THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of November 23, 2020 No. 10949

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2020, No. 31, the Art. 5027), the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; 2018, No. 46, the Art. 7050), the subitem "an" of Item 3 of the Regulations on licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants, No. 1085 approved by the order of the Government of the Russian Federation of December 22, 2011 "About licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants" (The Russian Federation Code, 2012, No. 1, Art. 130; 2020, to No. 15, of the Art. 2304), I order:

Approve the enclosed Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants.

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of November 23, 2020, No. 10949

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants (further respectively - Administrative regulations, the state service), establish terms and the sequence of ministerial procedures (actions) of the Federal Service for supervision in the field of health care (further - Roszdravnadzor), and its territorial authorities (further - territorial authorities) by provision of the state service, and also order of interaction between structural divisions of Roszdravnadzor (territorial authorities), their officials, interactions of Roszdravnadzor (territorial authorities) with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

Circle of applicants

2. Applicants on provision of the state service (further - applicants) are:

1) the legal entities having intention to perform or performing activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants, individual entrepreneurs having intention to perform or performing activities for turnover of precursors of the drugs and psychotropic substances brought in the table I of the list IV of the list of the drugs and psychotropic substances and their precursors which are subject to control in the Russian Federation, No. 681 <1> approved by the order of the Government of the Russian Federation of June 30, 1998 (further - the list), (further respectively - the license applicant, the licensee) or their authorized representatives;

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<1> Russian Federation Code, 1998, No. 27, Art. 3198; 2020, No. 32, Art. 5287.

2) the physical persons and legal entities which addressed for provision of data on specific license for activities on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants.

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed:

on the official site of Roszdravnadzor (territorial authorities) on the Internet (further - the official site of Roszdravnadzor, Internet network);

on the official site in the federal state information system "Single Portal of the State and Municipal Services" (further - the Single portal);

in the federal state information system "Federal Register of the State Services (Functions)" (further - the federal register);

at information stands in reception on work with addresses of citizens;

on phone numbers for reference.

4. Reference information concerning provision of the state service is placed:

on the official site of Roszdravnadzor (territorial authorities);

on the Single portal;

in the federal register;

at information stands of Roszdravnadzor (territorial authorities).

5. Reference information is provided by officials of Roszdravnadzor (territorial authorities) by phone, on personal acceptance of the applicant or in writing the mailing or the electronic message to the address specified by the applicant.

Reference information includes data on the location, the working schedule, telephone numbers for enquiries, number of phone informant, addresses of the official site, e-mail and (or) form of feedback with Roszdravnadzor (territorial authorities).

6. On the official site of Roszdravnadzor (territorial authorities), information stands, on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning provision of the state service;

the exhaustive list of the documents necessary for provision of the state service, the requirement to execution of the specified documents, and also the list of documents which the applicant has the right to provide on own initiative;

circle of applicants;

term of provision of the state service;

data on the course of provision of the state service;

results of provision of the state service;

about the applicant's right to pre-judicial (extrajudicial) appeal of actions (failure to act) and the decisions made (performed) during provision of the state service;

the forms of statements (notifications, messages) used by provision of the state service;

the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

text of Administrative regulations.

7. Information on the Single portal and the official site of Roszdravnadzor (territorial authorities) on procedure and terms of provision of the state service based on the data containing in the federal register is provided to the applicant on a grant basis.

II. Standard of provision of the state service

Name of the state service

8. The state service in licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants.

The name of the body providing the state service

9. The state service is provided by Roszdravnadzor and its territorial authorities:

1) Roszdravnadzor performs licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants in part:

a) activities for drug trafficking and the psychotropic substances entered in lists I, II, III of the list, the wholesale trade performed by the organizations by medicines;

b) activities for turnover of precursors of the drugs and psychotropic substances entered in the list I of the list;

c) the activities for turnover of precursors of the drugs and psychotropic substances brought in the table I of the list IV of the list, performed by the organizations - producers of medicines;

d) cultivation of the narcocontaining plants included in the list of the plants which are containing drugs or psychotropic substances or their precursors and subject to control in the Russian Federation, No. 934 <2> approved by the order of the Government of the Russian Federation of November 27, 2010 for use in the scientific, educational purposes and in expert activities, for production used in the medical purposes and (or) in veterinary science of drugs and psychotropic substances, and also the narcocontaining plant opium poppy included in the specified list of plants in the industrial purposes which are not connected with production or production of drugs and psychotropic substances (further - cultivation of the narcocontaining plants).

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<2> Russian Federation Code, 2010, No. 50, Art. 6696; 2020, No. 32, Art. 5287.

2) territorial authorities perform licensing of activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants in part:

a) the activities for drug trafficking and the psychotropic substances entered in lists I, II, III of the list performed by the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences;

b) activities for turnover of precursors of the drugs and psychotropic substances brought in the table I of the list IV of the list (except for the activities performed by the organizations - producers of medicines).

10. It is forbidden to demand from the applicant of implementation of actions the, including approvals necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and are provided by the organizations participating in provision of the state services, No. 352 <3 approved by the order of the Government of the Russian Federation of May 6, 2011> (further - the List of services).

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<3> Russian Federation Code, 2011, No. 20, Art. 2829; 2020, No. 39, Art. 6038.

Description of result of provision of the state service

11. Results of provision of the state service are:

1) provision (refusal in provision) licenses;

2) renewal (refusal in renewal) licenses;

3) provision of data from the register of licenses;

4) cancellation of the license according to the statement of the licensee.

The term of provision of the state service, including taking into account need of the appeal to the organizations participating in provision of the state service, the term of suspension of provision of the state service if the possibility of suspension is stipulated by the legislation the Russian Federation, the term of issue (direction) of the documents which are result of provision of the state service

12. The term of provision of the state service and issue (direction) of the documents which are result of provision of the state service:

1) decision making about provision (about refusal in provision) licenses - 45 working days from the date of receipt in Roszdravnadzor, territorial authority of properly issued application for provision of the license and documents (data), stipulated in Item 15 Administrative regulations;

2) decision making about renewal (about refusal in renewal) licenses (in cases of reorganization of the legal entity in the form of transformation, merge, change of its name, the location address, the termination of activities for one or several addresses) - 10 working days from the date of receipt in Roszdravnadzor (territorial authority) of properly issued application for renewal of the license and documents (data) provided by Items 16 and 19 of Administrative regulations;

3) decision making about renewal (about refusal in renewal) licenses (in cases of change of addresses of places of implementation by the legal entity of the licensed type of activity, the list of the performed works constituting the licensed type of activity) - 30 working days from the date of receipt in Roszdravnadzor, territorial authority of properly issued application for renewal of the license and documents (data) provided by Items 17 and 18 of Administrative regulations;

4) the direction of the notification on provision (renewal) of the license - 3 working days after day of entering of record about provision (renewal) of the license into the register of licenses;

5) the direction of the notification on refusal in provision (renewal) of the license - 3 working days from the date of signing of the order on refusal in provision (renewal) of the license;

6) cancellation of the license according to the statement of the licensee - 10 working days from the date of receipt of the statement, stipulated in Item 20 Administrative regulations;

7) provision of data from the register of licenses - 3 working days from receipt date in Roszdravnadzor, territorial authority of the statement, stipulated in Item 21 Administrative regulations;

13. The term of suspension of provision of the state service - 30 calendar days from the date of receipt by the applicant of the notification of Roszdravnadzor, territorial authority about need of elimination of the revealed violations and (or) submission of documents which were absent <4>:

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<4> Part 8 of Article 13, part 12 of article 18 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" (The Russian Federation Code, 2011, No. 19, Art. 2716; 2020, No. 31, the Art. 5029) (further - the Federal Law of May 4, 2011 No. 99-FZ).

1) in case of filing of application about provision of the license, Item 15 of Administrative regulations which is drawn up with violation, and (or) submission of documents not in full;

2) in case of filing of application about renewal of the license, drawn up with violation of Items 16 - 19 Administrative regulations, and (or) submission of documents not complete amount.

The regulatory legal acts regulating provision of the state service

14. The list of the regulatory legal acts regulating provision of the state service is posted on the official site of Roszdravnadzor (territorial authorities) in the federal register and on the Single portal.

The exhaustive list of the documents necessary according to regulatory legal acts for provision of the state service and services which are necessary and obligatory for provision of the state service, subject to representation by the applicant, methods of their obtaining by the applicant, including electronically, procedure for their representation

15. For receipt of the license the license applicant represents (sends) the following documents (data) to Roszdravnadzor (territorial authority):

1) the statement for provision of license for activities on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants in form according to Appendix No. 1 to Administrative regulations in which are specified:

a) complete and (if is available) the abbreviated name, including trade name, and form of business of the legal entity, the address of its location, the address of places of implementation of the licensed type of activity which the license applicant intends to perform the state registration number of record about creation of the legal entity, data of the document confirming the fact of entering of information about the legal entity into the Unified State Register of Legal Entities with indication of the location address of the body which performed state registration and also phone numbers, and (if is available) e-mail addresses of the legal entity;

b) identification taxpayer number, data of the document on statement of the license applicant on accounting in tax authority;

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