ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 18, 2017 No. 1115

About approval of Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product

According to article 17 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

Approve the enclosed Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product.

Approved by the Order of the Government of the Russian Federation of September 18, 2017 No. 1115

Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product

1. These Standard rules establish conditions and procedure for the conclusion of the agreement of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product (further - clinical trial), determine including procedure for establishment of the size of insurance rates by compulsory insurance of life and health of the patient, 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 in case of damnification of his life or to health as a result of performing clinical trials, the standard rates reflecting nature and extent of damnification to health and extend to the relations, arising from the specified agreement.

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

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