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Guidance 2: Fees and charges for prescription medicines

12 July 2013

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2.3 When to pay application and evaluation fees for prescription medicines

Application fees cover the administrative costs associated with an application.

Evaluation fees cover the cost of assessing the supporting information in an application.

For some applications for variation of an ARTG entry, the applicant only pays an evaluation fee, which includes the fee for administrative costs.

For the TGA to process an application the required fees must be paid at the time they become due and payable. This time depends on the application type.

Table 1: Fees at a glance - summary of s. 23 application types, timeframes and item numbers from Schedule 9 (Table 1) and Table 2: Fees at a glance - summary of s. 9D request types, timeframes and item numbers from Schedule 9 (Table 2) set out how each application type is processed by the TGA.

2.3.1 Applications under section 23 of the Act via the prescription medicines registration process

Applications lodged under the prescription medicines registration process are set out in Table 1.

The following payment provisions are prescribed for prescription medicines registration process applications by Schedule 9 of the Regulations and ss. 23(2)(a) and 24(1) of the Act:

  • an application fee equivalent to 20 per cent of the total fees must be paid when the pre-submission planning form is submitted.
  • the evaluation fee equivalent to 80 per cent of the total fees must be paid once the applicant has been notified of the TGA's acceptance of the submission and advised of the amount of the evaluation fee.

The TGA issues invoices to cover these payments.

If the evaluation is not paid within two months of an applicant being notified of the acceptance of its submission and of the amount of the evaluation fee, the application will lapse in accordance with s. 24(2)(a) of the Act.

2.3.2 Applications under section 23 of the Act for an additional trade name

The following payment provisions are prescribed by ss. 23(2)(a) and 24(1) of the Act for applications to register an additional trade name for an existing registration:

  • an application fee equivalent to 20 per cent of the total fees must be paid upon lodgement of the application.
  • the remaining evaluation fee equivalent to 80 per cent of the total fees should be paid (if not already paid) when the applicant has been notified of the TGA’s acceptance of the application.

The TGA issues invoices for the evaluation fees only. The evaluation fee must be paid within two months of its due date or the application will lapse.

2.3.2.1 Applications under section 23 of the Act for minor variations (quality related change and self assessable change)

Application or evaluation fees equivalent to 100 per cent of the total fees are payable upon lodgement of the application.

Processing or assessing an application does not commence until the required fees are paid. Refer to Table 1.

2.3.3 Requests under section 9D3 of the Act via the prescription medicines registration process

Requests lodged under the prescription medicines registration process are set out in Table 2.

The following payment provisions are prescribed for prescription medicines registration process applications by Schedule 9 of the Regulations and s9D7 of the Act:

  • an application fee equivalent to 20 per cent of the total fees must be paid when the pre-submission planning form is submitted.
  • the remaining evaluation fee equivalent to 80 per cent of the total fees should be paid when the applicant has been notified of the TGA’s acceptance of the submission.

The TGA issues invoices to cover these payments.

2.3.3.1 Other requests under 9D of the Act

Application or evaluation fees equivalent to 100 per cent of the total fees are payable upon lodgment of the request.

Processing or assessing a request does not commence until the required fees are paid. Refer to Table 2.

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