Research with a medicinal product: Voluntary Harmonisation Procedure (VHP)
The Voluntary Harmonisation Procedure (VHP) is a coordinated prescreening of multinational research with medicinal products by competent authorities of various European member states. The objective of the procedure is to identify possible serious shortcomings prior to the official submission, which could lead to the study being rejected.
The VHP takes place prior to the official national submissions of the complete research file to an accredited MREC and the competent authority. If the Netherlands participates in VHP then the ethics committee is always involved in the assessment. Then there is always a VHP plus, see for further details the website of the Clinical Trial Facilitation Group. The VHP submission currently has no formal status: the VHP is an informal procedure which does not lead to an official decision. The submitting party can therefore not derive any rights from the procedure. As an official review of the entire research file is always multidisciplinary in the Netherlands, it may differ from the VHP review.
From January 2017, the Netherlands has increased its participation in the VHP in preparation for the Regulation EU 536/2014. Alongside the CCMO, the following twelve accredited medical ethics research committees (MRECs) will participate within the VHP: the eight MRECs affiliated to the university medical centres in the Netherlands (MREC AMC, CMO regio Arnhem-Nijmegen, MREC Erasmus MC, CME LUMC, MREC MUMC, MREC UMCG, MREC UMC Utrecht, MREC VUmc), the MREC of the foundation BEBO, the MEC-U, the MREC of the AVL and the MREC Brabant.
The Netherlands is able to participate within the VHP in case at the time of submission, it is indicated which MREC will assess the submitted research file within the Netherlands in the national phase. For submissions regarding studies into cell or gene therapy, unregistered vaccines, oligonucleotides, RNA interference products and non-therapeutic research with minors and incapacitated subjects the CCMO will review the submission. For all other submissions, it needs to be indicated which MREC will assess the application. If a different MREC to those listed above is to review the research file, the Netherlands will not participate in the VHP.
The VHP will be used as a pilot to gain experience into the reviewing procedure as it will be carried out after the implementation of the EU Regulation 536/2014. The participating MREC will evaluate their assessments within the pilot with the other MRECs. This means that some of the submissions will be shared with the other MRECs.
All VHP submissions will be treated confidential. The current non-disclosure agreements applicable for all members of MRECs remain fully in force as they are.
See the CTFG Guidance-document for more information and for submitting a research file for participation in the VHP.