Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99aeh
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99AEH
Character Range: 88302–90890

99AEH  Minister's powers if responsible person fails to supply, or is unable to supply, guaranteed brand

 (1) This section applies if, during the guaranteed period for a guaranteed brand of a guaranteed item, the responsible person for the guaranteed brand of the guaranteed item fails to supply, or is unable to supply, the guaranteed brand of the guaranteed item on one or more occasions.

 (2) Without limiting any power the Minister may otherwise have under this Part, the Minister may do any or all of the following:
 (a) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to the guaranteed brand of the guaranteed item;
 (b) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
 (c) refuse to make a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
 (d) if the only listed brand of a pharmaceutical item would be a brand of the pharmaceutical item of the responsible person—refuse to make:
 (i) a declaration under subsection 85(2) in relation to the drug in the pharmaceutical item; or
 (ii) a determination under subsection 85(3) in relation to the form of the pharmaceutical item; or
 (iii) a determination under subsection 85(5) in relation to the manner of administration of the pharmaceutical item.

Note: For the purposes of paragraphs (b), (c) and (d), a brand mentioned in those paragraphs may be the guaranteed brand, or a pharmaceutical item mentioned in those paragraphs may be the guaranteed item.

 (3) Without limiting the powers of the Minister under subsection (2), in exercising a power under that subsection, the Minister may have regard to:
 (a) the number of times the responsible person failed to supply, or was unable to supply:
 (i) the guaranteed brand of the guaranteed item; and
 (ii) if, in addition to the guaranteed brand of the guaranteed item, the person was also required to supply other guaranteed brands of guaranteed items—those other guaranteed brands of guaranteed items; and
 (b) the period in which those failures or inabilities occurred; and
 (c) the duration of those failures or inabilities; and
 (d) the reasons for those failures or inabilities; and
 (e) whether those reasons are, in the Minister's opinion, reasonable; and
 (f) any other matter the Minister thinks is relevant.

 (4) The refusals referred to in paragraphs (2)(c) and (d) are not legislative instruments.

Subdivision G—Consequences for other brands