Document ID: chunk:federal_register_of_legislation:C2022C00026:clause:4_3
Version: federal_register_of_legislation:C2022C00026
Segment Type: clause
Provision Reference: sch 4 cl 3
Character Range: 44897–46049

3  After subsection 99ACB(3)
Insert:
 (3A) This section does not apply in relation to the new brand of the trigger item if:
 (a) the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and
 (b) the determination day in relation to the new brand of the trigger item is on or before the fifth anniversary of the drug in the pharmaceutical item being on F1; and
 (c) the responsible person for the new brand of the trigger item is the same person as the responsible person for the existing listed brand of the pharmaceutical item; and
 (d) either of the following apply:
 (i) there is not another brand of the pharmaceutical item that has the drug that is a listed brand;
 (ii) the drug is not on F2.
 (3B) This section does not apply in relation to the new brand of the trigger item if:
 (a) the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and
 (b) the Minister has made a determination under section 99ACBA in relation to the new brand of the trigger item; and
 (c) the determination under section 99ACBA has not ceased to have effect.