Article 69. Compensation for Harm to Human Health Caused by Administration of Medicinal Products

1. The manufacturer of the medicinal product shall be obliged to compensate for the harm to human health caused by the administration of the medicinal product provided it is proved that:

1) the medicinal product was used for its intended purpose in accordance with the Package Leaflet for a medicinal product and the harmful action of the medicinal product was due to introduction to the civil circulation of a poor quality medicinal product;
2) the damage to health was caused by administration of the medicinal product through misleading Package Leaflet for a medicinal product issued by the manufacturer of the medicinal product.

2. If the damage to health was caused by administration of a medicinal product that became a substandard medicinal product due to a breach of storage procedure for medicines, the regulations for wholesaling of medicines, the rules for dispensation of medicinal products, the rules for manufacture and dispensation of medicinal products, then the compensation shall be provided by the medicines wholesaler, pharmacy institution, individual entrepreneurs having a pharmaceutical license or a medical license, by health care organization (its separate subdivision (ambulance stations, paramedic’s and paramedical-obstetric centers, centres (departments) of general (family) practice) located in rural settlements which have no pharmacy offices) responsible for releasing the medicinal product for distribution, or for the dispensation thereof.

3. Compensation for harm to human health caused by administration of medicinal products or illegal actions by subjects of medicines circulation is provided in accordance with the Legislation of the Russian Federation.

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)