Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953 - SECT 99ACEA

  (1)   If:

  (a)   a brand of a pharmaceutical item (the trigger combination item ) is a combination item; and

  (b)   the brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item; and

  (c)   a declaration under subsection   85(2) is in force in relation to the drug in the pharmaceutical item; and

  (d)   the Minister is satisfied that the determination day in relation to the brand of the trigger combination item is after the fifth anniversary, and before the tenth anniversary, of the declaration under subsection   85(2) being made;

the Minister may determine, by notifiable instrument, that the brand of the trigger combination item is not a new brand for the purposes of section   99ACD.

  (2)   If the Minister makes a determination under this section in relation to the brand of the trigger combination item, it must be made before the determination day in relation to the brand of the trigger combination item.

  (3)   In making a determination, the Minister may have regard to:

  (a)   any advice given by the Pharmaceutical Benefits Advisory Committee; and

  (b)   any information provided by the responsible person for the brand of the trigger combination item; and

  (c)   any other matter that the Minister considers relevant.

  (4)   A determination made under this section ceases to have effect on whichever is the earliest of the following:

  (a)   the tenth anniversary of the declaration under subsection   85(2) being made;

  (b)   the day that the drug is on F2.

  (5)   In this section:

"determination day" has the same meaning as in paragraph   99ACD(1)(a).