State Institute for Drug Control notifies to Applicants for Clinical Trials that will not participate in the assessment of applications under the Voluntary Harmonisation Procedure (VHP) till 31st December 2013. Such request for Clinical Trial may be submitted in parallel wayby national submission. This Communication does not address Substantial Amendments to the studies that have been previously approved under the VHP procedure, which should continue to be submitted via VHP procedure.
Any change to this information will be notified.
Clinical Trial Unit
15th October 2013