Voluntary Harmonisation Procedure (VHP) submission process
It is an offer through which sponsors can obtain a harmonised assessment of an application. The actual trial must still be authorised at national level, and it is therefore not a centralised authorisation. Provided that the VHP assessment reaches consensus, the scientific content of the application must not be changed when submitted to the national competent authorities. However, it may be adapted to meet national requirements.
Clinical Consulting has experience of successful national level submission.
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