Article 9. State Control over Circulation of Medicines

1. All medicines manufactured in the Russian Federation and imported into the Russian Federation are subject to state control.

2. State control over circulation of medicines shall be carried out by the authorized federal executive bodies and executive bodies of the constituent entities of the Russian Federation in compliance with the powers thereof.

3. State control over circulation of medicines includes control over preclinical testing of medicines, clinical trials of medicinal products, quality, manufacturing of medicines, compounding of medicinal products, storage, transportation, import to the territory of the Russian Federation, advertisement, dispensation, distribution, and destruction of medicines and use of medicinal products.

4. State control over circulation of medicines is carried out by means of:

1) inspections of the subjects of circulation of medicines for compliance with the good laboratory practices, good clinical practices with respect to preclinical testing of medicines and clinical trials of medicinal products for and preclinical testing of medicines and clinical trials of medicinal products for veterinary use, good manufacturing practices, regulations for wholesale of medicines, regulations for dispensation of medicinal products, regulations for compounding and dispensation of medicinal products, regulations for storage of medicines and rules for destruction of medicines;

2) licensing of manufacturing of medicines and pharmaceutical activities; inspections for compliance with the license requirements and provisions;

3) quality control of medicines in civil circulation:

a) in the form of sampling control;
b) in case of incompliance of manufacturing and quality control over medicines, wholesale of medicines, retail of medicinal products, manufacturing practices for medicinal products and storage regulations for medicines with the license requirements and provisions;

4) issuance of permits to import medicines into the Russian Federation;

5) safety monitoring of medicinal products;

6) obtaining information related to determination and use of prices and mark-ups to the prices from executive bodies of the constituent entities of the Russian Federation and from the subjects of circulation of medicines for medical use at the requests of the authorized federal executive body.

5. State control in the process of circulation of medicines is an expenditure commitment of the Russian Federation or of the constituent entities of the Russian Federation depending on the type of control, which can be assigned either to the powers of the federal executive bodies or to the powers of the executive bodies of the constituent entities 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)