Voluntary Harmonization Procedure (VHP)

Christmas break for VHP procedures

SÚKL informs about a Christmas break for VHP procedures (Clinical Trial Applications submitted via VHP procedure). This break does not aplly to national submissions of Clinical Trial Applications.  

 

Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure on the Possibility of Involvement of Multicentric Ethics Committees, So Called VHP Plus (HMA CTFG website refers)

The State Institute for Drug Control hereby informs the sponsors of clinical trials  that as part of the VHP Plus project, starting from February 2018 in the Czech Republic, multicentric ethics committees may also be involved in the assessment of clinical trial applications under the Voluntary Harmonisation Procedure (VHP). The joint assessment process will be coordinated and safeguarded by coordinators of Czech competent authority the State Institute for Drug Control.  

 

Important information for Applicants for Clinical Trials via VHP procedure

State Institute for Drug Control informs applicants for Clinical Trials, that it participates in all assessment of applications under Voluntary Harmonisation Procedure (VHP).