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Voluntary Harmonisation Procedure (VHP)

Harmonised clinical trial authorisation by EU member states after submission of a single application file – the Voluntary Harmonisation Procedure (VHP)


For detailed information on the process and requirements please refer to the reviewed guidance ‘Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications’  at the HMA homepage:

Further information can be obtained from the VHP homepage of the Paul Ehrlich Institute:

Reference Safety Information (RSI)

Information on the Reference Safety Information (RSI) for clinical trials has been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG) ofthe HMA (Heads of Medicines Agencies):


CT applications as well as substantial amendments of former VHP trials can be sent to the VHP Coordinator:

For further information on the VHP please contact or +49 6103 771810.

Additional Information

For more information