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null What is VHP and what happens during VHP processing?

What is VHP and what happens during VHP processing?

VHP is a Voluntary Harmonisation Procedure applied to multinational clinical drug trials conducted in EU Member States. Finland is also participating into VHP processes. Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at

Once the application has passed the VHP process, a national request is submitted in Finland. The covering letter of a national application must indicate VHP participation (VHP number) and the applicant's solemn declaration stating that the application has not been modified since the VHP. The processing time for national application submissions after the VHP is 10 days. Additional information may be requested from the documents submitted nationally to Fimea at this stage. 

For more information: /web/en/supervision/clinical_drug_trials

8 Jan 2021