Voluntary Harmonisation Procedure (VHP) submission process

The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

The assessment is conducted and coordinated between the national competent authorities (medicines agencies) of the countries in which the trial is to take place following which the application is submitted to the countries involved.

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.