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Voluntary Harmonisation Procedure (VHP)

Voluntary Harmonisation Procedure (VHP)

In 2014 a new European Clinical Trial Regulation (ECTR, EU no. 536/2014) was adopted. It is as yet unknown when this Regulation will enter into force. In the Netherlands, experience is being gained with the new way of working via a VHP pilot. The MREC Utrecht is taking part in this pilot. In the cover letter you can indicate your preference for MREC Utrecht as your review committee for the Netherlands.

VHP review pilot uitklapper, klik om te openen

In 2014 a new European Clinical Trial Regulation (ECTR) (EU no. 536/2014) was adopted. To prepare for this Regulation, a pilot has been initiated in the Netherlands in which a number of MRECs and the CCMO are gaining experience with the procedure that will apply under this Regulation. For this pilot, use is being made of the Voluntary Harmonisation Procedure (VHP).  The VHP concerns the simultaneous review by several EU countries of a number of documents from a file relating to research with a medicinal product, before it is submitted to the reviewing committees in the individual countries (in the Netherlands: to an MREC for review under the WMO). The VHP relates to the following documents: Protocol, Investigator’s Brochure, and IMPD.

The MREC Utrecht is taking part in this pilot. For the MREC Utrecht it is important to be able to practice with the procedure that will apply under the new legislation as much as possible. In the cover letter for the VHP, applicants can indicate which is their preferred MREC in the Netherlands. Often this will be the MREC of the institution where the research will actually be conducted.

More information

Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology

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