Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in 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)

Article 64. Safety Monitoring of Medicinal Products

1. The medicinal products being in circulation in the Russian Federation shall be subject to the safety monitoring in order to reveal possible negative consequences of their use, to prevent and protect patients against the use of such medicinal products.

2. The safety monitoring of medicinal products at all stages of their circulation in the Russian Federation shall be performed by the authorized federal executive body.

3. Subjects of medicines circulation shall, in the order established by the authorized federal executive body, inform of any and all cases of side effects inconsistent with the information contained in the Package Leaflet for  medicinal products, of serious adverse reactions and unexpected adverse reactions that have occurred when administering the medicinal products, and of particularities of interaction of the medicinal products with other medicinal products that were registered when conducting clinical trials, as well as when administering the medicinal products.

4. Failure to inform on or non-disclosure of the data contemplated in Clause 3 of this Article by individuals to whose notice such information came by the nature of their professional occupation, shall be liable in accordance with the legislation of the Russian Federation.

5. The procedure for conduction of safety monitoring of medicinal products, registration of side effects, serious adverse reactions and unexpected adverse reactions that have occurred when administering medicinal products, including for presentation of information thereof, is to be established by the authorized federal executive body.

Article 65. Suspension of Medicinal Product

When obtaining information on cases of side effects, which are not specified in the Package Leaflet for a medicinal product, serious adverse reactions and unexpected adverse reactions that have occurred when administering medicinal products, on particularities of its interaction with other medicinal products, which may constitute a threat to the life or health of patients, as well as information inconsistent with the information on the medicinal product contained in the Package Leaflet, the authorized federal executive body shall consider the question of possible suspension of that medicinal product in the order established by the authorized federal executive body.

Article 66. Information on the Results of Safety Monitoring of Medicinal Products

The authorized federal executive body carrying out the safety monitoring of the medicinal products being in circulation in the Russian Federation shall, subject to the monitoring results, place on the official web-site the information on decisions taken as to making amendments to the Package Leaflet for a medicinal product, suspending of the medicinal product, withdrawal of the medicinal product from circulation, or recommencement of the medicinal product.

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)