ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of July 25, 2024 No. 1009

About modification of the Order of the Government of the Russian Federation of August 28, 2014 No. 871

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to 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" (The Russian Federation Code, 2014, No. 36, Art. 4855; 2017, No. 25, Art. 3691; 2018, No. 45, Art. 6943; No. 48, Art. 7431; 2020, No. 24, Art. 3795; No. 34, Art. 5445; No. 50, Art. 8226).

2. To the Ministry of Health of the Russian Federation together with the Ministry of Industry and Trade of the Russian Federation, Federal Antimonopoly Service taking into account provisions, stipulated in Item 2 (regarding forming of the list of vital and essential drugs for medical application with indication of basic element or additional element of dosage forms, including in need of type of release of active ingredient) and the paragraph the sixth Item 6 of 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 medicines necessary for delivery of health care" (further - Rules of forming of lists) (in edition of this resolution) to provide till October 15, 2024 preparation of offers on modification of the list of vital and essential drugs for medical application, the list of the medicines intended for providing persons sick with hemophilia, mukovistsidozy, by hypophysial nanism, 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 - lists of medicines), and the minimum range of medicines, necessary for delivery of health care, for the purpose of their consideration on commission session 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 (further - the commission), without application of the provisions established by Items 13 - 28 Rules of forming of lists (in edition of this resolution), and adoption of relevant decisions by the commission till December 10, 2024.

3. Offers on inclusion (about exception) medicines for medical application in lists of medicines (from lists of medicines) and the minimum range of the medicines necessary for delivery of health care (from the minimum range of the medicines necessary for delivery of health care), the entries into force of this resolution given the subject of drug circulation about one day and not considered on commission session are subject to consideration on the commission session according to the procedure provided by Rules of forming of lists (in edition of this resolution), within 90 days from the date of entry into force of this resolution without application of the provisions established by Items 13 - 28 Rules of forming of lists (in edition of this resolution).

4. Offers on inclusion of medicines for medical application in the lists of medicines and the minimum range of the medicines necessary for delivery of health care considered on commission session before entry into force of this resolution (except for offers on which the commission makes the decision on their variation), are subject to de novo review on the commission session according to the procedure provided by Rules of forming of lists (in edition of this resolution), within 90 days from the date of entry into force of this resolution without application of the provisions established by Items 13 - 28 Rules of forming of lists (in edition of this resolution).

5. Recognize invalid Items 3 and 7 of changes which are made to 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 December 3, 2020 No. 2021 "About modification 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 Russian Federation Code, 2020, No. 50, the Art. 8226).

Approved by the Order of the Government of the Russian Federation of July 25, 2024 No. 1009

Changes which are made to the Order of the Government of the Russian Federation of August 28, 2014 No. 871

1. In word preamble "According to articles 55 and 60 of the Federal law "About Drug Circulation", article 44 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" and article 6.2 of the Federal law "About the Government Public Assistance" to exclude.

2. In 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 specified resolution:

Item 2 to state 1) in the following edition:

"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.";

Item 4 to declare 2) invalid;

Item 6 to state 3) in the following edition:

"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.";

The second paragraph one of Item 6 (2) words "estimates of economic effects of their application and studying of additional effects of use of medicines (further - complex assessment)" shall be replaced with words 4) in the offer "assessment which is carried out according to the subitem "b" of Item 19 of these rules";

5) Item 6 (to declare 3) invalid;

Item 11 to state 6) in the following edition:

"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 the field of health care, 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 field 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 field of health protection which representatives are not part of the commission.";

In paragraph one of Item 15 of the word "7 working days" shall be replaced with words 7) "4 working days";

To state Item 16 in the following edition:

"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.";

Item 17 to add 9) with the paragraph of the following content:

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