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Ministry of Justice

Russian Federation 

On September 29, 2014 No. 34182

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of September 9, 2014 No. 498n

About approval of the 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

(as amended of the Order of the Ministry of Health of the Russian Federation of 15.03.2019 No. 128n)

According to Item 2 of 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 official Internet portal of legal information http://www.pravo.gov.ru, on September 1, 2014, to No. 0001201409010015), I order:

1. Create 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 (further - the Commission).

2. Approve regulations on the Commission according to appendix.

Minister

V. I. Skvortsova

Appendix

to the Order of the Ministry of Health of the Russian Federation of September 9, 2014 No. 498n

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

1. 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 (further - the Commission), is created for the purpose of forming of the following projects:

the list of vital and essential drugs (further - the list of the major medicines);

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, and also persons after organ transplantation and (or) fabrics (further - the list of expensive medicines);

the list of medicines for medical application, including the medicines for medical application appointed according to the decision of the medical commissions of the medical organizations (further - the list of medicines for ensuring separate categories of citizens);

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

2. The commission in the activities is guided by the Constitution of the Russian Federation, the Federal constitutional Laws, the Federal Laws, acts of the President of the Russian Federation and the Government of the Russian Federation, departmental regulatory legal acts, this Provision.

3. Representatives of the Ministry of Health of the Russian Federation (further - the Ministry), the Ministry of Industry and Trade of the Russian Federation, the 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, the federal state educational organizations of the higher medical and pharmaceutical education, and also the federal state medical and pharmaceutical scientific organizations <1> are part of the Commission.

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<1> Item 11 Corrected 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 (The official Internet portal of legal information http://www.pravo.gov.ru, on September 1, 2014, No. 0001201409010015).

4. According 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 <1> (further - Rules), the Commission performs the following functions:

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<1> Official Internet portal of legal information http://www.pravo.gov.ru, on September 1, 2014, No. 0001201409010015.

1) collection arriving to the Ministry from the subjects of drug circulation and (or) public associations performing activities in spheres of health care, drug circulation and protection of the rights of citizens in these spheres (further - applicants), offers with appendix of the relevant documents and data on inclusion of medicine in the list of the major medicines will organize, the list of expensive medicines, the list of medicines for ensuring separate categories of citizens (further - lists), the minimum assortment or about exception of lists, the minimum assortment (further respectively - the offer in lists, the offer in the minimum assortment);

2) will be organized by conducting documentary examination of offers in lists, offers in the minimum assortment, including preparation of the conclusions by its results (further - the conclusion of documentary examination);

3) placement on the official site of the Ministry on the Internet (further - the official site in Internet network) will organize information on the offers which arrived to the Commission in lists, the offers in the minimum assortment including which passed the documentary examination;

4) is sent to the applicant by the negative conclusion of documentary examination with indication of offer reasons for rejection to lists, offers in the minimum assortment from further review;

5) in case of the positive conclusion of documentary examination sends offers to lists with provision of access to their electronic versions with the enclosed documents and data by means of information and communication technologies:

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