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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 15, 2020 No. 507

About temporary procedure for distribution in the Russian Federation of test systems for diagnosis of new koronavirusny infection

(as amended on 14-04-2021)

According to article 5 of the Federal law "About Sanitary and Epidemiologic Wellbeing of the Population" and for the purpose of providing the measures directed to decrease in risks of spread of new koronavirusny infection, the Government of the Russian Federation decides:

1. Approve the enclosed temporary procedure for distribution in the Russian Federation of test systems for diagnosis of new koronavirusny infection.

2. Determine Federal Service for the Oversight of Consumer Protection and Welfare authorized federal executive body by accounting and distribution according to the temporary procedure approved by this resolution, made (made) in the territory of the Russian Federation the organizations subordinated to federal executive bodies (except for the organizations subordinated to the Ministry of Defence of the Russian Federation), test systems for diagnosis of new koronavirusny infection, and also by accounting of information on the researches conducted in the Russian Federation on diagnosis of new koronavirusny infection and about their results.

3. This resolution becomes effective from the date of its official publication and is effective till May 1, 2022.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of April 15, 2020, No. 507

Temporary procedure for distribution in the Russian Federation of test systems for diagnosis of new koronavirusny infection

1. This document determines procedure for distribution in the Russian Federation of test systems for diagnosis of new koronavirusny infection (further - test systems) which are developed and are made made) by the organizations subordinated to federal executive bodies (except for the organizations subordinated to the Ministry of Defence of the Russian Federation), and also procedure for exchange of information about amounts and results of diagnostic testings.

2. The organizations irrespective of their forms of business which are developers, producers (manufacturers) of test systems (further - producers), weekly (in the 1st day of the week) send to federal budgetary institution of health care "Federal center of hygiene and epidemiology" of Federal Service for the Oversight of Consumer Protection and Welfare (further - organization) on electronic communication channels (or other available method in coordination) information on amounts of the made (made) in the territory of the Russian Federation test systems the forthcoming calendar week, month and 2 months.

Producers - the federal budgetary institutions performing production of test systems at the expense of subsidies from the federal budget also send to organization in the terms specified in paragraph one of this Item, information on test systems ready to distribution on a grant basis for the purpose of conducting diagnostic testings by the public and local government offices.

3. The Federal Customs Service sends to the Federal Service on supervision in health sector and organization on electronic communication channels (or other available method in coordination) information on amounts of the test systems imported on the territory of the Russian Federation (with indication of the information about the producer and the supplier), in day of movement of the corresponding goods through frontier of the Russian Federation.

4. The Federal Service on supervision in health sector in process of implementation of state registration of test systems, but is at least once a week, provides in organization information on the registered test systems with indication of their producers, and also according to Item of 10 features of the address of the medical products, including state registration of series (batch) of medical product approved by the order of the Government of the Russian Federation of April 3, 2020 No. 430 "About features of the address of medical products including state registration of series (batch) of medical product", about the unregistered test systems which are in circulation.

5. The organizations irrespective of their forms of business performing according to the legislation in the field of ensuring sanitary and epidemiologic wellbeing of the population work with causative agents of infectious diseases of the person III and IV groups of pathogenicity in the territory of appropriate subject of the Russian Federation (further - the organizations performing diagnostic testings), send weekly (to the 1st day of the week) in federal budgetary institutions of health care (the centers of hygiene and epidemiology in subjects of the Russian Federation) requests for the forthcoming week about amounts of the planned diagnostic testings on new koronavirusny infection (further - the request) with use of test systems which are developed and are made made) by the organizations subordinated to federal executive bodies (except for the organizations subordinated to the Ministry of Defence of the Russian Federation), including taking into account addresses of citizens, with indication of data on methods of the organization of delivery of the specified test systems.

6. Federal budgetary institutions of health care (the centers of hygiene and epidemiology in subjects of the Russian Federation) provide collection and generalization of requests within the days specified in Item 5 of this document and transfer summary information to territorial authority of Federal Service for the Oversight of Consumer Protection and Welfare which sends them within one working day to organization.

In summary information data on requirements of the public and local government offices performing diagnostic testings in the test systems distributed on a grant basis are separately specified.

7. The organization weekly on the basis of the obtained data creates the draft of the scheduled plan of distribution of test systems which are developed and are made made) by the organizations subordinated to federal executive bodies (except for the organizations subordinated to the Ministry of Defence of the Russian Federation), on the organizations performing diagnostic testings with indication of information on amounts of the test systems distributed on a grant basis between the public and local government offices performing diagnostic testings taking into account the requests which arrived from them (further - the schedule), proceeding from the following criteria:

the illness rate new koronavirusny infection in the subject of the Russian Federation;

level of current demand of the organizations performing diagnostic testings in laboratory researches in the subject of the Russian Federation taking into account addresses of citizens;

quantity and capacities of the laboratories performing diagnostic testings on new koronavirusny infection in the subject of the Russian Federation.

8. The organization weekly (in the 2nd day of the week) sends the prepared draft of the scheduled plan for approval in Federal Service for the Oversight of Consumer Protection and Welfare.

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