Order 1085 on licensing. Legislative framework of the Russian Federation. With changes and additions from

Valid Editorial from 04.09.2012

Name of document	Decree of the Government of the Russian Federation dated December 22, 2011 N 1085 (as amended on September 4, 2012, with amendments that came into force on September 18, 2012) “ON LICENSING ACTIVITIES FOR TRANSPORT OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, TIVATION OF DRUG-CONTAINING PLANTS"
Document type	decree, regulation
Receiving authority	Russian government
Document Number	1085
Acceptance date	18.09.2012
Revision date	04.09.2012
Date of registration with the Ministry of Justice	01.01.1970
Status	valid
Publication	The document was not published in this form (as amended on 12/22/2011 - “Collection of Legislation of the Russian Federation”, 01/02/2012, No. 1, Art. 130, "Rossiyskaya Gazeta", N 2, 01/11/2012)
Navigator	Notes

Decree of the Government of the Russian Federation dated December 22, 2011 N 1085 (as amended on September 4, 2012, with amendments that came into force on September 18, 2012) “ON LICENSING ACTIVITIES FOR TRANSPORT OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, TIVATION OF DRUG-CONTAINING PLANTS"

In accordance with the Federal Law "On Licensing of Certain Types of Activities", the Government of the Russian Federation decides:

1. Approve the attached Regulations on licensing activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.

2. Recognize the acts of the Government of the Russian Federation as invalid in accordance with the appendix.

Chairman of the Government
Russian Federation
V. PUTIN

APPROVED
Government Decree
Russian Federation
dated December 22, 2011 N 1085

REGULATIONS ON LICENSING ACTIVITIES FOR TRAFFICKING OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION OF DRUG-CONTAINING PLANTS

dated 05/24/2012 N 507, dated 09/04/2012 N 882)

1. These Regulations establish the procedure for licensing activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants carried out by legal entities and individual entrepreneurs.

Activities related to the circulation of narcotic drugs, psychotropic substances and their precursors included in Lists I - III and Table I of List IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 30, 1998, are subject to licensing. N 681 (hereinafter referred to as the list), and the cultivation of narcotic plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of November 27, 2010 N 934, for use for scientific, educational purposes and in expert activities (hereinafter referred to as the cultivation of narcotic plants).

2. Activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants include work and services in accordance with the Appendix.

3. Licensing of activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants is carried out by the following licensing authorities:

a) Federal Service for Surveillance in Healthcare - regarding the implementation of:

(as amended by Decrees of the Government of the Russian Federation dated September 4, 2012 N 882)

activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, carried out by:

Organizations of wholesale trade of medicines;

from January 1, 2012 - pharmacy organizations subordinate to federal executive authorities, state academies of sciences;

activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in List I of the list;

activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List;

Activities related to the cultivation of narcotic plants;

B) executive authorities of the constituent entities of the Russian Federation - in terms of carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list (with the exception of activities for the circulation of narcotic drugs and psychotropic substances in the part carried out by the Federal Service for Surveillance in Healthcare ).

(as amended by Decrees of the Government of the Russian Federation dated September 4, 2012 N 882)

4. An applicant for a license to carry out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants (hereinafter referred to as the license) must meet the following licensing requirements:

dated August 6, 1998 N 892;

c) compliance by the license applicant who intends to carry out activities related to the trafficking of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, cultivation of narcotic plants, articles and

D) compliance by the license applicant who intends to carry out activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List, paragraphs - and Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

e) the presence on the staff of a license applicant who intends to carry out activities related to the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, and precursors included in list I of the list, employees with secondary vocational, higher professional, additional professional education and (or) special training in the field of trafficking in narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed.

5. When carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants, the licensee must comply with the following licensing requirements:

a) the presence of the following belonging to him by right of ownership or on another legal basis and meeting the established requirements:

premises and equipment necessary for carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants;

land plots necessary for the cultivation of narcotic plants;

B) compliance with the procedure for admitting persons to work with narcotic drugs and psychotropic substances, as well as to activities related to the circulation of precursors of narcotic drugs and psychotropic substances, established by Decree of the Government of the Russian Federation of August 6, 1998 N 892;

c) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, cultivation of narcotic plants, with the requirements of articles and the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

D) compliance by the licensee developing new narcotic drugs and psychotropic substances included in lists I - III of the list, as well as precursors of narcotic drugs and psychotropic substances included in list I of the list, with the requirements of Article 16 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" ;

e) compliance by the licensee processing narcotic drugs and psychotropic substances included in lists I - III of the list of Article 19 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their processing established by Decree of the Government of the Russian Federation of February 24, 2009 N 147 ;

f) compliance by the licensee storing narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, with the requirements of Article 20 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their storage established by Government Decree Russian Federation dated December 31, 2009 N 1148;

G) compliance by the licensee transporting narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, with the requirements of Article 21 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their transportation, as well as registration the documents necessary for this, established by Decree of the Government of the Russian Federation of June 12, 2008 N 449;

H) compliance by the licensee dispensing, selling narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, and distribution of these narcotic drugs and psychotropic substances, with the requirements of Article 23 of the Federal Law "On Narcotic Drugs and psychotropic substances" and the procedure for their distribution, release and sale, established by Decree of the Government of the Russian Federation of July 26, 2010 N 558;

i) compliance by the licensee dispensing narcotic drugs and psychotropic substances included in lists II and III of the list, according to prescriptions containing the prescription of narcotic drugs and psychotropic substances, with the requirements of the articles and the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

K) compliance by the licensee carrying out the production of narcotic drugs, psychotropic substances and their precursors included in list I of the list, for the purpose of producing analytical (standard) samples and producing analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, with the requirements of Article 17 Federal Law "On Narcotic Drugs and Psychotropic Substances";

K) compliance by the licensee carrying out the production and manufacture of narcotic drugs and psychotropic substances included in lists II and III of the list with the requirements of the articles and the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

l) compliance by the licensee carrying out the destruction of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, with the requirements of Article 29 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their destruction established by Government Decree Russian Federation dated June 18, 1999 N 647;

H) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the List with the requirements of paragraphs and Article 30 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

n) compliance by the licensee using narcotic drugs and psychotropic substances included in lists II and III for medical purposes with the requirements of Article 31 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

P) compliance by the licensee using narcotic drugs and psychotropic substances included in lists II and III in veterinary medicine with the requirements of Article 33 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their use in veterinary medicine, established by Decree of the Government of the Russian Federation dated 3 September 2004 N 453;

p) compliance by the licensee using narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I and table I of list IV of the list, for scientific and educational purposes, as well as in expert activities, with the requirements of the articles and the Federal Law “On narcotic drugs and psychotropic substances”;

c) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list with the requirements of Article 37 of November 4, 2006 N 644;

T) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list with the requirements of Article 39 of November 4, 2006 N 644;

U) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, rules for the development, production, manufacture, storage, transportation, shipment, release, sale, distribution, acquisition, use, import into the customs territory Russian Federation, export from the customs territory of the Russian Federation, destruction of instruments and equipment that are under special control and used for the production and manufacture of narcotic drugs, psychotropic substances established by Decree of the Government of the Russian Federation of March 22, 2001 N 221;

F) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in List I and Table I of List IV of List, the requirements of Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for submitting reports on activities related to them turnover established by Decree of the Government of the Russian Federation of June 9, 2010 N 419;

x) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in List I and Table I of List IV of List, the requirements of Article 39 of the Federal Law “On Narcotic Drugs and Psychotropic Substances” and the procedure for maintaining and storing special transaction logs, related to their turnover, established by Decree of the Government of the Russian Federation of June 9, 2010 N 419;

v) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List, the procedure for production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances, established by Government Resolution Russian Federation dated August 18, 2010 N 640;

h) the presence on the staff of a licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, employees with secondary vocational, higher professional, additional professional education and (or) special training in the field of trafficking in narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed;

Ш) advanced training of specialists with pharmaceutical and medical education carrying out activities related to the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, at least once every 5 years.

6. Carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants in gross violation of licensing requirements entails liability established by the legislation of the Russian Federation.

In this case, a gross violation is understood as the licensee’s failure to comply with the requirements provided for in subparagraphs “a” - “p”, “t” - “y”, “x” and “c” of paragraph 5 of these Regulations, entailing the consequences provided for in Part 11 of Article 19 Federal Law "On Licensing of Certain Types of Activities".

7. To obtain a license, the license applicant sends or submits an application to the licensing authority (when performing work (rendering services) provided for in paragraphs 2, 3, 11, 15, 16, 23, 27, 28, 39, 43, 44, 55, 63 appendices to these Regulations - indicating specific narcotic drugs and psychotropic substances included in lists I - III of the list, and precursors included in list I and table I of list IV of the list) and documents (copies of documents) specified in part 1 and paragraphs , and Part 3 of Article 13 of the Federal Law “On Licensing of Certain Types of Activities”, as well as:

a) copies of documents that confirm that the applicant has a license on the right of ownership or on another legal basis that meets the established requirements and is necessary for carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, equipment, premises and land plots, the right to which are not registered in the Unified State Register of Rights to Real Estate and Transactions with It (if such rights are registered in the said register - information about these premises and land plots);

b) a copy of a specialist’s certificate confirming the appropriate professional training of the head of a legal entity or the head of the relevant department of a legal entity in the trafficking of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, and the cultivation of narcotic plants;

C) copies of certificates issued by state or municipal health care institutions in the manner established by the legislation of the Russian Federation, confirming that employees who, in accordance with their official duties, must have access to narcotic drugs, psychotropic substances, as well as precursors included in List I and Table List I of List IV, or cultivated narcotic plants, diseases of drug addiction, substance abuse, chronic alcoholism;

D) information on the availability of conclusions from the authority for control over the circulation of narcotic drugs and psychotropic substances, provided for in paragraphs three and five of paragraph 3 of Article 10 and paragraph three of paragraph 7 of Article 30 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

e) copies of documents on the education of persons engaged in trafficking in narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, as well as on the qualifications of pharmaceutical and medical workers.

8. If you intend to carry out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants at an address not specified in the license, in the application for re-issuance of the license, the licensee indicates this address and also submits:

a) information containing a new address for carrying out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants;

paragraph 3 of article 10 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

D) information about a specialist certificate confirming the appropriate professional training of the head of a unit of a legal entity located at a new address in the trafficking of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, and the cultivation of narcotic plants .

9. If you intend to perform work (provide a service) for the cultivation of narcotic plants that was not previously specified in the license, the licensee in the application for renewal of the license indicates this work (service), and also submits:

A) information about new work (service) for the cultivation of narcotic plants that the licensee intends to perform (provide);

b) copies of documents that confirm that the applicant has a license on the right of ownership or on another legal basis that meets the established requirements and is necessary for carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, equipment, premises and land plots, the right to which are not registered in the Unified State Register of Rights to Real Estate and Transactions with It (if such rights are registered in the said register - information about these premises and land plots);

c) information about the presence of a conclusion from the authority for control over the circulation of narcotic drugs and psychotropic substances, provided for in paragraph 3 of paragraph 3 of Article 10 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”.

10. When checking the information contained in the application submitted by the license applicant (licensee) and the documents attached to it, the compliance of the license applicant (licensee) with licensing requirements, the licensing authority requests the information necessary for licensing from bodies providing public services, bodies providing municipal services , other state bodies, local government bodies or organizations subordinate to them in the manner established by the Federal Law “On the organization of the provision of state and municipal services”.

11. The licensing authority places in the federal state information system "Unified portal of state and municipal services (functions)" in the manner established by the Government of the Russian Federation, information on the progress of its decision to grant or re-issue a license, checking the compliance of the license applicant and the licensee with licensing requirements provided for in paragraphs 4 and 5 of these Regulations.

12. Information related to the implementation of activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, provided for by parts and Article 21 of the Federal Law "On Licensing of Certain Types of Activities", is posted in the official electronic or printed media of the licensing authority and (or) on information stands on the premises of the licensing authority within 10 days from the date:

b) the licensing authority makes a decision on granting, re-issuing, suspending, renewing, or terminating a license;

C) receiving information from the Federal Tax Service on the liquidation of a legal entity or termination of its activities as a result of reorganization, on the termination by an individual of activities as an individual entrepreneur;

d) the entry into force of a court decision to revoke the license.

13. Licensing control is carried out in the manner prescribed by the Federal Law "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control", taking into account the specifics of organizing and conducting inspections established by the Federal Law "On Licensing of Certain Types of Activities" .

14. Submission by the license applicant of an application and documents necessary to obtain a license, and their acceptance by the licensing body, the licensing body making a decision to grant a license (to refuse to grant a license), to re-issue a license (to refuse to re-issue a license), suspension, renewal, termination the validity of the license, as well as the provision of a duplicate and copy of the license, the formation and maintenance of a licensing case, the maintenance of a register of licenses and the provision of information contained in the register of licenses are carried out in the manner established by the Federal Law “On Licensing of Certain Types of Activities”.

When the licensing authority makes a decision to grant a license providing for the performance of works and services specified in paragraphs 2, 3, 11, 15, 16, 23, 27, 28, 39, 43, 44, 55, 63 of the appendix to this Regulation, in the license the names of specific narcotic drugs, psychotropic substances and (or) precursors are indicated in accordance with the articles of the Federal Law “On Narcotic Drugs and Psychotropic Substances”.

15. Maintaining a consolidated register of licenses, including licenses issued by executive authorities of constituent entities of the Russian Federation in accordance with delegated powers, is carried out by the Federal Service for Surveillance in Healthcare.

(as amended by Decrees of the Government of the Russian Federation dated September 4, 2012 N 882)

17. For the provision or re-issuance of a license by the licensing authority, or the issuance of a duplicate license on paper, a state fee is paid in the amounts and in the manner established by the legislation of the Russian Federation on taxes and fees.

APPENDIX TO THE REGULATIONS

Application
to the Licensing Regulations
drug trafficking activities
drugs, psychotropic substances
and their precursors, cultivation
narcotic plants

LIST OF WORKS AND SERVICES CONTAINING ACTIVITIES FOR TRAFFICKING OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION OF DRUG-CONTAINING PLANTS

dated May 24, 2012 N 507)

1. Development of new narcotic drugs and psychotropic substances included in List I of the list

2. Production of narcotic drugs and psychotropic substances included in list I of the list

3. Production of analytical (standard) samples of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

4. Processing of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

5. Storage of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

6. Transportation of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

7. Sales of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

8. Dispensing (except for dispensing to individuals) of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

9. Distribution of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

10. Purchase of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

11. Use of narcotic drugs and psychotropic substances included in list I of the list

12. Use of narcotic drugs and psychotropic substances included in list I of the list

13. Destruction of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

14. Development of new precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

15. Production of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, for the purpose of producing analytical (standard) samples.

16. Production of analytical (standard) samples of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

17. Processing of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

18. Storage of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

19. Transportation of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

20. Dispensing (except for dispensing to individuals) of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

21. Sales of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

22. Purchase of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

23. Use of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation for scientific and educational purposes.

24. The use of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation in expert activities.

25. Destruction of precursors of narcotic drugs and psychotropic substances included in List I of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

26. Development of new narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

27. Production of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

28. Manufacture of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

29. Processing of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

30. Storage of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

31. Transportation of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

32. Dispensing to individuals narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

33. Dispensing (except for dispensing to individuals) of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

34. Sales of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

35. Distribution of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

36. Purchase of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

37. Use of narcotic drugs and psychotropic substances included in list II of the list

38. Use of narcotic drugs and psychotropic substances included in list II of the list

39. The use of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation for scientific and educational purposes.

40. The use of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation, in expert activities.

41. Destruction of narcotic drugs and psychotropic substances included in List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

42. Development of new psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

43. Production of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

49. Dispensing (except for dispensing to individuals) of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

50. Sales of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

51. Distribution of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

52. Purchase of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

53. Use of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation for medical purposes.

54. The use of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation, in veterinary medicine.

55. The use of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation for scientific and educational purposes.

56. The use of psychotropic substances included in List III of the list of narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation, in expert activities.

Narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

61. Sales of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

62. Purchase of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

(as amended by Decree of the Government of the Russian Federation dated May 24, 2012 N 507)

64. Cultivation of narcotic plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and subject to control in the Russian Federation, for

3. Decree of the Government of the Russian Federation of April 7, 2008 N 249 “On approval of the Regulations on licensing activities related to the circulation of narcotic drugs and psychotropic substances included in List I in accordance with the Federal Law “On Narcotic Drugs and Psychotropic Substances” (Meeting Legislation of the Russian Federation, 2008, No. 15, Art. 1556).

4. Paragraph three of paragraph 1 of the Decree of the Government of the Russian Federation of June 12, 2008 N 449 “On the procedure for transporting narcotic drugs, psychotropic substances and their precursors on the territory of the Russian Federation, as well as processing the documents necessary for this” (Collection of Legislation of the Russian Federation, 2008 , N 25, art. 2982).

5. Points and changes that are made to the acts of the Government of the Russian Federation regulating the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of December 31, 2009 N 1148 (Collected Legislation of the Russian Federation, 2010, N 4, Art. 394 ).

6. Items and changes that are made to acts of the Government of the Russian Federation on issues of state control (supervision), approved by Decree of the Government of the Russian Federation of April 21, 2010 N 268 (Collected Legislation of the Russian Federation, 2010, N 19, Art. 2316).

7. Decree of the Government of the Russian Federation of May 11, 2010 N 318 “On approval of the Regulations on licensing activities related to the production, processing, storage, sale, acquisition and use of precursors of narcotic drugs and psychotropic substances included in Table I of List IV in accordance with the Federal Law “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 2010, No. 20, Art. 2473).

legislation of the Russian Federation, 2010, N 45, art. 5863).

11. Paragraph three of the Decree of the Government of the Russian Federation of December 10, 2010 N 1012 “On licensing the cultivation of plants containing narcotic drugs or psychotropic substances or their precursors for use for scientific, educational purposes and in expert activities” (Collection of Legislation of the Russian Federation, 2010, No. 51, Art. 6943).

12. Clause 3 of the Decree of the Government of the Russian Federation of July 20, 2011 N 599 “On control measures in relation to drugs that contain small quantities of narcotic drugs, psychotropic substances and their precursors included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" (Collected Legislation of the Russian Federation, 2011, No. 30, Art. 4648).

The website “Zakonbase” contains the RF Government DECREE dated 12/22/2011 N 1085 (as amended on 09/04/2012 with amendments that entered into force on 09/18/2012) “ON LICENSING ACTIVITIES FOR TRANSPORT OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PREPARATIONS” CURSORS, CULTIVATION OF DRUGS CONTAINING PLANTS" in the latest edition. It is easy to comply with all legal requirements if you read the relevant sections, chapters and articles of this document for 2014. To find the necessary legislative acts on a topic of interest, you should use convenient navigation or advanced search.

On the Zakonbase website you will find the RF Government DECREE dated 12/22/2011 N 1085 (as amended on 09/04/2012 with amendments that entered into force on 09/18/2012) "ON LICENSING ACTIVITIES FOR TRANSPORT OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION DRUG-CONTAINING PLANTS" in a fresh and complete version, in which all changes and amendments have been made. This guarantees the relevance and reliability of the information.

At the same time, download the RESOLUTION of the Government of the Russian Federation dated December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) “ON LICENSING ACTIVITIES FOR TRANSPORT OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION OF DRUG-CONTAINING PLANTS" is possible completely free, both in full and in individual chapters.

The pharmacy must have a maximum of 3 licenses to carry out:

Pharmaceutical activities;

Activities related to the turnover of NS and PV of List 2;

Activities related to the turnover of substances of List 3.

Licensing for this type of activity is carried out in the same way as for pharmaceutical activities, but the premises in which NS and PV are stored are separately licensed.

This premises must have permission from the Ministry of Internal Affairs of the Russian Federation, as well as permission to work with NS and PV for employees and an order from the head of the pharmacy for persons authorized to work with NS and PV.

Licensing of activities related to the circulation of NS and PV.

Licensing of NS and DP is carried out in accordance with Federal Law No. 3, which establishes the legal basis of state policy in the field of circulation of NS and DP and in the field of combating their illegal trafficking in order to protect the health of citizens, state and public safety.

Requirements for the main types of activities related to the turnover of NS and PE.

In the Russian Federation, there is a state monopoly on the main types of activities related to the circulation of NS and DP (plant cultivation, development, processing, distribution, destruction of NS and DP). The production of NS and PV is carried out by state or municipal unitary enterprises. Violation of a state monopoly entails liability in accordance with the legislation of the Russian Federation.

Federal Law-3 establishes the following requirements and conditions:

Activities related to the circulation of NS and PV can be carried out by a legal entity, the management of which includes a specialist with appropriate professional training (pharmacy manager);

Legal entities must provide conditions for ensuring the accounting and safety of NS and PV, as well as ensuring the safety of such activities (drug room; security and fire alarm with output to the private security console; safes weighing less than 1 ton must be attached to the floor or wall; NS stock and PV monthly; there are bars on the windows; two doors);

A legal entity can carry out this activity if it has the following documents:

Certificate of a specialist, head of a legal entity or head of a pharmacy or head of the relevant department of a legal entity;

Certificates issued by institutions of the state or municipal ZO system confirming the absence of employees who, due to their official duties, will have access directly to NS and PV;

Conclusions of the State Drug Control Agency on the absence of outstanding or unexpunged convictions for employees for crimes of medium gravity, a serious crime or a crime related to the illegal trafficking of NS.

The license requirements or conditions are:

Availability of premises on the right of ownership, corresponding to sanitary, fire safety standards and rules;

Availability of material and technical equipment;

Compliance with technical strength requirements;

Compliance with the rules of storage, accounting, release, destruction, use of NS and PV;

Compliance with the rules for storing NS and PV that have flammable and explosive properties;

Compliance with the requirements by persons authorized to work with NS and PV;

Availability of employees, pharmacists, pharmacists;

The head of the legal entity has professional training and experience of at least 3 years.

To obtain a license, the applicant provides:

Statement;

Copies of constituent documents;

Copies of the certificate of registration with the tax authority;

Payment of state duty;

Certificates of specialists;

Copies of diplomas;

Certificates from psychiatric, drug treatment and the Ministry of Internal Affairs;

Conclusion of the Ministry of Internal Affairs on compliance with the established requirements for technical strength and equipment with security alarms.

TOPIC 4. LEGISLATIVE FOUNDATIONS OF BUSINESS ACTIVITY IN PHARMACY

Lecture No. 1. The concept of individuals and legal entities. Basic provisions of the Civil Code of the Russian Federation on individuals and legal entities. Procedure for registering a legal entity. Legal capacity of an individual. Individual entrepreneurial activity. The procedure for registering a legal entity and individual entrepreneur. Commercial and non-profit organizations.

Chairman of the Government of the Russian Federation

Regulations on licensing activities for the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants

Licensing is subject to activities related to the circulation of narcotic drugs, psychotropic substances and their precursors included in Lists IIII and Table I of List IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998. No. 681 (hereinafter referred to as the list), and the cultivation of narcotic plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of November 27, 2010 No. 934, for use for scientific, educational purposes and in expert activities (hereinafter referred to as the cultivation of narcotic plants).

other organizations and individual entrepreneurs in terms of licensing control (with the exception of licensees who have submitted applications for renewal of licenses), powers to suspend, renew and cancel licenses;

Judicial practice and legislation - Decree of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on July 4, 2017) “On licensing activities for the circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants” (together with the “Regulations on licensing activities for trafficking in narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants")

- Decree of the Government of the Russian Federation dated December 22, 2011 N 1085 “On licensing activities for the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants”, which established the Regulations for licensing activities for the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation narcotic plants, as well as a list of works and services constituting this activity (came into force on January 10, 2012);

GOVERNMENT OF THE RUSSIAN FEDERATION

RESOLUTION

On licensing of activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants

Document with changes made:
(Rossiyskaya Gazeta, N 121, 05/30/2012);
(Collection of Legislation of the Russian Federation, No. 37, 09/10/2012);
(Official Internet portal of legal information www.pravo.gov.ru, 08/10/2015, N 0001201508100002);
(Official Internet portal of legal information www.pravo.gov.ru, 09.27.2016, N 0001201609270001) (for the procedure for entry into force, see paragraph 2 of the Decree of the Government of the Russian Federation dated September 23, 2016 N 956);
Decree of the Government of the Russian Federation of July 4, 2017 N 791 (Official Internet portal of legal information www.pravo.gov.ru, 07/06/2017, N 0001201707060009).
____________________________________________________________________

In accordance with the Government of the Russian Federation

decides:

1. Approve the attached Regulations on licensing activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.

2. Recognize the acts of the Government of the Russian Federation as invalid in accordance with the appendix.

Chairman of the Government
Russian Federation
V.Putin

Regulations on licensing activities for the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants

APPROVED
Government resolution
Russian Federation

Licensing is subject to activities related to the circulation of narcotic drugs, psychotropic substances and their precursors included in lists I-III and table I of list IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by decree of the Government of the Russian Federation of June 30, 1998 year N 681 (hereinafter referred to as the list), and the cultivation of narcotic plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of November 27, 2010 N 934, for use for scientific, educational purposes and in expert activities (hereinafter referred to as the cultivation of narcotic plants).

a) Federal Service for Surveillance in Healthcare - regarding the implementation of:

activities related to the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, carried out by:

drug wholesale trade organizations;

pharmacy organizations subordinate to federal executive authorities;

other organizations and individual entrepreneurs in terms of licensing control (with the exception of licensees who have submitted applications for renewal of licenses), powers to suspend, renew and cancel licenses;

activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in List I of the list;

activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List;

activities related to the cultivation of narcotic plants;
Decree of the Government of the Russian Federation of September 23, 2016 N 956.

b) executive authorities of the constituent entities of the Russian Federation - in terms of carrying out activities related to the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list (in terms of issuing and re-issuing licenses, providing duplicate licenses and copies of licenses, exercising licensing control in relation to license applicants and licensees who submitted applications for renewal of licenses, termination of licenses, formation and maintenance of registers of licenses issued by public authorities of the constituent entities of the Russian Federation, approval of application forms for the provision and renewal of licenses, approval of notification forms, extracts from the specified registers of licenses and others used in the licensing process documents, as well as providing interested parties with information on licensing issues, including posting this information on the Internet information and telecommunications network on the official websites of government bodies of the constituent entities of the Russian Federation, indicating email addresses to which users of this information can send requests and receive requested information) carried out:

organizations, with the exception of wholesale trade organizations in medicines and pharmacy organizations subordinate to federal executive authorities;

the paragraph became invalid on July 14, 2017 - Decree of the Government of the Russian Federation dated July 4, 2017 N 791.
(Subclause as amended, put into effect on October 3, 2016 by Decree of the Government of the Russian Federation dated September 23, 2016 N 956.

premises and equipment necessary for carrying out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (with the exception of medical organizations and separate divisions of medical organizations located in rural settlements and areas remote from settlements in which there are no pharmacy organizations (hereinafter referred to as medical organizations and separate divisions of medical organizations);
Decree of the Government of the Russian Federation of August 6, 2015 N 807.

a_1) whether a medical organization has a license to carry out medical activities (if the applicant for the license is a medical organization);
Decree of the Government of the Russian Federation of August 6, 2015 N 807)

;

c) compliance by the license applicant who intends to carry out activities related to the trafficking of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, cultivation of narcotic plants, articles 5 and;

d) compliance by the license applicant who intends to carry out activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List, paragraphs 5 - and;

e) the presence on the staff of a license applicant who intends to carry out activities related to the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, list of list I, of workers with secondary vocational, higher vocational, additional vocational education and (or) special training in sphere of circulation of narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed.

a) the presence of the following belonging to him by right of ownership or on another legal basis and meeting the established requirements:

premises and equipment necessary for carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (with the exception of medical organizations and separate divisions of medical organizations);
(Paragraph as amended, put into effect on August 18, 2015 by Decree of the Government of the Russian Federation dated August 6, 2015 N 807.

land plots necessary for the cultivation of narcotic plants;

a_1) whether a medical organization has a license to carry out medical activities (if the licensee is a medical organization);
(The subparagraph was additionally included on August 18, 2015 by Decree of the Government of the Russian Federation of August 6, 2015 N 807)

b) compliance with the procedure for admitting persons to work with narcotic drugs and psychotropic substances, as well as to activities related to the circulation of precursors of narcotic drugs and psychotropic substances, established by Decree of the Government of the Russian Federation of August 6, 1998 N 892;

c) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, cultivation of narcotic plants, with the requirements of Articles 5 and 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" ;

d) compliance by the licensee developing new narcotic drugs and psychotropic substances included in lists I-III of the list, as well as precursors of narcotic drugs and psychotropic substances included in list I of the list, with the requirements of Article 16 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" ;

e) compliance by the licensee processing narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, with the requirements of Article 19 of the Federal Law “On Narcotic Drugs and Psychotropic Substances” and the procedure for their processing established by government decree Russian Federation dated February 24, 2009 N 147;

f) compliance by the licensee storing narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, with the requirements of Article 20 of the Federal Law “On Narcotic Drugs and Psychotropic Substances” and the procedure for their storage, established by government decree Russian Federation dated December 31, 2009 N 1148;

g) compliance by the licensee transporting narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, with the requirements of Article 21 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their transportation, as well as registration the documents necessary for this, established by Decree of the Government of the Russian Federation of June 12, 2008 N 449;

h) compliance by the licensee dispensing, selling narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, and distribution of these narcotic drugs and psychotropic substances, with the requirements of Article 23 of the Federal Law "On Narcotic Drugs and psychotropic substances" and the procedure for their distribution, release and sale, established by Decree of the Government of the Russian Federation of July 26, 2010 N 558;

i) compliance by the licensee dispensing narcotic drugs and psychotropic substances included in lists II and III of the list, according to prescriptions containing the prescription of narcotic drugs and psychotropic substances, with the requirements of Articles 25 and 26 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

j) compliance by the licensee carrying out the production of narcotic drugs, psychotropic substances and their precursors included in list I of the list, for the purpose of producing analytical (standard) samples and producing analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, with the requirements of Article 17 Federal Law "On Narcotic Drugs and Psychotropic Substances";

k) compliance by the licensee carrying out the production and manufacture of narcotic drugs and psychotropic substances included in lists II and III of the list with the requirements of Articles 17 and 27 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

l) compliance by the licensee carrying out the destruction of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, with the requirements of Article 29 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their destruction established by government decree Russian Federation dated June 18, 1999 N 647;

m) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List with the requirements of paragraphs 5 and 11 of Article 30 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

o) compliance by the licensee using narcotic drugs and psychotropic substances included in lists II and III for medical purposes with the requirements of Article 31 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

p) compliance by the licensee using narcotic drugs and psychotropic substances included in lists II and III in veterinary medicine with the requirements of Article 33 of the Federal Law “On Narcotic Drugs and Psychotropic Substances” and the procedure for their use in veterinary medicine, established by Decree of the Government of the Russian Federation dated 3 September 2004 N 453;

p) compliance by the licensee using narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I and table I of list IV of the list, for scientific and educational purposes, as well as in expert activities, with the requirements of Articles 34 and 35 Federal Law "On Narcotic Drugs and Psychotropic Substances";

c) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list with the requirements;

r) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list with the requirements of Decree of the Government of the Russian Federation of November 4, 2006 N 644;

s) compliance by the licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, rules for the development, production, manufacture, storage, transportation, shipment, release, sale, distribution, acquisition, use, import into the customs territory Russian Federation, export from the customs territory of the Russian Federation, destruction of instruments and equipment that are under special control and used for the production and manufacture of narcotic drugs, psychotropic substances, established by Decree of the Government of the Russian Federation of March 22, 2001 N 221;

t) compliance by the licensee carrying out activities in the circulation of precursors of narcotic drugs and psychotropic substances included in List I and Table I of List IV of List, the requirements of Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for submitting reports on activities related to them turnover established;

v) compliance by the licensee carrying out activities related to the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of List, the procedure for production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances, established by a Government resolution Russian Federation dated August 18, 2010 N 640;

w) the presence on the staff of a licensee carrying out activities in the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, employees with secondary vocational, higher professional, additional professional education and (or) special training in the field of trafficking in narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed;

x) advanced training of specialists with pharmaceutical and medical education carrying out activities related to the circulation of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, at least once every 5 years.

7. To obtain a license, the license applicant sends or submits an application to the licensing authority (when performing work (rendering services) provided for in paragraphs 2, 3, 11, 15, 16, 23, 27, 28, 39, 43, 44, 55, 63 appendices to these Regulations - indicating specific narcotic drugs and psychotropic substances included in lists I-III of the list, and precursors included in list I and table I of list IV of the list) and documents (copies of documents) specified in part 1 and paragraphs 1, 3 and 4 of Part 3 of Article 13 of the Federal Law “On Licensing of Certain Types of Activities”, as well as:

a_1) information about the availability of a license to carry out medical activities (if the licensee is a medical organization);
(The subparagraph was additionally included on August 18, 2015 by Decree of the Government of the Russian Federation of August 6, 2015 N 807)

b) a copy of a specialist’s certificate confirming the appropriate professional training of the head of a legal entity or the head of the relevant department of a legal entity in the trafficking of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, and the cultivation of narcotic plants;

c) copies of certificates issued by state or municipal health care institutions in the manner established by the legislation of the Russian Federation, confirming that employees who, in accordance with their official duties, have access to narcotic drugs, psychotropic substances, as well as precursors included in List I and Table List I of List IV, or cultivated narcotic plants, diseases of drug addiction, substance abuse, chronic alcoholism;

d) information about the availability of conclusions from the authority for control over the circulation of narcotic drugs and psychotropic substances, provided for in paragraphs three and five of paragraph 3 of Article 10 and paragraph three of paragraph 7 of Article 30 of the Federal Law “On Narcotic Drugs and Psychotropic Substances”;

e) copies of documents on the education of persons engaged in trafficking in narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, as well as on the qualifications of pharmaceutical and medical workers.

a) information containing a new address for carrying out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants;

a_1) information about the availability of a license to carry out medical activities, indicating the new address for carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (for medical organizations);
(The subparagraph was additionally included on August 18, 2015 by Decree of the Government of the Russian Federation of August 6, 2015 N 807)

;

d) information about a specialist certificate confirming the appropriate professional training of the head of a unit of a legal entity located at a new address in the trafficking of narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the list, and the cultivation of narcotic plants .

a) information about new work (service) for the cultivation of narcotic plants that the licensee intends to perform (provide);

12. Information related to the implementation of activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, provided for in parts 1 and 2 of Article 21 of the Federal Law "On Licensing of Certain Types of Activities", is posted in the official electronic or printed media of the licensing entity authority and (or) on information stands on the premises of the licensing authority within 10 days from the date:

b) the licensing authority makes a decision on granting, re-issuing, suspending, renewing, or terminating a license;

c) receiving information from the Federal Tax Service on the liquidation of a legal entity or termination of its activities as a result of reorganization, on the termination by an individual of activities as an individual entrepreneur;

d) the entry into force of a court decision to revoke the license.

16. On a monthly basis, before the 10th day, the executive authorities of the constituent entities of the Russian Federation send in printed and electronic form the data contained in the registers of licenses of the constituent entities of the Russian Federation to the Federal Service for Surveillance in Healthcare.
(Clause as amended, put into effect on September 18, 2012 by Decree of the Government of the Russian Federation dated September 4, 2012 N 882.

18. The Federal Service for Surveillance in Healthcare sends, within 5 working days, to the state authorities of the constituent entities of the Russian Federation exercising the powers specified in paragraph 1 of part 1 of Article 15 of the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, certified copies of orders on suspension and renewal of licenses, appointment of inspections of licensees, copies of inspection reports of licensees, orders to eliminate identified violations of licensing requirements, protocols on administrative offenses, decisions on the imposition of administrative penalties and other documents related to the implementation of license control in relation to licensees (except for licensees who submitted applications for renewal of licenses) carrying out activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants, for inclusion in licensing cases.
(The paragraph was additionally included on October 3, 2016 by Decree of the Government of the Russian Federation dated September 23, 2016 N 956)

Application. List of works and services that constitute activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants

Application
to the Licensing Regulations
drug trafficking activities
drugs, psychotropic substances and their
precursors, cultivation
narcotic plants