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

The government of the Russian Federation decides:

1. Approve the enclosed Rules of forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care.

2. To the Ministry of Health of the Russian Federation to approve regulations on the commission of the Ministry of Health of the Russian Federation on forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care, and structure of said commission.

3. Determine that in 2014 offers on forming of lists of medicines for medical application and the minimum range of the medicines necessary for delivery of health care, go to the Ministry of Health of the Russian Federation according to the procedure, provided by the Rules approved by this resolution till September 15, 2014.

4. Item 4 of the order of the Government of the Russian Federation of October 29, 2010 No. 865 "About state regulation of the prices of the medicines included in the list of vital and essential drugs" (The Russian Federation Code, 2010, No. 45, Art. 5851; No. 37, the Art. 5002) after words "Ministry of Economic Development of the Russian Federation" to add 2012, with words ", the Ministry of Labour and Social Protection of the Russian Federation, the Ministry of Regional Development of the Russian Federation, Federal Antimonopoly Service, Federal Service for the Oversight of Consumer Protection and Welfare, the Federal Agency for Scientific Organizations".

5. To make to the Ministry of Health of the Russian Federation explanations about procedure for application of the Rules approved by this resolution.

Approved by the Order of the Government of the Russian Federation of August 28, 2014 No. 871

Rules of forming of lists of medicines for medical application and minimum range of the medicines necessary for delivery of health care

1. These rules establish procedure for forming:

a) the list of vital and essential drugs for medical application (further - the list of the major medicines);

b) the list of the medicines intended for providing persons sick with hemophilia, mukovistsidozy, by hypophysial nanizm, disease to Gosha, malignant new growths lymphoid, haematogenic and related it fabrics, multiple sclerosis, gemolitiko-uraemic syndrome, juvenile arthritis with the system beginning, mukopolisakharidozy I, II and VI types, the aplastic anemia which is not specified, heritable deficit of factors of II (fibrinogen), the VII (labile), X (Stewart - Prauera), and also persons after organ transplantation and (or) fabrics (further - the list of expensive medicines);

c) ceased to be valid

d) the minimum range of the medicines necessary for delivery of health care (further - the minimum assortment).

2. The list of the major medicines is created of medicines for medical application (further - medicines) according to international non-proprietary names of these medicines (in the absence of such names - according to grouping or chemical names), including taking into account standards of medical care, results of clinical approbation of methods of prevention, diagnostics, treatment and rehabilitation and clinical recommendations, with indication of method and (or) way of introduction of medicine, and also basic element or additional element of dosage forms, including like release of active ingredient (in the presence), answering to at the same time following criteria:

a) medicine is registered in accordance with the established procedure in the Russian Federation;

b) medicine is applied for the purpose of diagnostics, prevention, treatment and rehabilitation in case of delivery of health care in case of the diseases and conditions including prevailing in structure of incidence in the Russian Federation, and also diseases constituting danger to people around;

c) medicine has the proved clinical, and (or) kliniko-economic benefits, and (or) features of the mechanism of action, and (or) bigger safety in case of diagnostics, prevention, treatment or rehabilitation of diseases, syndromes and conditions in comparison with other medicines in case of treatment of certain disease or condition.

3. The list of expensive medicines is created according to international non-proprietary names of these medicines (in the absence of such names - according to grouping or chemical names) within amounts of the budgetary appropriations provided in the federal budget for the corresponding financial year and planning period from the medicines answering to the following criteria:

a) medicine is registered in accordance with the established procedure in the Russian Federation;

b) medicine is included into the list of the major medicines;

c) medicine has advantage in comparison with other medicines in case of treatment of persons sick with hemophilia, mukovistsidozy, hypophysial nanizm, disease to Gosha, malignant new growths lymphoid, haematogenic and related it fabrics, multiple sclerosis, gemolitiko-uraemic syndrome, juvenile arthritis with the system beginning, mukopolisakharidozy I, II and VI types, the aplastic anemia which is not specified, heritable deficit of factors of II (fibrinogen), the VII (labile), X (Stewart - Prauera), and also persons after organ transplantation and (or) fabrics.

3(1). Inclusion of medicine in the list of expensive medicines and if necessary exception of it according to provisions of these rules of alternative medicine shall not lead to growth in volumes of the budgetary appropriations provided in the federal budget for the corresponding financial year and planning period.

4. Ceased to be valid according to the Order of the Government of the Russian Federation of 25.07.2024 No. 1009

5. The minimum assortment is created for different types of the pharmaceutical organizations and individual entrepreneurs according to international non-proprietary names of medicines (in the absence of such names - according to grouping or chemical names) of the medicines for medical application answering to the following criteria:

a) medicine is registered in accordance with the established procedure in the Russian Federation;

b) medicine is included into the list of the major medicines;

c) the medicine which is in circulation in the territory of the Russian Federation has at least 2 corresponding to it according to the international non-proprietary name or the grouping or chemical name of the reproduced or bioanalog (biosimilar) medicines replacing such name in the similar dosage forms and dosages made by two and more producers (except for the medicines made by the single domestic manufacturer);

d) medicine according to data on sales volumes in the pharmaceutical market of the Russian Federation is demanded by health care system and the population during all calendar year.

6. Medicines are excluded from the list of the major medicines, the list of expensive medicines (further - lists) and the minimum assortment according to the decision of the commission specified in Item 8 of these rules in case of review of the list of the major medicines according to offers of the Ministry of Health of the Russian Federation, the chief non-staff specialist of the Ministry of Health of the Russian Federation (further - the chief expert) and the subject of drug circulation (further - the applicant) with application of documents and the data confirming availability of one of the following cases:

submission of the evidence-based recommendation of the chief expert, stipulated in Item 26 these rules, in case of inclusion in lists therapeutic the similar medicine having the proved clinical, and (or) kliniko-economic benefits, and (or) features of the mechanism of action (further - therapeutic similar medicine) and also if the medicine included in lists is not applied in the existing schemes of therapy;

representation by producer of medicine either the holder or the owner of the registration certificate of medicine of the offer on medicine exception of lists in case of data on toxicity or undesirable reactions in case of use of medicine and availability of reasons for such exception;

suspension of use of medicine in the Russian Federation;

cancellation of state registration (registration) of medicine;

cessation of production of medicine or its deliveries to the Russian Federation, absence during the period exceeding one calendar year, input of medicine in civil circulation in the Russian Federation and lack of remaining balance of medicine in the Russian Federation;

medicine exception of the list of the major medicines - for the list of expensive medicines and the minimum assortment.

The term "subject of drug circulation" is used in these rules in the value established by the Federal Law "About Drug Circulation".

Medicine is subject to exception of lists and the minimum assortment according to this Item and Item 6 (1) these rules in case of approach of one of the cases specified in these Items concerning all equivalent dosage forms of such medicine.

6(1). Medicines are subject to exception of lists and the minimum assortment if within 6 months after inclusion of medicine in the list of the major medicines marginal selling price of the producer on medicine is not registered.

6(2). Lists and the minimum assortment join unicomponent medicines. The combined medicines join in lists if by results of assessment which is carried out according to the subitem "b" of Item 19 of these rules their benefit in application and cost in comparison with unicomponent medicines is proved.

In case of inclusion of the combined medicines in lists and the minimum assortment all unicomponent medicines registered in the Russian Federation of which such combination consists at the same time join.

If at least one component of the combined medicine is not registered and does not address in the territory of the Russian Federation as unicomponent medicine, in case of inclusion in lists and the minimum range of such combined medicine provisions of paragraph one of this Item are not applied.

6(3). Ceased to be valid according to the Order of the Government of the Russian Federation of 25.07.2024 No. 1009

7. The list of the major medicines is created and reviewed at least once a year. The list of expensive medicines and the minimum assortment are created at least once in 3 years.

8. Forming of lists and the minimum assortment is performed the Russian Federation formed by the Ministry of Health by the commission on forming of lists of medicines and the minimum assortment (further - the commission).

9. Modification of lists and the minimum assortment is performed according to provisions of these rules.

9(1). Operational modification of lists and the minimum assortment is performed according to provisions of these rules on the basis and in time which are established by the corresponding order of the Government of the Russian Federation about consideration by the commission of offers on inclusion (about exception) medicines in lists and the minimum assortment.

9(2). Operational entering into the list of the major medicines of changes in part of inclusion of medicines, possible to appointment and application for treatment and the prevention of the diseases constituting danger to people around, provided by methodical recommendations of the Ministry of Health of the Russian Federation in the conditions of emergency situation and (or) in case of threat of spread of such diseases, is performed on representation of the Ministry without application of the provisions established by Items 13 - 35 these rules.

The offers on entering of the specified changes into the list of the major medicines provided by the Ministry of Health of the Russian Federation are subject to operational consideration on commission session with participation of the representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, Federal Service on supervision in health sector, Federal Service for the Oversight of Consumer Protection and Welfare and Federal Antimonopoly Service who are members of the commission. The chief expert, and also the manufacturer representative of medicine for the purpose of consideration and coordination of the price of medicine which the producer plans to register are invited to commission session.

10. Organizational technical supply of activities of the commission performs the Ministry of Health of the Russian Federation.

11. Representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, Ministry of Labour and Social Protection of the Russian Federation, the Federal Service on supervision in health sector, Federal Service for the Oversight of Consumer Protection and Welfare, Federal Antimonopoly Service, Federal Medical Biological Agency, the Ministry of science and the higher education of the Russian Federation, other federal executive bodies and executive bodies of subjects of the Russian Federation in the sphere of health protection, the educational organizations of the higher education realizing educational programs of medical education and the pharmaceutical education subordinated to federal executive bodies and also the medical, pharmaceutical and scientific organizations are part of the commission, subordinated to federal executive bodies (except for such organizations performing complex assessment according to Item 19 of these rules).

At commission session are present at availability of the preliminary address in writing to the commission which arrived not later than 5 working days about day of the corresponding commission session, the applicant's representative, representatives of all producers of medicines and (or) owners (holders) of registration certificates within international non-proprietary names which are offered to consideration, the representative of the public association performing activities in spheres of health care, drug circulation and protection of the rights of citizens in these spheres and also representatives of other federal executive bodies and executive bodies of subjects of the Russian Federation in the sphere of health protection whose representatives are not part of the commission.

12. Commission sessions are broadcast on the official site of the Ministry of Health of the Russian Federation on the Internet (further - the official site in Internet network).

13. The applicant sends no later than the 10th day of the first month of quarter to the commission the following offers in electronic form by means of information and communication technologies with appendix in electronic form of the relevant documents and data:

a) the offer on inclusion of medicine in lists on form according to appendix No. 1;

b) the offer on inclusion of medicine in the minimum assortment on form according to appendix No. 2;

c) the offer on medicine exception of lists on form according to appendix No. 3;

d) the offer on medicine exception of the minimum assortment on form according to appendix No. 4.

14. Ceased to be valid according to the Order of the Government of the Russian Federation of 29.10.2018 No. 1283

15. The commission within 4 working days from the date of receipt of the offers specified in Item 13 of these rules (further - the offer), will organize conducting their documentary examination.

In case of documentary examination proper execution of the offer according to these rules, completeness and reliability of the provided information on medicines, including its compliance to the data containing in the state register of medicines by results of which the conclusion in form according to appendix No. 5 is drawn up (further - the conclusion by results of documentary examination) is checked.

16. The offer is rejected from further review in case of:

a) inadequate execution of the offer and the documents and data attached to it, and also availability in the provided electronic files of the damages which are not allowing to distinguish its content;

b) submission of documents and data in incomplete amount;

c) submission of the offer within 6 months after date of its giving in case of pronouncement by the commission of the decision on refusal in inclusion (in exception) medicine in lists (from lists), the minimum assortment (from the minimum assortment) within the international non-proprietary name of medicine (in the absence of such name - within the grouping or chemical name), except as specified, provided by Items 9 (1) and 9(2) these rules;

d) submission of the offer within 6 months after date of its giving in case of pronouncement by the commission of the decision on inclusion of medicine in the list of the major medicines within the international non-proprietary name of medicine (in the absence of such name - within the grouping or chemical name) - for the medicines offered to inclusion in the list of expensive medicines;

e) submission of the doubtful or distorted information;

e) submission of the offer within 6 months after date of its repeated variation by results of documentary examination.

17. In case of offer variation from further review by the commission the conclusion by results of documentary examination goes to the applicant by means of information and communication technologies in time, not exceeding 3 working days from the date of its removal.

The offer finished by the applicant with the resolved comments specified in the conclusion by results of documentary examination can be repeatedly sent to the commission by means of information and communication technologies no later than 10 working days from the date of receipt of the conclusion by results of documentary examination.

The commission in time, not exceeding 2 working days from the date of receipt of the offer finished by the applicant, will organize conducting repeated documentary examination. Offers concerning which by results of documentary examination the conclusion with notes on discrepancy to the established requirements is taken out deviate from further review by the commission with the direction of the adequate notice on e-mail of the applicant which address is specified in the offer.

18. Information on the offers which arrived to the commission including which passed the documentary examination is posted on the official site in Internet network within 3 working days after completion of documentary examination.

19. By results of documentary examination concerning the medicines offered for inclusion in lists, except for offers concerning which the conclusion with notes on discrepancy to the established requirements is taken out the complex assessment including the following stages is performed:

a) carrying out the Ministry of Health of the Russian Federation by federal state budgetary institution "Center of Examination and Quality Control of Medical Care" (further - the Center of examination) the analysis of methodological quality of kliniko-economic researches of medicines and researches with use of the analysis of influence on budgets of the budget system of the Russian Federation (further - the analysis of methodological quality) according to requirements to methodological quality of kliniko-economic researches of medicine and researches with use of the analysis of influence on budgets of the budget system of the Russian Federation which are given in appendix No. 5(1);

b) conducting examination of kliniko-economic evaluation of medicine by the Center, medicine impact assessments on budgets of the budget system of the Russian Federation, quantitative assessment of additional data on medicine on the basis of integrated scales which are given in appendix No. 6;

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