Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines

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 5. Powers of Federal Executive Bodies with Respect to Circulation of Medicines

Powers of federal executive bodies with respect to circulation of medicines include:

1) pursuing of a unified state policy in the area of supply of the citizens with medicinal products in the Russian Federation;

2) approval of general pharmacopeia monographs and pharmacopeia monographs and enactment of the state pharmacopeia;

3) provision of state control and supervision;

4) licensing of manufacturing of medicines and pharmaceutical activities in compliance with the legislation of the Russian Federation;

5) arrangement of medicines expert examination and ethical expert examination of the possibility to conduct a clinical trial of a medicinal product for medical use;

6) issue of permits for conducting clinical trials of medicinal products; maintenance of the register of issued permits for the conduct of clinical trials of medicinal products;

7) state registration of medicinal products; maintenance of the state register of medicines;

8) inspection of manufacturing of medicines for compliance with the good manufacturing practices; issue of conclusions on compliance of medicines manufacturers with the requirements of the good manufacturing practices;

9) state registration of maximum ex-works prices for the vital and essential medicinal products determined by the manufacturers of the medicinal products and maintenance of the state register of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

10) establishment of the procedure for import of medicines into the Russian Federation and export of medicines from the Russian Federation;

11) foundation of councils responsible for issues related to circulation of medicines;

12) evaluation and certification of specialists;

13) approval of professional training programs;

14) safety monitoring of medicinal products;

15) participation in international cooperation;

16) obtaining information related to determination and use of prices for medicinal products and mark-ups to the prices from executive bodies of the constituent entities of the Russian Federation, as well as from the subjects of circulation of medicines for medical use, at the requests of the authorized federal executive body;

17) imposing of sanctions for violation of the legislation of the Russian Federation;

Article 6. Powers of Executive Bodies of Subject of Russian Federation with Respect to Circulation of Medicines

Powers of the executive bodies of a constituent entity of the Russian Federation with respect to circulation of medicines include:

1) development and implementation of regional programs for supply of medicinal products to the population;

2) determination of maximum wholesale mark-ups and maximum retail mark-ups to the actual ex-works prices determined by the manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products;

3) verification of prices for the medicinal products included in the list of vital and essential medicinal products by wholesalers, pharmacy institutions and individual entrepreneurs holding pharmaceutical licenses.

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)