Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 45AA

Payment of fees in instalments

  (1)   Subject to subregulation   (7), the Secretary may allow the amount of a fee payable under item   4, 5, 6, 10 or 11 in Schedule   9A to be paid in instalments, if:

  (a)   the applicant has applied in writing to pay the amount in instalments; and

  (b)   the amount payable exceeds $10,000; and

  (c)   the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and

  (d)   any information or material to which subregulation   (3) applies has been provided to the Secretary.

  (2)   An application under subregulation   (1) must:

  (a)   state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and

  (b)   have with it documents or other material in support of the statement.

  (3)   If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph   2(b), the Secretary may require the applicant to provide the information or material to the Secretary.

  (4)   If the Secretary approves an application under subregulation   (1):

  (a)   50% of the fee is due for payment before the commencement of the evaluation of the application; and

  (b)   25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph   (a) is due for payment; and

  (c)   the remaining 25% is due for payment:

  (i)   if the application for evaluation is withdrawn--at the time of withdrawal; or

  (ii)   if the Secretary refuses the application to include the biological in the Register--when the applicant is notified under section   32DG of the Act; or

  (iii)   if the evaluation is completed--before the biological is included in the Register.

  (5)   If:

  (a)   the Secretary approves an application under subregulation   (1); and

  (b)   any amount of the fee payable by the applicant is not paid when it becomes due for payment;

the balance of the fee becomes due for payment.

  (6)   If the Secretary receives an application under subregulation   (1), he or she must:

  (a)   give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and

  (b)   if the application is approved--include with the notice information about the amounts of the instalments and when the instalments are due for payment.

  (7)   This regulation does not apply while another evaluation fee, or an assessment fee payable under section   41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.

 


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