Refunds

With few exceptions, the TGA's regulatory fees and charges are non-refundable and non-transferable.

Key points

• An application fee (or 'screening fee') is non-refundable.
• An application fee will be transferred where an application is withdrawn and resubmitted (unaltered) at the request of the TGA.
• Evaluation fees are non-refundable following acceptance by the TGA, unless the applicable fee has been waived or reduced after payment has been made (see below).
• Annual charges for entries on the Australian Register of Therapeutic Goods (the Register) and for manufacturing licences cannot be refunded following payment where the entry or licence has been in force at any time during the financial year.

The application process

Sponsors and manufacturers should carefully review each application prior to submission to ensure that it is correct in all respects. This will avoid paying undue fees.

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.

Evaluation fees

Evaluation fees are non-refundable following acceptance by the TGA, however 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.

Annual charges

• Annual charges are payable for a therapeutic good that has been entered on the Register, and manufacturing licences that have been in force at any time during the financial year to which the charge relates.
• The Therapeutic Goods (Charges) Act 1989, (the Charges Act) does not allow the TGA any discretion to reduce annual charges.
• The Therapeutic Goods Legislation Amendment (Annual Charges Exemption) Regulation 2015 provides for the waiver of the annual charge under exceptional circumstances.
• An annual charge is non-refundable following receipt of payment.
• Licences approved at any point during a year incur the full annual charge.
• New entries approved at any point during a year will automatically qualify for an annual charge exemption (ACE) until the product generates turnover. There is no basis for a pro-rata of an annual charge.
• Entries and licences cancelled during the year remain liable for payment of the annual charge for that year.

An annual charge is not payable in relation to an entry on the Register that has an ACE in place. The ACE is only applicable until the entry generates turnover.

The low value turnover (LVT) scheme has been replaced by the Annual Charge Exemption (ACE) scheme commencing 1 July 2015. For information on the new ACE scheme, including the transitional arrangements in place for entries previously granted LVT exemptions, see: ACE Scheme.

Forms

Not applicable.

Assistance

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 or 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.
• Part 7 provides information on annual charge exemptions and waivers.

Therapeutic Goods (Charges) Act 1990

• Section 4 establishes annual charges.

Therapeutic Goods (Charges) Regulations 1990

• Rates of annual charges.