ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 3, 2020 No. 431

About establishment of features of the address of medical products and restrictions for implementation of wholesale and retail trade with medical products and about the list of such products

According to parts 5.1 and 23 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Determine joint-stock company "Roskhimzashchita Corporation the federal operator - the coordinator on ensuring need of subjects of the Russian Federation for separate types of medical products to which restrictions for implementation of wholesale and retail trade extend, on the list according to appendix (further respectively - goods, the operator-coordinator).

2. Authorize as regional operators of the organization, having the license for implementation of pharmaceutical activities regarding wholesale trade by medicines for medical application and supplying medicines according to 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, the aplastic anemia which is not specified, heritable deficit of factors of II (fibrinogen), the VII (labile), X (Stewart - Prauera), persons after organ transplantation and (or) fabrics, approved by the order of the Government of the Russian Federation of November 26, 2018 No. 1416 "About procedure for the organization of providing persons with medicines, patients 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, the aplastic anemia which is not specified, heritable deficit of factors of II (fibrinogen), the VII (labile), X (Stewart - Prauera), persons after organ transplantation and (or) fabrics, and also about recognition voided some acts of the Government of the Russian Federation", in subjects of the Russian Federation (further - regional operators).

3. To heads of executive bodies of subjects of the Russian Federation in the field of health protection in time, not exceeding 3 days from the date of entry into force of this resolution to provide to the operator-coordinator of the data on the current inventories of goods in the organizations located in the territory of appropriate subject of the Russian Federation and about inventories of goods for operation of this resolution (in kind), and also about the need for goods (in kind for operation of this resolution, monthly) for providing the population of the subject of the Russian Federation with them.

4. Establish prohibition for the organizations of any forms of business, except for the operator-coordinator and (or) regional operators, on wholesale of the operators-coordinators and (or) regional operators made from the date of entry into force of this resolution of goods to the organizations of any forms of business, except for.

5. Establish prohibition on retail purchase and sale of goods from the date of entry into force of this resolution for the organizations which do not have the license for implementation of pharmaceutical activities regarding retail trade by medicines for medical application and (or) leave of medicines for medical application.

6. Set restriction of free alienation in the territory of the Russian Federation of goods, except for the actions provided by this resolution.

7. Determine that for each stage of goods distribution chain of the wholesale supplies of goods the size of the wholesale allowance to the actual selling prices shall not exceed 10 percent from the purchase price or cost of goods including the price of the supplier, direct customs, transportation and logistic expenses.

8. Determine that for each stage of goods distribution chain of the wholesale supplies of the goods made before entry into force of this resolution, the size of the wholesale allowance to the actual selling prices shall not exceed 10 percent from the purchase price or cost of goods including the price of the supplier, direct customs, transportation and logistic expenses.

9. Determine that for the organizations of retail trade having the license for implementation of pharmaceutical activities regarding retail trade by medicines for medical application and (or) leave of medicines for medical application, the extreme size of the retail allowance to the actual selling prices on goods shall not exceed 10 kopeks for commodity unit (product).

10. As spread of new koronavirusny infection is the force and impreventable majeure which entailed introduction of high alert according to the Federal Law "About Protection of the Population and the Territories against Emergency Situations of Natural and Technogenic Nature", non-execution of obligations of producers and suppliers of goods according to current contracts (agreements) on their delivery (sale) is considered as the taking place owing to force majeure.

11. Determine that non-compliance with the features of the address of medical products and restrictions for implementation of wholesale and retail trade with medical products established by this resolution is violation of restrictive actions, including sanitary and anti-epidemic, and involves responsibility, stipulated by the legislation the Russian Federation.

12. To heads of executive bodies of the subjects of the Russian Federation realizing powers in the field of industrial policy and trading activity:

in 3-day time from the date of entry into force of this resolution to provide the round-the-clock control of implementation of this resolution;

to weekly represent reporting materials to the Ministry of Industry and Trade of the Russian Federation for the purpose of realization of paragraph two of this Item.

13. This resolution becomes effective from the date of its official publication, except for items 4 and 5 these resolutions, and is effective within 90 calendar days.

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