Voluntary Harmonisation Procedure (VHP)
Harmonized authorisation by competent authorities of clinical trials in two or more EU member states after submission of a single application file (VHP)
Since December 2014, a new modified Voluntary Harmonisation Procedure (VHP) Guideline version 3.2 for all clinical trials of medicinal products can be used. A single application submitted to the Clinical Trials Facilitation Group (CTFG) in English will be evaluated in a single procedure together by the competent authorities of those Member States where the clinical trial will be carried out. A single NCA will take over the duty of a Reference NCA (Rapporteur). The sponsor of a CTA is required to propose one of the participating NCAs as a Ref-NCA. This proposal is not binding for the MS. In the case of no Ref-NCA in spite of the Sponsor proposal and internal selection mechanisms at the end of the validation phase, a VHP will not be performed(see Guidance for more details). After the successful process of finding a Ref-NCAs scientific questions on the protocol and the investigational medicinal product will thus be clarified together. Subsequently, the clinical trial authorisation by each competent involved will be generally provided within 10 days.
The main criteria and improvements of the new procedure are:
- The clinical trial is planned to be carried out in two or more Members States.
- A Second Round/wave for the inclusion of new Member States after a VHP under defined conditions are introduced
- Subsequent substantial amendments will also be handled by the VHP.
- Rules for conditions after a VHP or a VHP-substantial amendment as well as on potential fees have been clarified.
- The harmonized scientific assessment will start immediately following submission of a single application (written in English).
- The proposal of a Ref-NCA by the sponsor is mandatory
- Changes of the list of participating Member States and responsibilities
- Introduction of participation of Ethics Committees for some participating Member states (VHP-Plus)
The participation of Ethics Committees is possible for some participating member states. Inclusion of Ethics Committees is only possible for initial applications.
A list of participating member states for which Ethics Commitees are eligible can be found here:
Please contact the national competent authorities for details.
A direct contact between EC and applicant is neither foreseen nor necessary in VHP.
For Germany applicants are invited to contact the VHP administrator for details if they are interested to involve Ethics Committees in a VHP. This involves only the assessment of the benefit/risk, investigators brochure and study protocol in the VHP and no other documents.
A list (status 01.02.2015) of German Ethics Committees that will potentially participate in the VHP can be found here:
This list will be updated regularly.
Application for VHP
Application for VHP can be sent to: VHP-CTFG@VHP-CTFG.eu
Further information on the VHP can be requested under VHP-CTFG@VHP-CTFG.eu or phone +49 6103 771810.
Please click on the link below to view the revised Version 4 of the "Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications" and list of participating Member States and responsibilites:
List of participating member states in VHP, January 2017 (pdf, 105 KB, File does not meet accessibility standards.)
VHP-plus: List of Participating National Competent Authorities (pdf, 87 KB, File does not meet accessibility standards.)
Results and figures
Results and figures on the Voluntary Harmonisation Procedures can be found on the Webpages of the HMA (see CTFG, Key Documents). These results/figures will be updated two times a year.
The Paul-Ehrlich-Institut coordinates the procedures and provides the newest results/figures here: