ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 13, 2010 No. 714

About approval of Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine

According to article 44 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

Approve the enclosed Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine.

Approved by the Order of the Government of the Russian Federation of September 13, 2010 No. 714

Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine

I. General provisions

1. These Standard rules establish insurance rates on compulsory insurance of life and health of the patient participating in clinical trials of medicine for medical application (further - clinical trials), procedure for establishment by the insurer of individual identification code of the patient, procedure for informing the insurer by the insurer on the patients involved in clinical trial, payment procedure of insurance premium, the list of necessary documents for implementation of insurance payment, procedure for realization of the rights and obligations of the Parties under the agreement of compulsory insurance of life and health of the patient participating in clinical trials in case of damnification of his life or to health as a result of performing clinical trials and extend to the relations arising from the specified agreement.

2. In these Standard rules the following basic concepts are used:

"patient" - the physical person which was this the voluntary informed consent on the participation in the clinical trials conducted by the medical organization confirmed with its signature or the signature of his legal representative on the information leaflet of the patient;

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