ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 26, 2018 No. 1416

About procedure for the organization of providing persons with medicines 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, persons after organ transplantation and (or) fabrics, and also about recognition voided some acts of the Government of the Russian Federation

According to Item 21 of part 2 of Article 14 and parts 7 - the 9th article 44 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of the organization of providing persons with medicines 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, persons after organ transplantation and (or) fabrics;

Rules of maintaining the Federal register 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, persons after organ transplantation and (or) fabrics;

list of invalid acts of the Government of the Russian Federation.

2. To the Ministry of Health of the Russian Federation in the procedure established by the legislation of the Russian Federation to conduct procurement for 2019 of medicines for pathogenetic treatment of persons sick with gemolitiko-uraemic syndrome, juvenile arthritis with the system beginning, the mukopolisakharidozy I, II and VI types included in the list of vital and essential drugs.

3. To make to the Ministry of Health of the Russian Federation explanations on application of the rules approved by this resolution.

4. This resolution becomes effective since January 1, 2019, except for Item 2, which becomes effective from the date of official publication of this resolution.

Approved by the Order of the Government of the Russian Federation of November 26, 2018 No. 1416

Rules of the organization of providing persons with medicines 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, persons after organ transplantation and (or) fabrics

1. These rules establish procedure for the organization of providing 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, persons after organ transplantation and (or) fabrics (further - patients), the medicines for medical application intended for treatment of these diseases according to the list of medicines approved by the Government of the Russian Federation created in the procedure established by it (further - medicines), and also procedure and conditions of transfer of medicines to property of subjects of the Russian Federation.

2. Source of financing of the organization of providing patients with medicines are the budgetary appropriations provided in the federal budget to the Ministry of Health of the Russian Federation.

3. The patient's right to providing with medicines arises from the date of inclusion of information about him in regional segment of the Federal register 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, persons after organ transplantation and (or) fabrics (further - the Federal register).

Date of inclusion of the patient in regional segment of the Federal register is fixed by the attending physician in the medical record of the outpatient or history of development of the child.

4. The organization of providing with the Ministry of Health of the Russian Federation at the expense of means of the federal budget of patients with medicines is performed taking into account standards of medical care, clinical recommendations (protocols of treatment) and average course dose of medicines.

5. Public authorities of subjects of the Russian Federation in the sphere of health protection no later than November 1 of the current year submit to the Ministry of Health of the Russian Federation supply requisitions of medicines in the form approved by the specified Ministry (further - requests), with appendix of reasons on their amount, and also the list of the organizations having the license for implementation of medical and (or) pharmaceutical activities in subjects of the Russian Federation (further - the organizations receivers), for the purpose of delivery to the organizations receivers of medicines.

The need (scope of supply) for medicine is determined taking into account clinical recommendations (protocols of treatment) and average course dose of medicine proceeding from monthly actual demand of patients in medicines according to data of regional segment of the Federal register and need of stock forming for 15 months.

6. The Ministry of Health of the Russian Federation creates the commission on consideration of requests (further - the commission), approves regulations on the commission and its structure. The commission at the meeting considers requests regarding justification of the declared amounts of medicines, if necessary adjusts them, and approves with pronouncement of the relevant decision.

Coordination of requests is performed by the commission with participation of representatives of public authorities of subjects of the Russian Federation (including with use of information and communication technologies).

7. The supply rate of medicines is created within the budgetary appropriations provided in the Federal Law on the federal budget for the corresponding financial year and planning period and limits of the budget obligations brought in accordance with the established procedure to the Ministry of Health of the Russian Federation on purchase of medicines.

8. According to the supply rates of medicines approved by public authorities of subjects of the Russian Federation in the sphere of health protection taking into account the decision of the commission, the Ministry of Health of the Russian Federation in the procedure established by the legislation of the Russian Federation conducts procurement of medicines.

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