ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 8, 2025 No. 462

About state regulation of the prices of the medicines included in the list of vital and essential drugs for medical application

According to Articles 61 - 63 Federal Laws "About Drug Circulation" Government of the Russian Federation decide:

1. Approve enclosed:

Rules of state registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application;

Rules of maintaining the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application;

Rules of establishment by executive bodies of subjects of the limiting Russian Federation of the sizes of wholesale allowances and the extreme sizes of retail allowances to the actual selling prices established by producers of medicines on the medicines included in the list of vital and essential drugs for medical application;

Rules of forming of selling prices on the medicines included in the list of vital and essential drugs for medical application, the organizations of wholesale trade by medicines, the pharmaceutical organizations, the individual entrepreneurs having the license for pharmaceutical activities, the medical organizations having the license for pharmaceutical activities and their separate divisions located in rural settlements in which there are no pharmaceutical organizations;

changes which are made to acts of the Government of the Russian Federation.

2. To give to the Ministry of Health of the Russian Federation and Federal Antimonopoly Service in need of explanation on application of the rules approved by this resolution.

3. Recognize invalid acts and separate provisions of acts of the Government of the Russian Federation according to the list according to appendix.

4. This resolution becomes effective since September 1, 2025 and is effective till September 1, 2031.

Approved by the Order of the Government of the Russian Federation of April 8, 2025 No. 462

 Rules of state registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application

1. These rules establish procedure of marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application approved by the Government of the Russian Federation (further respectively - medicines, marginal selling prices, state registration), and re-registrations of the registered marginal selling prices (further - re-registration).

2. Rendering the state service in state registration and re-registration is free.

3. State registration and re-registration, and also entering of the registered or re-registered marginal selling price into the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application (further - the marginal register of selling prices), is performed by the Ministry of Health of the Russian Federation.

4. The bases for refusal by the Ministry of Health of the Russian Federation in state registration or re-registration are:

a) excess declared for state registration or marginal re-registration of selling price over the marginal selling price determined taking into account requirements of Items 12 and 13 of these rules;

b) non-presentation of the additional information, stipulated in Item 16 these rules;

c) the decision of Federal Antimonopoly Service on refusal in marginal coordination of selling price based on which the Ministry of Health of the Russian Federation makes the decision on refusal in state registration or re-registration.

5. The marginal economic analysis of selling price (further - the economic analysis) in case of its state registration and re-registration is performed by Federal Antimonopoly Service.

6. For state registration and marginal re-registration of selling price the holder or the owner of the registration certificate of medicine or person authorized by it (further - the applicant) submits in the Ministry of Health of the Russian Federation the application for marginal state registration of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application in form according to appendix No. 1 (further - the statement for state registration) or the statement for marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs for medical application in form according to appendix No. 2 (further - the statement for re-registration) by means of the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal) or in private office of the Ministry of Health of the Russian Federation in single state information system in health sector (further - unified information system) in the form of the electronic documents signed by the digital signature of the applicant which types are provided by the Federal Law "About Drug Circulation".

7. For the purposes of state registration the applicant represents documents and data, in electronic form by means of the single portal or the unified information system, taking into account requirements of marginal method of calculation of selling prices of producers of the medicines included in the list of vital and essential drugs for medical application approved according to the Federal Law "About Drug Circulation" (further - technique), including:

a) data on amounts and on the prices of leave of the medicine of the producer of state member of the Eurasian Economic Union and medicine of foreign production which is in circulation in the territory of the Russian Federation which primary and (or) secondary package is performed or primary and (or) secondary package of which are planned to be performed in the Russian Federation, the confirmations further undergoing the procedure by means of monitoring system of movement of medicines for medical application (further - monitoring system);

b) marginal calculation of the selling price represented on state registration;

c) marginal calculation of the selling price on the reproduced, bioanalog (biosimilar) medicine represented on state registration;

d) marginal calculation of selling price on medicine of the producer of the state member of the Eurasian Economic Union represented on state registration;

e) data on availability of the registered marginal selling prices on the declared medicine.

8. For the purposes of re-registration the applicant represents the documents and data, in electronic form by means of the single portal or unified information system, taking into account requirements of technique including:

a) data on amounts and on the prices of leave of the medicine of the producer of state member of the Eurasian Economic Union and medicine of foreign production which is in circulation in the territory of the Russian Federation which primary and (or) secondary package is performed or primary and (or) secondary package of which are planned to be performed in the Russian Federation, the confirmations further undergoing the procedure by means of monitoring system;

b) marginal calculation of the selling price represented on re-registration;

c) marginal calculation of selling price on medicine of the producer of the state member of the Eurasian Economic Union represented on re-registration;

d) data on availability of the registered marginal selling prices on the declared medicine;

e) reasons for marginal calculation of selling price on medicine of the producer of the state member of the Eurasian Economic Union represented on re-registration;

e) reasons for marginal calculation of selling price on medicine of foreign production, including primary and (or) secondary package of which are performed or primary and (or) secondary package of which are planned to perform in the Russian Federation represented on re-registration.

9. If the applicant is acted by the other person on behalf, its powers shall be confirmed in the procedure established by the legislation of the Russian Federation. For confirmation of powers of the representative of the applicant use including the machine-readable power of attorney created with use of the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically" is allowed.

The representative of the applicant has the right to submit on own initiative other documents confirming him powers.

10. The applicant of the documents and data provided by Items 6 having the right in addition to the list - 8 these rules to submit on own initiative other documents and data for state registration and re-registration.

11. The data containing in the statement for state registration and the statement for re-registration shall correspond to the data specified in the registration certificate of medicine issued in accordance with the legislation of the Russian Federation and (or) in the registration certificate issued according to the Rules of registration and examination of medicines for medical application approved by the decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 "About Rules of registration and examination of medicines for medical application" on the date of submission of the corresponding statement.

12. In case of submission by the applicant of the statement for state registration before the expiration of 3 years from the date of acceptance by the Ministry of Health of the Russian Federation decisions on marginal exception of selling price of the marginal register of selling prices the declared marginal selling price cannot exceed earlier excluded marginal selling price (without the production site) proceeding from the cost of one dosage form of the corresponding dosage of medicine.

13. The selling price declared to marginal state registration cannot exceed the price specified in subitem 5.5.4 of appendix No. 1 to the Rules of forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care approved by the order of the Government of the Russian Federation of August 28, 2014 No. 871 "About approval of Rules of forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care".

14. The Ministry of Health of the Russian Federation within 10 working days from the date of adoption of the documents and data provided by Items 6 - 10, 24, 25 and 37 these rules:

a) performs completeness and reliability of the data containing in the submitted documents including with use of the state register of medicines and monitoring systems, and by means of unified information system sends to Federal Antimonopoly Service the specified documents and data for carrying out the economic analysis;

b) requests if necessary from the Ministry of Industry and Trade of the Russian Federation according to the procedure of interdepartmental information exchange by means of single system of interdepartmental electronic interaction of the data on the license for production of medicines concerning each medicine specified in the statement for state registration or the statement for re-registration;

c) receives from monitoring system of the data on amounts and about the prices of import of medicine of the foreign production which is in circulation in the territory of the Russian Federation;

d) creates and sends to the applicant by means of the single portal and unified information system the letter signed by the strengthened qualified digital signature on the direction of the documents and data provided by Items 6 - 8 these rules, to Federal Antimonopoly Service;

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