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We have developed new processes consistent with the suggestions in the IEA report. Do we need output evidence to demonstrate this before being granted a licence?

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We have developed new processes consistent with the suggestions in the IEA report. Do we need output evidence to demonstrate this before being granted a licence?

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As a general rule, yes. Evidence of output documentation is an integral part of the assessment process. Nevertheless, the department recognises that there are particular policies and procedures that may not be implemented within the assessment timeframe. In these instances you may be able to submit a response of Data Not Available (DNA); however it is recommended that you contact your CRO for assistance when determining which output documents can be omitted.

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