) the responsible person for the new brand of the trigger combination item is the same as the responsible person for the existing listed brand of the pharmaceutical item;
 (v) the drug is not on F2; or
 (b) all of the following apply:
 (i) the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item;
 (ii) the Minister has made a determination under section 99ACEA in relation to the new brand of the trigger combination item;
 (iii) the determination under section 99ACEA has not ceased to have effect.