Chapter 10. Pharmaceutical Activity

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 52. Realization of Pharmaceutical Activity

1. Pharmaceutical activity is carried out by wholesalers of medicines, pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity, medical organizations having a license for pharmaceutical activity and their separate subdivisions (ambulance stations, paramedic’s and paramedical-obstetric centers, centers (departments) of general (family) practice) located in rural settlements which have no pharmacy offices, and veterinary organizations licensed to carry out pharmaceutical activity.

2. Individuals may be engaged in certain pharmaceutical activities provided that they have higher or secondary pharmaceutical education, higher or secondary veterinary education and a certificate of a specialist.

Article 53. Sale, Transfer of Medicines by Wholesalers of Medicines

Wholesalers of medicines may sell medicines or transfer the latter in the manner established by the legislation of the Russian Federation to:

1) other wholesalers of medicines;
2) manufacturers of medicines for manufacturing purposes;
3) pharmacy institutions and veterinary pharmacy organizations;
4) scientific-and-research centres for research activities;
5) individual entrepreneurs licensed to carry out pharmaceutical activity or having a license to carry out medical activities;
6) medical organizations, veterinary institutions;
7) institutions that deal with the animals breeding, rearing and keeping.

Article 54. Regulations for Medicines Wholesale

Manufacturers and wholesalers of medicines shall perform wholesaling of medicines subject to the regulations approved by the relevant authorized federal executive bodies.

Article 55. Procedure for Medicinal Products Retail

1. Retailing of the medicinal products in such quantities as necessary to fulfill physician’s (physician assistant’s) prescriptions or the prescription of a veterinarian is carried out by pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity, medical organizations having a license for pharmaceutical activity and their separate subdivisions (ambulance stations, paramedic’s and paramedical-obstetric centers, centres (departments) of general (family) practice) located in rural settlements which have no pharmacy offices, and veterinary organizations licensed to carry out pharmaceutical activity. Only medicinal products registered in the Russian Federation or compounded by pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity are allowed to be retailed.

2. The types of pharmacy institutions and the rules of dispensation of medicinal products for medical use through pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity, as well as the rules of dispensation of medicinal products for through medical organizations having a license for pharmaceutical activity and their separate subdivisions (ambulance stations, paramedic’s and paramedical-obstetric centers,, centres (departments) of general (family) practice) located in rural settlements which have no pharmacy offices shall be approved by the authorized federal executive body.

3. The rules of dispensation of narcotic drugs and psychotropic substances registered as medicinal products, and of medicinal products containing narcotic drugs and psychotropic substances shall be approved by the authorized federal executive body by agreement with the federal executive authorities carrying out functions of the state policy development, normative and legal regulation, control and supervision in the area of narcotic drugs, psychotropic substances and their precursors circulation, as well as in the area of counteracting their illicit circulation.

4. Medicinal products for veterinary use are subject to be dispensed through veterinary pharmacy institutions, veterinary organizations and individual entrepreneurs licensed to carry out pharmaceutical activity. The rules of dispensation of medicinal products for veterinary use shall be approved by the authorized federal executive body.

5. The list of medical organizations having a license for pharmaceutical activity and their separate subdivisions (ambulance stations, paramedic’s and paramedical-obstetric centers, centers (departments) of general (family) practice) located in rural settlements which have no pharmacy offices, as well as the list of medicinal products (except for narcotic medicinal products and psychotropic medicinal products), which can be sold by the organizations mentioned above and by their separate subdivisions shall be specified by executive authorities of the Russian Federation constituent entities.

6. Pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity are obliged to provide a minimum range of medicinal products necessary to deliver health care, as established by the authorized federal executive body.

7. In addition to medicinal products, pharmacy institutions, individual entrepreneurs licensed for a pharmaceutical activity are entitled to acquire and sell medical accessories, disinfectants, personal hygiene means and items, vessels for health care purposes, means and items designed for taking care of patients, newborns and children under three years of age, eyewear and means of taking care thereof, mineral water, health food, baby food and invalid food, biologically active additives to food, medical cosmetics and perfume products, medical and sanitary educative printed publications for healthy lifestyle promotion.

8. The activities of pharmacy institutions in the Armed Forces of the Russian Federation, other corps and military units and bodies, wherein military and law enforcement service is provided for by the legislation, are regulated by the present Federal Law and the regulations approved by the competent federal executive bodies. The control over the said pharmacy institutions being in compliance with the provisions hereof is exercised by the appropriate federal executive bodies.

Article 56. Compounding and Dispensation of Medicinal Products

1. Compounding of medicinal products by pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity shall be performed based on the medicinal products prescriptions, requirements of medical organizations and veterinary institutions according to the rules for compounding and dispensation of medicinal products, as approved by the authorized federal executive body.

2. When they compound medicinal products, pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed to carry out pharmaceutical activity shall use the pharmaceutical substances included into the state register of medicines for and the state register of medicines for veterinary use respectively in the appropriate way. The pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs with a pharmaceutical license are not allowed to compound the medicinal products registered in the Russian Federation.

3. Marking and labeling of medicinal products compounded by a pharmacy institution, a veterinary pharmacy institution and an individual entrepreneur with a pharmaceutical license shall be consistent with the rules specified in Clause 1 of this Article.

4. A pharmacy institution, a veterinary pharmacy institution and an individual entrepreneur with a pharmaceutical license shall bear responsibility for failure to comply with the rules for compounding and dispensation of medicinal products in accordance with the legislation of the Russian Federation.

Article 57. Ban on Sale of Counterfeit Medicines, Poor Quality Medicines or Infringing Medicines

It is forbidden to sell counterfeit medicines, poor quality medicines, and infringing 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)