ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 3, 2020 No. 816

About temporary procedure for distribution in the Russian Federation of some medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection

The government of the Russian Federation decides:

1. Approve the enclosed temporary procedure for distribution in the Russian Federation of some medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection.

2. Determine the Ministry of Health of the Russian Federation authorized federal executive body by coordination of distribution between subjects of the Russian Federation of medicines for medical application, possible to appointment and application for prevention and the treatment of new koronavirusny infection made in the Russian Federation and imported into the Russian Federation.

3. This resolution becomes effective from the date of its official publication and is effective till January 1, 2024.

Approved by the Order of the Government of the Russian Federation of June 3, 2020, No. 816

Temporary procedure for distribution in the Russian Federation of some medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection

1. This document determines procedure for distribution by the Ministry of Health of the Russian Federation for medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection, by the list according to appendix No. 1, made in the Russian Federation and imported into the Russian Federation (further - medicines).

Action of Items 2 - 4 this documents does not extend much distributions of the medicine specified in line item of the 9th appendix No. 1 to this document.

2. The producers of medicines and the organizations performing import to the Russian Federation of medicines, weekly in the 1st day of the week, send to the Ministry of Health of the Russian Federation and the Ministry of Industry and Trade of the Russian Federation on electronic communication channels (or other available method in coordination) the plan of supply distribution of medicines for form according to appendix No. 2, made in the Russian Federation or imported into the Russian Federation, with appendix arrived for the specified period from appropriate subjects of drug circulation for medical application and authorized bodies of the executive authority of subjects of the Russian Federation of supply requisitions of medicines (further - the plan of distribution).

3. The supply requisitions of medicines directed by appropriate subjects of drug circulation for medical application and authorized bodies of the executive authority of subjects of the Russian Federation to producers of the medicines and the organizations performing import to the Russian Federation of medicines shall contain data on the name of medicine, release form, the medical organizations in which supply of the purchased medicines, about amount, about terms of such delivery, the number of patients with the confirmed diagnosis of new koronavirusny infection or with suspicion is planned for such diagnosis for the purposes of which providing medicines are bought.

4. The Ministry of Health of the Russian Federation within 2 calendar days from the date of receipt of the plan of distribution:

a) performs together with the Federal Service on supervision in health sector consideration and assessment of the plans of distribution provided for review taking into account the monitoring of availability which is carried out by the Federal Service on supervision in health sector in the medical and pharmaceutical organizations of the medicines included in the list of vital and essential drugs, and also data on incidence of new koronavirusny infection on subjects of the Russian Federation on the current calendar date;

b) makes the decision on coordination of the provided plans of distribution or need of their adjustment taking into account the data specified in the subitem "an" of this Item with indication of specific data on such adjustment, but without reduction of total amounts of supply of medicines;

c) notifies producers of medicines and the organizations performing import to the Russian Federation of medicines on the made decision with appendix of the approved plan of the distribution in electronic form signed by the strengthened qualified digital signature.

5. Concerning the medicine specified in line item of the 9th appendix No. 1 to this document, holders or owners of registration certificates send to the Ministry of Health of the Russian Federation on electronic communication channels (or other available method in coordination) information on unallotted remaining balance of the medicine specified in line item of the 9th appendix No. 1 to this document.

6. The Ministry of Health of the Russian Federation within 2 calendar days from the date of receipt of information specified in Item 5 of this document:

performs distribution of the medicine specified in line item of the 9th appendix No. 1 to this document between federal executive bodies and authorized bodies of the executive authority of subjects of the Russian Federation according to the methodical recommendations or about the corresponding order of the Government of the Russian Federation developed by the Ministry of Health of the Russian Federation;

notifies holders or owners of registration certificates of the medicine specified in line item of the 9th appendix No. 1 to this document on the made decision with appendix of the distribution in electronic form signed by the strengthened qualified digital signature.

Appendix No. 1

to temporary procedure for distribution in the Russian Federation of some medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection

The list of medicines for medical application, possible to appointment and application for prevention and treatment of new koronavirusny infection

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