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Assessed listed medicines evidence guidelines
Version 1.1, August 2018
10. Timeframes and fees
The TGA has established statutory evaluation timeframes for pre-market evaluation of products submitted under section 26AE of the Act (assessed listed medicines). These are provided below.
|Application category||Notification of preliminary assessment
The above evaluation timeframes:
- apply to working days only, and exclude public holidays and weekends;
- exclude where the evaluation clock has stopped e.g.
- for the time taken by the applicant to provide responses to formal requests for information made by the Secretary under section 31;
- when the applicant and TGA agree to a mutual stop clock.
- only commence once an application has been accepted for evaluation and following payment of the evaluation fee. The delegate of the Secretary will notify an applicant in writing within 40 working days of receiving the application whether the application has passed preliminary assessment; and
Although the TGA is required to complete the assessment within the specified timeframes, applicants should not presuppose the outcome of an application. The Commonwealth and its representatives are not liable to a person for loss, damage or injury of any kind that is caused by or arises from a failure to decide an application within the specified timeframe.
The fee structure aligns with the application categories and associated evaluation workload. There are two components to the fees for an application – an administrative application fee, and an evaluation fee.
- The application fee cannot be waived, reduced or refunded.
- If the application is withdrawn before it enters the evaluation step in the process, the evaluation fee will be refunded. The application fee will not be refunded.
- In exceptional circumstances, the Secretary may waive or reduce an evaluation fee if there is information to enable an evaluation to be abridged.