The Current Climate of Clinical Trials in Russia and Ukraine | Page 9

Fees
The fees include a permit fee that is paid to the MoH
according to the Tax Code (Note: an invoice is not
issued by the MoH for the payment), payment either
to the hospital/institution or directly to the
investigators and the mandatory insurance for all
clinical trial participants.

Import of Medications and Materials
Approval is required to import medications for the
purpose of clinical trials. Approval can be gained
by submitting an application for a license to import
medications to the MoH. CROs are authorized legal
entities that can obtain this approval,28 which usually
takes no more than two weeks from submission.

Because the contract with hospitals should be signed
in rubles only (cannot be USD or EUR), it can be
problematic to pay hospitals from abroad; only a
Russian company can pay another Russian company
in rubles. When paying the investigators directly,
obligatory payments include the pension fund (22%)
and the fund for obligatory health insurance (5.1%).
For these reasons, it can be beneficial to work with a
locally based contract research organization (CRO).

When shipping medications to Russia for the purposes
of clinical trials, which does not require certification, it
usually takes five to seven days fro