Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99aej
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99AEJ
Character Range: 92642–93629

99AEJ  Minister may determine drug is on F1 if guaranteed brand delisted

  The Minister may, by legislative instrument, determine that a listed drug is on F1 if:
 (a) under section 99AEH, the Minister revokes or varies a determination under subsection 85(6) in relation to a brand (the delisted brand) of a pharmaceutical item (the existing item); and
 (b) before the revocation or variation came into force, subsection 99AEC(2) applied to the delisted brand of the existing item; and
 (c) after the revocation or variation comes into force, there is only one listed brand of a pharmaceutical item (the remaining item) that is bioequivalent or biosimilar to the delisted brand of the existing item; and
 (d) apart from paragraph 85AB(4)(c), the drug in the remaining item satisfies the criteria for F1 referred to in subsection 85AB(4); and
 (e) the drug in the remaining item was on F1 on the day before subsection 99AEC(2) began to apply to the delisted brand of the existing item.