Refunds
April 2007
With few exceptions, the TGA's regulatory fees and charges are non refundable and non-transferable.
Key points
- Application fees are non-refundable.
- Evaluation fees are non-refundable following acceptance by the TGA, unless the applicable fee has been waived or reduced after payment has been made.
- An application fee (or 'screening fee') is retained by the TGA for screening submissions that are subsequently withdrawn by a Sponsor or rejected by the TGA prior to acceptance for evaluation.
- An applicaiton fee will be transferred where an application is withdrawn and resubmitted (unaltered) at the request of the TGA.
- Recognising the administrative cost of processing refunds, an overpayment of an application of evaluation fee will only be returned on request or where it exceeds $100.
- Annual charges for entries on the ARTG and for manufacturing licences cannot be refunded following payment where the entry or licence has been in force during the relevant year.
Procedures
Sponsors and manufacturers are expected to take care in making applications and submissions to avoid the loss of fees and charges.
Sponsors and Manufacturers should carefully review each application prior to submission to ensure that it is correct in all respects.
Application fees may be transferred to another application where a submission is unable to be processed due to an error in a TGA online system or as a result of following instructions from the TGA.
An application (screening) fee will apply to an evaluation submitted to the Drug Safety and Evaluation Branch that has been withdrawn by a Sponsor or has been rejected by the TGA prior to acceptance for evaluation.
- The screening fee will be 20% of the applicable evaluation fee up to a maximum amount prescribed in the Regulations.
- The balance of an evaluation fee will be returned after deducting the screening fee retained, within 45 days after withdrawal or rejection.
Evaluation fees are non-refundable following acceptance by the TGA.
A refund may be made where the Secretary has determined a reduction or waiver of an evaluation fee should be made in accordance with the Regulations.
An annual charge is non refundable following receipt of payment. Annual charges are payable in respect of a therapeutic good that has been entered on the ARTG, and manufacturing licences that have been in force, for any period of a financial year.
- New entries and licences approved during a year attract the full annual charge.
- Entries and licences cancelled during the year remain liable for payment of the full annual charge.
- An annual charge is not payable in relation to a product entry on the ARTG that has been declared to be of low value and low volume. Application forms are unable to be accepted after the end of the relevant financial year.
- The TGA has no discretion to reduce or waiver annual charges under the Therapeutic Goods (Charges) Act.
Forms
Not applicable
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
Therapeutic Goods Act 1989
- Paragraph 63(2)(h) provides that the Regulations may prescribe fees.
- Paragraph 63(3)(b) provides for the refund, reduction or waiving of fees and charges in cases identified in the Regulations.
Therapeutic Goods Regulations 1990
- Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990 sets out the table of fees payable.
- Item 2(ba) of Schedule 9 sets out the application fees retained for screening a submission prior to acceptance for evaluation.
- Regulation 45 provides that the Secretary may waive or reduce fees specified in Schedule 9 under certain circumstances.
Therapeutic Goods (Charges) Act 1990
- Section 4 establishes annual charges.
Therapeutic Goods (Charges) Regulations 1990
- Rates of annual charges.