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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 22, 2014 No. 968

About procedure for forming of lists of medical products

(as amended on 10-10-2019)

According to part 2 of article 80 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" and part 2 of article 6.2 of the Federal law "About the Government Public Assistance" Government of the Russian Federation decides:

1. Approve the enclosed Rules of forming of lists of medical products.

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 medical products and its structure.

3. Determine that in 2014 offers on forming of lists of medical products go to the Ministry of Health of the Russian Federation according to the procedure, provided by the Rules approved by this resolution till October 6, 2014.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of September 22, 2014 No. 968

Rules of forming of lists of medical products

1. These rules determine procedure for forming:

a) the list of the medical products implanted into human body in case of delivery of health care within the program of the state guarantees of free rendering medical care to citizens (further - the program of the state guarantees);

b) the list of the medical products released according to recipes on medical products by provision of set of social services.

2. Lists of medical products, stipulated in Item 1 these rules (further - lists), are created by types of the medical products meeting the following requirements:

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

b) the type of medical product is included in the nomenclature classification of medical products approved by the Ministry of Health of the Russian Federation;

c) application of medical product in the Russian Federation is not suspended.

3. The list of medical products provided by the subitem "an" of Item 1 of these rules is created by types of the medical products answering in addition to the requirements specified in Item 2 of these rules, to the following requirements:

a) there are reasons (data of clinical testing, reports of producers (manufacturers) on results of practical application, results of kliniko-economic evaluation of producers (manufacturers), results of monitoring of safety of medical product) for inclusion of medical product in standards of medical care, clinical recommendations (protocols of treatment) concerning rendering specialized medical care, including high-technology medical care according to the established list of types of high-technology medical care;

b) the total volume of production and (or) deliveries of medical product of the corresponding type registered in the Russian Federation in accordance with the established procedure covers requirements of rendering specialized medical care, including high-technology medical care according to the established list of types of high-technology medical care, within the program of the state guarantees.

4. The list of medical products provided by the subitem "b" of Item 1 of these rules is created by types of the medical products answering in addition to the requirements specified in Item 2 of these rules, to the requirement about availability of possibility of independent use by the patient of medical product for the purpose of carrying out medical research and (or) in case of medicine introduction.

5. The medical product is subject to exception of lists if it does not correspond at least to one of the requirements provided by Items 2 - 4 these rules.

6. Forming of lists is performed at least once in 2 years taking into account amount of the budgetary appropriations provided in the federal budget on financial provision of the program of the state guarantees and rendering the government public assistance.

7. Modification of lists is performed according to provisions of these rules.

8. Forming of lists is performed the Russian Federation formed by the Ministry of Health by the commission on forming of lists of medical products (further - the commission).

9. Organizational technical supply of activities of the commission is performed by the Ministry of Health of the Russian Federation.

10. 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, Federal Antimonopoly Service, Federal Service for the Oversight of Consumer Protection and Welfare, Federal Service on supervision in health sector, the Ministries of science and the higher education of the Russian Federation and Federal Medical Biological Agency, experts (non-staff specialists) of the Ministry of Health of the Russian Federation, and also representatives of the federal state educational organizations of the higher medical education, the state medical, scientific organizations and community of doctors are part of the commission.

11. Subjects of the address of medical products, the medical, scientific medical and (or) pharmaceutical organizations, and also the public associations performing activities in spheres of health care, the address of medical products, protection of the rights of citizens in the sphere of health protection (further - applicants), send to the Ministry of Health of the Russian Federation no later than March 1 of the current year of the offer on inclusion of medical product in the list or about exception of medical product of the list (further - offers) in form according to appendix.

12. In case of the direction of offers by mail the date specified on postage stamp of the organization of federal mail service in the place of departure of the offer is considered day of the appeal of the applicant to the commission.

13. The offer goes the applicant on paper or in electronic form with appendix of the relevant documents and data. The applicant also has the right to provide other data proving inclusion of medical product in the list or its exception of the list, on paper or in electronic form.

14. Information on the offers which arrived in the commission is posted in accordance with the established procedure on the official site of the Ministry of Health of the Russian Federation in is information - telecommunication network "Internet" (further - Internet network).

15. Consideration of offers is performed by the commission in time, not exceeding 30 working days from the date of their obtaining.

If in the specified time the offer cannot be considered, the commission makes the decision on prolongation of term of its consideration, but no more than for 30 days on what the Ministry of Health of the Russian Federation notifies the applicant. The adequate notice can be transferred to the authorized representative of the applicant personally on receipt, is directed by mail by the registered mail or transferred electronically with use of Internet network.

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