Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use

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 60. State Regulation of Prices for Medicinal Products for Medical Use

The state regulation of prices for medicinal products for medical use shall be exercised as follows:

1) approval of the list of vital and essential medicinal products that are included into such list under international nonproprietary or chemical names and which meet the following criteria:

a) administration of the particular medicinal product for diagnostics, prevention and treatment of diseases including those prevailing in the morbidity structure of the Russian Federation;
b) the advantage of the specific medicinal product compared to other medicinal products for a particular disease, syndrome or clinical case;
c) therapeutic equivalence of the specific medicinal product to medicinal products having the similar mechanism of pharmacologic action;

2) approval of the methodology for determination of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

3) state registration of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

4) maintaining 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;

5) approval of the methodology for determination by 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;

6) determination 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;

7) approval of the procedure for giving mandatory instructions to the executive authorities of the Russian Federation constituent entities to bring their decisions on determination 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 into compliance with the legislation of the Russian Federation in the order established by the Government of the Russian Federation, if such decisions were taken in violation of the legislation of the Russian Federation;

8) addressing executive authorities of the Russian Federation constituent entities by an authorized federal executive body with mandatory instructions to bring the decisions on determination of maximum wholesale and maximum retail mark-ups to the actual ex-works prices for the medicinal products included in the list of vital and essential medicinal products taken in violation of the laws of the Russian Federation into compliance with the legislation of the Russian Federation;

9) exercise of state control over application of the prices for medicinal products in the order prescribed by the Government of the Russian Federation; (as amended by Federal Law of October 11, 2010, No. 271-FZ)

10) application of sanctions for violation of the pricing procedure for the vital and essential medicinal products as provided for by the legislation of the Russian Federation.

Article 61. State Registration of Manufacturers’ Maximum Ex-Works Prices for Vital and Essential Medicinal Products and Their Sale

1. The determined by the manufacturers of the medicinal products maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products shall be subject to state registration.

2. The maximum ex-works price for vital and essential medicinal products proposed by a manufacturer is subject to state registration, unless it exceeds the price for the same medicinal product calculated in accordance with the methodology for determination of the manufacturers’ maximum ex-works prices for vital and essential medicinal products, which shall be approved in the order prescribed by the Government of the Russian Federation. This method assumes the calculation of weight-average actual ex-works price, weight-average actual import price of the medicinal product during the year, preceding the date of presenting of manufacturer's maximum ex-works price to state registration, for medicinal products being in circulation in the Russian Federation, and the calculation by the Russian manufacturers of medicinal products of costs associated to developing, manufacturing, sales, specifying by foreign manufacturers of medicinal products of minimal manufacturer's ex-works price for the medicinal product in manufacturer's country and other countries, where it is registered, with taking into account the costs associated to customs clearance (customs duty and customs fees for the customs clearance) and transport charges for medicinal products which did not come in circulation in the Russian Federation and originator medicines. (as amended by Federal Law of October 11, 2010, No. 271-FZ)

2¹. In calculation of maximum ex-works price the following shall be taken into account along to the data specified in Clause 2 of this Article:

1) regarding to Russian manufacturer – the price on analogous (by international non-proprietary name, certain dosage form and dosage rate) medicinal products, manufactured in the Russian Federation or in case of absence of such - the price on analogous foreign medicinal products being in civil circulation in the Russian Federation;
2) regarding to foreign manufacturer -  the price on analogous (by international non-proprietary name, certain dosage form and dosage rate) medicinal products being in civil circulation in the Russian Federation”; (clause 2¹ introduced by Federal Law of October 11, 2010, No. 271-FZ)

2². On the ground of the statement submitted up to October 1 of each year by the Russian manufacturer of medicinal products, included in the list of vital and the most important medicinal products, registered maximum ex-works price for the medicinal product in case of change of prices for raw materials, indirect costs, as well as estimated inflation on the base of the federal budget for the respective financial period and scheduled period, may be re-registered, but not more than ones per calendar year  in the order established by the Clauses 2 and 2¹ of this Article. (clause 2² introduced by Federal Law of October 11, 2010, No. 271-FZ)

3. It is prohibited to sell medicinal products included in the list of vital and essential medicinal products, the manufacturer’s maximum ex-works price for which have not been registered.

Article 62. State Register of Manufacturers’ Maximum Ex-Works Prices for Medicinal Products Included into the List of Vital and Essential Medicinal Products

1. The registered maximum ex-works prices for the medicinal products included into the list of vital and essential medicinal products are subject to inclusion into the state register of manufacturers’ maximum ex-works prices for the medicinal products included into the list of vital and essential medicinal products.

2. The state register of manufacturers’ maximum ex-works prices for the medicinal products included into the list of vital and essential medicinal products shall contain the following information:

1) name of the manufacturer of the medicinal product;
2) name of the medicinal product (international nonproprietary or chemical and trade names);
3) number of registration certificate for the medicinal product;
4) dosage form with indication of the dosage rate of the medicinal product and its quantity in the secondary (consumer) package;
5) registered maximum ex-works price in rubles;
6) registration date of the maximum ex-works price for the medicinal products included into the list of vital and essential medicinal products.

3. The state registration of the maximum ex-works prices for the medicinal products included into the list of vital and essential medicinal products, as well as the maintenance of the state register of the manufacturers’ maximum ex-works prices for the medicinal products included into the list of vital and essential medicinal products shall be exercised in the order prescribed by the Government of the Russian Federation.

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)