Article 63. Determination by Executive Authorities of the Russian Federation Constituent Entities of Maximum Wholesale and Maximum Retail Mark-Ups to Actual Ex-Works Prices of Manufacturers of Medicinal Products for Medicinal Products for Medical Use

1. The executive authorities of the Russian Federation constituent entities determine maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products in accordance with the methodology of determination by the executive authorities of the Russian Federation constituent entities of maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products, which methodology shall be approved in the order prescribed by the Government of the Russian Federation.

2. The wholesalers and (or) pharmacy institutions, individual entrepreneurs licensed for pharmaceutical activity shall sell the medicinal products included into the list of vital and essential medicinal products at the prices, the level of which shall not exceed the amount of the actual ex-works price specified by the manufacturer of medicinal products and not higher than the registered maximum ex-works price, and wholesale and (or) retail mark-ups shall not exceed maximum wholesale and maximum retail mark-ups respectively determined by the Russian Federation constituent entity.

3. The executive bodies of the Russian Federation constituent entities shall place on the official web-site or publish the information on the registered maximum ex-works price for the medicinal products included into the list of vital and essential medicinal products, on the set in the Russian Federation constituent entity maximum wholesale mark-up and (or) maximum retail mark-up to the actual ex-works prices of the manufacturers of medicinal products for the medicinal products included into the list of vital and essential medicinal products, and on the amount mention in Clause 2 of this Article. The information provided for in this Clause shall also be placed in pharmacy institutions in the form available for all parties concerned and it shall be updated as being published.

4. The decisions of the executive authorities of the Russian Federation constituent entity on determination of maximum wholesale and maximum retail mark-ups to the registered maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products, which decisions were taken in violation of the legislation of the Russian Federation, are subject to be revoked judicially.,

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)