|
RUSSIAN FEDERATION
Federal Law On Circulation of Medicines 61-FZ
Adopted by Approved by
the State Duma the Council of Federation
March 24, 2010 March 31, 2010
(as amended by Federal Laws of October 11, 2010, No. 271-FZ, of November 29, No. 313-FZ)
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 1. Subject of Regulation of This Federal Law
1. This Federal Law regulates relations arising in connection with circulation, i.e. development, preclinical testing, clinical trials, expert examination, evaluation, state registration, standardization and quality control, manufacture, compounding, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensation, distribution, transfer, use and destruction of medicines.
2. This Federal Law establishes the priority of the state control of safety, quality and efficacy of medicines in the process of their circulation.
Article 2. Scope of Application of this Federal Law
This Federal Law applies to relations arising in the process of circulation of medicines in the Russian Federation.
Article 3. Legislation on Circulation of Medicines
1. Legislation on circulation of medicines comprises this Federal Law, other federal laws and other regulatory legal acts of the Russian Federation.
2. This Federal Law applies to circulation of narcotic and psychotropic medicines with account of the specifics established by the legislation of the Russian Federation on narcotic drugs, psychotropic substances and precursors thereof.
3. This Federal Law applies to circulation of radiopharmaceutical medicines with account of the specifics established by the legislation of the Russian Federation in the area of radiation safety.
4. If an international treaty of the Russian Federation establishes rules other than those stipulated by this Federal Law, the rules of the international treaty shall apply.
5. In the Russian Federation in accordance with the international treaties of the Russian Federation and (or) based on the principle of reciprocity, results of clinical trials of medicinal products for medical use conducted outside the Russian Federation shall be acknowledged.
Article 4. Basic Terms Used in this Federal Law
For the purpose of this Federal Law the following basic concepts are used:
1. Medicines;
2. Pharmaceutical substances;
3. Excipients;
4. Medicinal products;
5. Dosage form;
6. List of vital and essential medicinal products;
7. Immunobiological medicinal products;
8. Narcotic medicines;
9. Psychotropic medicines;
10. Radiopharmaceutical medicines;
11. Originator medicine;
12. Generic medicine;
13. Herbal medicinal raw material;
14. Herbal medicinal product;
15. Homeopathic medicine;
16. International nonproprietary name of a medicine;
17. Trade name of a medicine;
18. General pharmacopoeia monograph;
19. Pharmacopoeia monograph;
20. Normative documentation;
21. Normative document;
22. Quality of a medicine;
23. Safety of a medicine;
24. Efficacy of a medicinal product;
25. Batch of a medicine;
26. Registration certificate of a medicinal product;
27. Registration number;
28. Сirculation of medicines;
29. Subjects of circulation of medicines;
30. Developer of a medicine;
31. Manufacturing of medicines;
32. Manufacturer of medicines;
33. Pharmaceutical activities;
34. Wholesaler of medicines;
35. Pharmacy institution;
36. Veterinary pharmacy institution;
37. Infiringing medicine;
38. Poor quality medicine;
39. Сounterfeited medicine;
40. Preclinical testing of a medicine;
41. Clinical trials of a medicinal product;
42. Multicentre clinical trial of a medicinal product for medical use;
43. International multicentre clinical trial of a medicinal product for medical use;
44. Post-registration clinical trial of a medicinal product for medical use;
45. Bioequivalence study of a medicinal product;
46. Therapeutic equivalence study of medicinal products;
47. Protocol of a clinical trial of a medicinal product;
48. Investigator's brochure;
49. Patient information sheet;
50. Side effect;
51. Serious adverse reaction;
52. Unexpected adverse reaction;
53. Medicinal product prescription;
54. Medical institution or veterinary institution order.
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)
|
