Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:43aah:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 43AAH (pt 2/3)
Character Range: 406130–408663

public health for the entry in relation to the goods to remain on the Register; and
 (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.
 (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:
 (a) the population who use the goods;
 (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;
 (c) any health risks to the population who use the goods that may be associated with:
 (i) obtaining the goods through alternative means; or
 (ii) the use of alternative goods;
 (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.
 (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).

Notice of decision
 (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.
 (11) If the decision is to refuse to waive the charge for the financial year, the notice under subregulation (10) must:
 (a) set out the reasons for the decision; and
 (b) specify the date on which the charge for the financial year becomes payable.

Period during which decision has effect
 (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.
 (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.

Subdivision 3—Charges for licensing