ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 29, 2018 No. 1283

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 government of the Russian Federation decides:

Approve the enclosed changes which are made 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" (The Russian Federation Code, 2014, No. 36, Art. 4855; 2017, No. 25, Art. 3691).

Approved by the Order of the Government of the Russian Federation of October 29, 2018 No. 1283

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

1. In Item 2:

a) the paragraph one after words of "standards of medical care" to add with words ", results of clinical approbation of methods of prevention, diagnostics, treatment and rehabilitation";

b) in the subitem "b" of the word of "diseases, syndromes" shall be replaced with words "in case of delivery of health care in case of diseases";

c) declare the subitem "g" invalid.

2. Add Item 6 with the subitem "zh" of the following content:

"g) submission of the evidence-based recommendation of the chief non-staff specialist of the Ministry of Health of the Russian Federation (further - the chief expert) by results of carried out within анатомо - therapeutic and chemical group of information analysis about comparative clinical efficiency and safety of medicine, assessment of economic effects of its application and studying of additional effects of use of medicine (further - complex assessment).".

3. Add with Items 6 (1) and 6(2) following contents:

"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 one-component medicines. The combined medicines join in lists if by results of complex assessment their benefit in application and cost in comparison with one-component medicines is proved.

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

4. In Item 11:

a) in paragraph one:

the words "Ministries of Finance of the Russian Federation" to exclude;

words of "Federal Agency for Scientific Organizations" shall be replaced with words "The ministries of science and the higher education of the Russian Federation";

b) state paragraph two in the following edition:

"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 representative of the subject of the drug circulation and (or) public association performing activities in spheres of health care, drug circulation and protection of the rights of citizens in these spheres (further - the applicant), and also representatives of other federal executive bodies.".

5. The paragraph one of Item 13 to state in the following edition:

"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:".

6. Declare Item 14 invalid.

7. The paragraph one of Item 15 to state in the following edition:

"15. The commission within 7 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.".

8. In Item 16:

a) add the subitem "a" with words ", including impossibility to open them";

b) declare the subitem "b" invalid;

c) state the subitem "g" in the following edition:

"d) representation within one calendar year of documents and data according to which the commission in the current year passed the decision on refusal in inclusion (exception) of medicine in lists, the minimum assortment or concerning which complex assessment, except for case, stipulated in Item 9(1) these rules is performed;".

9. State Item 17 in the following edition:

"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.".

10. In Item 19 of the word to "further review by the commission" shall be replaced with words to "carrying out complex assessment".

11. State Item 20 in the following edition:

"20. The commission in time, not exceeding 2 working days from the date of pronouncement of the positive conclusion by results of documentary examination concerning the medicines offered for inclusion (exception) in lists directs offers with provision of access to their electronic versions with the enclosed documents and data by means of information and communication technologies:

a) in federal state budgetary institution "Center of Examination and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation (further - the Center of examination) for carrying out the analysis of methodological quality of kliniko-economic researches of medicines and researches with use of the analysis of influence on budgets of budget system of the Russian Federation (further - the budget) according to requirements to methodological quality of kliniko-economic researches of medicine and researches with use of the analysis of influence on budgets of budget system of the Russian Federation which are given in appendix No. 5(1), and also for studying of additional effects of use of medicine based on scale of the quantitative assessment of additional data on medicine provided by integral scales of complex assessment of medicine which are given in appendix No. 6;

b) in the profile federal state educational organization of the higher education (medical and (or) pharmaceutical) and (or) additional professional education, the research activities performing as authorized type of activity, or in the medical and (or) pharmaceutical scientific organization subordinated to the Ministry of Health of the Russian Federation or the Ministry of science and the higher education of the Russian Federation (further - the expert organization), for carrying out information analysis about comparative clinical efficiency and safety of medicine, assessment of economic effects of its application on the basis of integral scales which are given in appendix No. 6.".

12. State Item 22 in the following edition:

"22. Complex assessment is carried out by the Center of examination and the expert organizations within 30 working days from the date of obtaining from the commission of the offer.".

13. In Item 23 shall be replaced with words the word "examinations" "complex assessment".

14. Items 24 - 26 to state in the following edition:

"24. Carrying out complex assessment of the kliniko-economic researches of medicine and justification of the kliniko-economic characteristics received in case of their carrying out causing feasibility of inclusion (exception) of medicine in lists provided by the applicant is performed including based on calculation of cost of annual rate of therapy by the offered medicine in comparison with the medicines included in lists proceeding from the estimated price representing statistical median of the prices of the corresponding medicines registered in accordance with the established procedure (in the presence).

In the absence of the prices of medicines registered in accordance with the established procedure comparison and assessment are performed concerning estimated prices on the purchased medicines according to data of electronic platforms on which electronic auctions on purchase of medicines for the state and municipal needs are held. At the same time the estimated price on medicines represents statistical median of the prices of the actual purchases of the reproduced medicines (in the presence).

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