Regulatory and legal aspects of the off-label use of medicines in the Russian Federation

Baryshnikovа I.N.: Department of Outpatient Therapy and Clinical Pharmacology

Ketova G.G.: Department of Outpatient Therapy and Clinical Pharmacology

Zaripova G.R.: Department of Clinical Pharmacology and Therapy

Shamurova U.U.: Department of Outpatient Therapy and Clinical Pharmacology

Kuzin A.I.: Department of Clinical Pharmacology and Therapy

Shamina O.M.: Department of Outpatient Therapy and Clinical Pharmacology

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Summary

The authors discuss the main regulatory and legal aspects of the off-label use of medicines in the Russian Federation and possible procedural consequences for the attending physician and medical organization in case of harm to the health and/or life of the patient. The Russian Federation legislation regulating the off-label drugs administration requires clarification and revision. Potential ways to solve the existing issues are proposed.

Key words

Off-label drugs, off-label use, causing harm to the health and/or life of the patient.