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Guidance 2: Fees and charges for prescription medicines
2.8 When application fees are refunded for prescription medicines
2.8.1 Refund of application fees for incorrect or ineffective submissions
The Act contains no provisions to refund application fees to applicants after the application has been received by the TGA. Applicants should therefore take care before submitting applications to avoid the loss of application fees. The TGA retains application fees even if:
- the application is withdrawn before it has been accepted
- the application is deemed ineffective by the TGA.
2.8.2 Refund of evaluation fees for effective submissions
For applications submitted via the prescription medicines registration process under ss. 9D(3) or s. 23 of the Act, the TGA must complete the evaluation within the timeframes set out in rr. 16C and 16D, respectively.
If the evaluation exceeds this timeframe, the TGA must refund 25 per cent of the evaluation Therapeutic Goods Act 1989 (for example, evaluation fee)." class="hovertext">fee to the applicant, as specified in s. 24D of the Act and r. 43AA. Please note that these provisions only relate to the evaluation fee and not the application fee. The full application fee will be retained by the TGA.
There is no reduction in evaluation fee for other applications that exceed the statutory timeframe prescribed in rr. 16F and 16G.
However, for a minor variation to which r. 16F or r. 16G applies, the delegate will be deemed to have approved the application if the application exceeds the statutory timeframe.