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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 30, 2021 No. 1871

About approval of Rules for apportionment, realization and leaves of drugs and psychotropic substances, and also realization and leaves of their precursors and recognition voided some acts and separate provisions of some acts of the Government of the Russian Federation

According to article 23 of the Federal law "About Drugs and Psychotropic Substances" Government of the Russian Federation decides:

1. Approve the enclosed Rules for apportionment, realization and leaves of drugs and psychotropic substances, and also realization and leaves of their precursors.

2. Recognize invalid acts and separate provisions of acts of the Government of the Russian Federation according to the list according to appendix.

3. This resolution becomes effective since March 1, 2022.

The rules approved by this resolution are effective till March 1, 2028.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of October 30, 2021 No. 1871

Rules for apportionment, realization and leaves of drugs and psychotropic substances, and also realization and leaves of their precursors

1. These rules establish procedure for distribution, realization and leave of the drugs and psychotropic substances included in the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, No. 681 approved by the order of the Government of the Russian Federation of June 30, 1998 "About approval of the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation" (further - the list), and also realization and leaves of the precursors entered in the list I of the list (further - precursors).

2. Distribution of drugs and psychotropic substances is performed by the state unitary enterprises and public institutions. Distribution of the psychotropic substances entered in the list III of the list is performed by other legal entities irrespective of patterns of ownership.

Realization and leave of drugs, psychotropic substances and precursors are performed by legal entities irrespective of patterns of ownership.

Distribution, realization and leave of drugs and psychotropic substances, and also realization and leave of precursors are made by legal entities in the presence of license for activities on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants with indication of the corresponding works and services in distribution, realization and (or) leave of drugs, psychotropic substances and precursors.

3. Distribution of the drugs and psychotropic substances used in the medical purposes and (or) in veterinary science is performed according to the plan of distribution of drugs and psychotropic substances which is annually approved by the Ministry of Industry and Trade of the Russian Federation (further - the plan of distribution).

4. The legal entities performing distribution of the drugs and psychotropic substances used in the medical purposes and (or) in veterinary science (further - authorized organizations), make distribution of drugs and psychotropic substances to the particular legal entities subordinated to federal executive bodies, and (or) the legal entities registered in the territory of the subject of the Russian Federation (further - the organizations), according to the requests of the organizations for receipt of specific drugs and psychotropic substances represented in the established form (further - the request).

5. In case of submission of requests to authorized organization calculation of need for the drugs and psychotropic substances used in the medical purposes is performed by the organizations proceeding from the standard rates approved by the Ministry of Health of the Russian Federation, and concerning drugs and the psychotropic substances used in veterinary science - proceeding from the standard rates approved by the Ministry of Agriculture of the Russian Federation.

6. In the request are specified:

a) data on the organization;

b) registration number and date of provision of the license for activities which is available for the organization for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants;

c) names of drugs and psychotropic substances, their form of release, dosage form, dosage, packaging and quantity;

d) reasons for calculations of need for drugs and psychotropic substances according to Item 5 of these rules.

7. The request is signed by the head of the organization, certified by seal (in the presence) this organization and it is represented in authorized organization no later than September 15. The head of the organization bears the personal responsibility for justification and reliability of the submitted request.

8. The authorized organization according to the submitted requests creates the summary request in the established form and represents it to federal executive body under which authority is, or in authorized body of the executive authority of the subject of the Russian Federation.

9. In the summary request are specified:

a) data on authorized organization;

b) registration number and date of provision of the license for activities which is available for authorized organization for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants;

c) names of drugs and psychotropic substances, their form of release, dosage form, dosage, packaging and quantity.

10. The summary request is signed by the head of federal executive body or authorized body of the executive authority of the subject of the Russian Federation and it is represented in the Ministry of Industry and Trade of the Russian Federation no later than October 15.

11. The legal entities performing in accordance with the established procedure production, production and import to the Russian Federation of drugs and psychotropic substances (except for the pharmaceutical organizations performing production of the medicines containing drugs and psychotropic substances), create data on the planned production volumes, production and import to the Russian Federation of the drugs and psychotropic substances used in the medical purposes and (or) in veterinary science in the established form (further - data on the planned amounts) which include:

a) the information about the legal entity performing production, production or import to the Russian Federation of drugs and psychotropic substances;

b) registration number and date of provision of the license for activities which is available for the legal entity on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants;

c) names of drugs and psychotropic substances, their form of release, dosage form, dosage, packaging and quantity.

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