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NATIONAL HEALTH ACT 1953 - SECT 99AEK

Minister may revoke or vary formulary determination if guaranteed brand delisted

    Without limiting the power of the Minister under section   85AB, the Minister may, by legislative instrument, revoke or vary a determination under section   85AB 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)   the remaining item is a combination item; and

  (e)   the drug in the remaining item was not on F1 or F2 on the day before subsection   99AEC(2) began to apply to the delisted brand of the existing item.


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