Order 1085 on licensing. Legislative base of the Russian Federation

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Act Editorial 04.09.2012

Name Document	Decree of the Government of the Russian Federation of 12/22/2011 N 1085 (Ed. Dated 09/04/2012 with changes that have entered into force on September 18, 2012) "On licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants"
Type of document	resolution, Regulation
Accepted by	government of the Russian Federation
Document Number	1085
Date of adoption	18.09.2012
Date of editorial	04.09.2012
Date of registration in the Ministry of Justice	01.01.1970
Status	act
Publication	In this form, the document was not published (as amended from 12/22/2011 - "Meeting of the Legislation of the Russian Federation", 02.01.2012, N 1, Art. 130, "Russian Gazeta", N 2, 11.01.2012)
Navigator	Notes

Decree of the Government of the Russian Federation of 12/22/2011 N 1085 (Ed. Dated 09/04/2012 with changes that have entered into force on September 18, 2012) "On licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants"

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

1. To approve the attached provision on licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants.

2. To recognize the acts of the Government of the Russian Federation in the incident according to the annex.

Chairman of the government
Russian Federation
V.Putin

Approved
Decree of Government
Russian Federation
dated December 22, 2011 N 1085

Regulations on the licensing of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants

dated 24.05.2012 N 507, from 04.09.2012 N 882)

1. This Regulation establishes the procedure for licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants carried out by legal entities and individual entrepreneurs.

Licensing is subject to activity on the turnover of narcotic drugs, psychotropic substances and their precursors listed in Lists I - III and Table I of the list of the IV list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 30, 1998 G. N 681 (hereinafter - the list), and cultivation of drug-containing plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and to be controlled in the Russian Federation, approved by the Decree of the Government of the Russian Federation of November 27, 2010 N 934, For use in scientific, academic purposes and in expert activities (hereinafter - cultivation of drug-containing plants).

2. Activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants include work and services according to the annex.

3. Licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants carry out the following licensing authorities:

a) Federal Health Supervision Service - in terms of implementation:

(as amended by the Decree of the Government of the Russian Federation of 04.09.2012 N 882)

activities on the turnover of narcotic drugs and psychotropic substances entered in the lists I - III List implemented:

Wholesale trade in medicines;

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

activities on the turnover of precursors of narcotic drugs and psychotropic substances listed in the list I list;

activities on the turnover of precursors of narcotic drugs and psychotropic substances entered in Table I list of the IV list;

Activities for the cultivation of drug-containing plants;

B) the executive authorities of the constituent entities of the Russian Federation - in terms of activities on the turnover of narcotic drugs and psychotropic substances listed in the lists I - III of the list (with the exception of activities on the turnover of drugs and psychotropic substances in the part carried out by the Federal Health Supervision Service ).

(as amended by the Decree of the Government of the Russian Federation of 04.09.2012 N 882)

4. The applicant of the license to carry out activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants (hereinafter referred to as the license) must comply with the following license requirements:

dated August 6, 1998 N 892;

c) compliance with the license applicant, having an intention to carry out activities on the turnover of narcotic drugs and psychotropic substances, lists I - III list, precursors listed in the list I list, cultivation of drug-containing plants, articles and

D) compliance with the license applicant, having an intention to carry out activities on the turnover of precursors of narcotic drugs and psychotropic substances, included in Table I of the list of IV List, paragraphs - and Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

e) the presence in the state applicant license having an intention to carry out activities on the turnover of narcotic drugs and psychotropic substances listed in the list I - III list, and precursors listed in the list I list, workers who have a secondary professional, higher professional, additional professional education and (or) special training in the sphere of narcotic drugs, psychotropic substances and their precursors that meet the requirements and nature of the work performed.

5. Licensee when carrying out activities on the turnover of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants must comply with the following license requirements:

a) the presence of ownership owned by him or other legitimate and relevant established requirements:

premises and equipment necessary for carrying out activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants;

land registers required for cultivation of drug-containing 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 turnover of precursors of narcotic drugs and psychotropic substances established by the Decree of the Government of the Russian Federation of August 6, 1998 N 892;

c) compliance with the licensee engaged in the turnover of narcotic drugs and psychotropic substances listed in the list I - III list, precursors listed in the list I list, cultivation of drug-containing plants, the requirements of articles and the federal law "On narcotic drugs and psychotropic substances";

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

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

(e) Compliance with the licensee carrying the storage of narcotic drugs and psychotropic substances listed in the lists I - III list, precursors listed on the list I list, the requirements of Article 20 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their storage established by the Government Decree Of the Russian Federation of December 31, 2009 N 1148;

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

H) compliance with a licensee carrying leave, the sale of narcotic drugs and psychotropic substances listed in the list I - III list, precursors listed in the list I list and the distribution of these narcotic drugs and psychotropic substances, the requirements of Article 23 of the Federal Law "On Narcotic Drugs and psychotropic substances "and the order of their distribution, vacation and implementation established by the Decree of the Government of the Russian Federation of July 26, 2010 N 558;

i) compliance with the licensee carrying out vacation of narcotic drugs and psychotropic substances listed in the lists of the II and III of the list, according to the recipes containing the appointment of narcotic drugs and psychotropic substances, the requirements of articles and the federal law "On narcotic drugs and psychotropic substances";

K) Compliance with a licensee carrying out the production of narcotic drugs, psychotropic substances and their precursors listed in the list I, in order to manufacture analytical (standard) samples and the manufacture of analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, requirements of Article 17 Federal law "On narcotic drugs and psychotropic substances";

L) compliance with the licensee carrying out the production and manufacture of drugs and psychotropic substances listed in the lists of the II and III of the list, the requirements of articles and the federal law "On narcotic drugs and psychotropic substances";

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

N) compliance with the licensee engaged in the turnover of precursors of narcotic drugs and psychotropic substances entered in Table I of the list of IV List, the requirements of paragraphs and Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

o) Compliance with a licensee using narcotic drugs and psychotropic substances made to lists of the II and III of the List, for medical purposes, the requirements of Article 31 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

P) Compliance with the licensee using narcotic drugs and psychotropic substances, listed in lists of the II and III of the List, in veterinary medicine, 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 the Decree of the Government of the Russian Federation from 3 September 2004 N 453;

(p) Compliance with a licensee using narcotic drugs and psychotropic substances made to lists I - III list, precursors listed on List I and table I list of IV list, scientific and educational purposes, as well as in expert activities, requirements of articles and federal law "On narcotic drugs and psychotropic substances";

(c) Compliance with the licensee engaged in the turnover of narcotic drugs and psychotropic substances entered in the lists I - III list, the requirements of Article 37 of November 4, 2006 N 644;

(T) Compliance with the licensee engaged in the turnover of drugs and psychotropic substances, lists I - III List, the requirements of Article 39 of November 4, 2006 N 644;

(U) Compliance with a licensee carrying out activities on the turnover of narcotic drugs and psychotropic substances lists I - III List, rules for the development, production, manufacture, storage, transportation, shipments, vacation, implementation, distribution, acquisition, use, importation into the customs territory Of the Russian Federation, export from the customs territory of the Russian Federation, the destruction of tools and equipment under special control and used for the production and manufacture of narcotic drugs, psychotropic substances established by the Decree of the Government of the Russian Federation of March 22, 2001 N 221;

F) compliance with the licensee engaged in the turnover of precursors of narcotic drugs and psychotropic substances listed in List I and Table I of the list of IV 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 their the turnover established by the Decree of the Government of the Russian Federation of June 9, 2010 N 419;

x) compliance with the licensee engaged in the turnover of precursors of narcotic drugs and psychotropic substances listed in List I and Table I of the list of IV list, the requirements of Article 39 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for maintaining and storing special registration of operations associated with their turnover established by the Decree of the Government of the Russian Federation of June 9, 2010 N 419;

c) Compliance with the licensee engaged in the turnover of precursors of narcotic drugs and psychotropic substances included in Table I of the list of IV list, the procedure for the production, processing, storage, implementation, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances established by the Government Decree Of the Russian Federation of August 18, 2010 N 640;

H) the presence in the state of the licensee operating on the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, precursors listed in the list I list, workers who have a secondary professional, higher professional, additional vocational education and (or) special preparation in the sphere of narcotic drugs, psychotropic substances and their precursors, complying with the requirements and nature of the work performed;

W) Improving the qualifications of specialists with pharmaceutical and medical education operating on the turnover of narcotic drugs and psychotropic substances listed in the list I - III of the list, precursors listed in the list I of the list, at least once every 5 years.

6. Implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants with a gross violation of licensing requirements entails the responsibility established by the legislation of the Russian Federation.

At the same time, under the gross violation it is understood by failure to fulfill the licensee of the requirements provided for by subparagraphs "A" - "R", "T" - "U", "X" and "C" of paragraph 5 of this Regulation, which caused the consequences provided for by Part 11 of Article 19 Federal law "On licensing certain types of activities."

7. To obtain a license, the license applicant sends or submit to the licensing authority a statement (when performing work (provision of services) provided for in paragraphs 2, 3, 11, 15, 16, 23, 27, 28, 39, 43, 44, 55, 63 Annexes to this Regulation - indicating specific narcotic drugs and psychotropic substances entered in the list I - III list, and precursors listed on List I and Table I list IV list) and documents (copies of documents) specified in Part 1 and paragraphs , and paragraph 3 of Article 13 of the Federal Law "On Licensing Some Activities", as well as:

a) copies of documents that confirm the availability of a license for the right of ownership or on the other legitimate basis of the relevant requirements and necessary for the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants of equipment, premises and land plots, rights to which are not registered in the Unified State Register of Rights to Real Estate and Transactions with Him (if such rights are registered in the specified registry - information about these premises and land plots);

b) a copy of the certificate of a specialist confirming the appropriate professional training of the head of a legal entity or the head of the relevant legal entity unit in the implementation of the turnover of narcotic drugs and psychotropic substances, lists I - III List, precursors listed in the list I list, and cultivating drug-containing plants;

C) copies of certificates issued by state or municipal healthcare facilities in the procedure established by the legislation of the Russian Federation, the absence of workers who, in accordance with their official duties, should have access to narcotic drugs, psychotropic substances, as well as precursors listed in List I and Table I list of IV list, or cultivated drug-containing plants, diseases of drug addiction, toxicomic, chronic alcoholism;

D) information on the presence of the conclusions of the body control of narcotic drugs and psychotropic substances provided for by paragraphs of the third and fifth paragraph 3 of Article 10 and paragraph of the third paragraph 7 of Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

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

8. Under the intention to carry out activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants at the address not specified in the license, in a statement of reforming the license, the licensee indicates this address, and also represents:

a) information containing a new address of the activities of the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants;

paragraph 3 of Article 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

D) information on the certificate of a specialist confirming the appropriate professional training of the head of a legal entity division located at a new address, in the implementation of narcotic drug trafficking and psychotropic substances, lists I - III list, precursors listed in the list I list, and cultivation of drug-containing plants .

9. If there is an intention to perform work (provide a service) for the cultivation of drug-containing plants, previously not specified in the license, the licensee is in a statement about the reformation of the license indicates this work (service), and also represents:

A) information about the new work (service) for the cultivation of drug-containing plants, which the licensee intends to perform (render);

b) copies of documents that confirm the presence of a license for the right of ownership or other legal framework of the relevant requirements and necessary for the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants of equipment, premises and land, rights to which are not registered in the Unified State Register of Rights to Real Estate and Transactions with Him (if such rights are registered in the specified register - information about these premises and land);

c) information on the presence of the conclusion of the body control of drug trafficking and psychotropic substances provided for by paragraph 3 of paragraph 3 of Article 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances".

10. When conducting an inspection of information contained in the license applicant (license) of the application and the documents attached to it, compliance with the license applicant (Licensee) licensed requirements, the licensing authority requests the information necessary for the licensing authorities providing public services, authorities providing municipal services , other state bodies, local governments or its subordinate organizations 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 "a single portal of state and municipal services (functions)" in the manner prescribed by the Government of the Russian Federation, information on the progress of the decision to provide or renew the license, to conduct a verification of the compliance of the license applicant and the licensee license provided for in paragraphs 4 and 5 of these Regulations.

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

b) adoption by the licensing authority of the decision on the provision, renewal, suspension, renewal, termination of the license;

C) obtaining from the federal tax service information on the liquidation of a legal entity or the termination of its activities as a result of the reorganization, on the termination of an individual as an individual entrepreneur;

d) entry into force of the court's decision to cancel the license.

13. Licensed control is carried out in the manner prescribed by the Federal Law "On the Protection of Rights of Legal Entities and Individual Entrepreneurs in the Implementation of State Control (Supervision) and Municipal Control", taking into account the characteristics of the organization and conduct of the inspections established by the Federal Law "On the licensing of certain types of activities" .

14. Submission of a license applicant Applications and documents necessary for obtaining a license, and their reception licensing authority, adopting a licensing authority to provide a license (on refusal to provide a license), reissuing a license (on refusal to reissuate the license), suspension, resumption, stopping, termination license actions, as well as the provision of duplicate and copies of the license, formation and maintenance of license case, maintaining the registry of licenses and the provision of information contained in the license registry are carried out in the manner prescribed by the Federal Law "On Licensing Special Activities".

When making a licensing authority, a decision on the provision of a license providing for the work and services specified in paragraphs 2, 3, 11, 15, 16, 23, 27, 28, 39, 43, 44, 55, 63 of the annex to this Regulation, in the license The names of specific narcotic drugs, psychotropic substances and (or) precursors in accordance with articles and federal law "On narcotic drugs and psychotropic substances" are indicated.

15. Maintaining a consolidated license registry, including licenses issued by the executive authorities of the constituent entities of the Russian Federation in accordance with the powers transferred, is carried out by the Federal Health Supervision Service.

(as amended by the Decree of the Government of the Russian Federation of 04.09.2012 N 882)

16. The executive authorities of the constituent entities of the Russian Federation monthly, up to the 10th, send data contained in the registers of licenses of the constituent entities of the Russian Federation to the Federal Health Supervision Service.

(as amended by the Decree of the Government of the Russian Federation of 04.09.2012 N 882)

17. For providing or re-issuing a licensing authority of the license, the issuance of a duplicate license on paper pays state duty in size and manner as established by the legislation of the Russian Federation on taxes and fees.

Annex to the Regulation

application
to the Regulations on Licensing
activity on the turnover of narcotic
funds, psychotropic substances
and their precursors, cultivation
drug-containing plants

The list of works and services that make up activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants

from 24.05.2012 N 507)

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

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

3. Production of analytical (standard) samples of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

4. Processing of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

5. Storage of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

6. Transportation of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

7. The sale of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

8. Vacation (with the exception of leave to individuals) of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

9. Distribution of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

10. Acquisition of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

11. The use of narcotic drugs and psychotropic substances listed in the list I list

12. The use of narcotic drugs and psychotropic substances listed in the list I list

13. Destruction of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

14. Development of new precursors of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

15. Production of precursors of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation in order to manufacture analytical (standard) samples.

16. Production of analytical (standard) samples of precursors of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

17. Processing of precursors of narcotic drugs and psychotropic substances listed in the list I of the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

18. Storage of precursors of narcotic drugs and psychotropic substances listed in the list I of the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

19. Transportation of precursors of narcotic drugs and psychotropic substances listed on the I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

20. Vacation (with the exception of leave to individuals) precursors of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

21. The implementation of precursors of narcotic drugs and psychotropic substances listed in the list I of the list of drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

22. Acquisition of precursors of narcotic drugs and psychotropic substances listed on the I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

23. The use of precursors of narcotic drugs and psychotropic substances listed on the I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, scientific and educational purposes.

24. The use of precursors of narcotic drugs and psychotropic substances listed in the list I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation in expert activities.

25. Destruction of precursors of narcotic drugs and psychotropic substances listed on the I list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

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

27. Production of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

28. Production of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

29. Processing of narcotic drugs and psychotropic substances listed in the list of the II list of drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

30. Storage of narcotic drugs and psychotropic substances listed in the list of drugs of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

31. Transportation of narcotic drugs and psychotropic substances listed in the list II of the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

32. Vacation to individuals of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

33. Vacation (with the exception of leave to individuals) of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

34. The sale of narcotic drugs and psychotropic substances listed on the list of drugs of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

35. The distribution of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

36. The acquisition of narcotic drugs and psychotropic substances listed in the list of the II list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

37. The use of narcotic drugs and psychotropic substances listed in List II List

38. The use of narcotic drugs and psychotropic substances listed in List II List

39. The use of narcotic drugs and psychotropic substances listed on the list of drugs of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation in scientific and educational purposes.

40. The use of narcotic drugs and psychotropic substances listed on the list of drugs of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation in expert activities.

41. Destruction of narcotic drugs and psychotropic substances listed in the list II of the list of drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

42. Development of new psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

43. Production of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

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

49. Vacation (with the exception of leave to individuals) of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

50. Implementation of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

51. The distribution of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

52. The acquisition of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

53. The use of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation for medical purposes.

54. The use of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation in veterinary medicine.

55. The use of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, in scientific and educational purposes.

56. The use of psychotropic substances listed in the list of the III list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, in expertise.

Narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

61. The implementation of precursors of narcotic drugs and psychotropic substances, included in Table I of the list of IV list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

62. The acquisition of precursors of narcotic drugs and psychotropic substances entered in Table I of the list of IV list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

63. The use of precursors of narcotic drugs and psychotropic substances entered in Table I of the list of IV list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation.

(as amended by the Decree of the Government of the Russian Federation of 24.05.2012 N 507)

64. Cultivation of drug-containing plants included in the list of plants containing narcotic drugs or psychotropic substances or their precursors and to be controlled in the Russian Federation for

3. Resolution of the Government of the Russian Federation of April 7, 2008 N 249 "On approval of the Regulations on the licensing of activities related to the turnover of narcotic drugs and psychotropic substances listed in the list I in accordance with the Federal Law" On Narcotic Drugs and Psychotropic Substances "(Assembly Legislation of the Russian Federation, 2008, N 15, Art. 1556).

4. Paragraph three of paragraph 1 Decree of the Government of the Russian Federation of June 12, 2008 N 449 "On the order of transportation of narcotic drugs, psychotropic substances and their precursors in the Russian Federation, as well as the design of the documents necessary for this" (Meeting of the 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 revolutions of narcotic drugs and psychotropic substances, approved by the Decree of the Government of the Russian Federation of December 31, 2009 N 1148 (Meeting of the Legislation of the Russian Federation, 2010, N 4, Art. 394 ).

6. Items and changes that are made to the acts of the Government of the Russian Federation on State Control (Supervision) approved by Decree of the Government of the Russian Federation of April 21, 2010 N 268 (Meeting of the legislation of the Russian Federation, 2010, N 19, Art. 2316).

7. Resolution of the Government of the Russian Federation of May 11, 2010 N 318 "On approval of the Regulation on the licensing of activities related to the production, processing, storage, implementation, acquisition and use of precursors of narcotic drugs and psychotropic substances entered in Table I list IV in accordance With federal law "On narcotic drugs and psychotropic substances" (Meeting of the legislation of the Russian Federation, 2010, N 20, Art. 2473).

Legislation of the Russian Federation, 2010, N 45, Art. 5863).

11. Paragraph third decree of the Government of the Russian Federation dated December 10, 2010 N 1012 "On licensing cultivation of plants containing narcotic drugs or psychotropic substances or their precursors for use in scientific, academic purposes and in expert activities" (meeting of the legislation of the Russian Federation, 2010, N 51, Art. 6943).

12. Paragraph 3 of the Decisions of the Government of the Russian Federation of July 20, 2011 N 599 "On measures of control in relation to drugs that contain small amounts of narcotic drugs, psychotropic substances and their precursors included in the list of drugs, psychotropic substances and their precursors subject to control in the Russian Federation "(Meeting of the legislation of the Russian Federation, 2011, N 30, Art. 4648).

The "Zakonbase" website presents a decree of the Government of the Russian Federation of 12/22/2011 N 1085 (ed. Dated 09/04/2012 with changes that have entered into force on September 18, 2012) "On licensing activities on the turnover of drugs, psychotropic substances and their precursors, cultivation of drug-containing Plants "in the most recent revision. Observe all the requirements of the legislation simply, if you familiarize yourself with the relevant sections, chapters and articles of this document for 2014. To search for the necessary legislation on the topic of interest, it is worth using convenient navigation or expanded search.

On the site "Zakonbase" you will find a decree of the Government of the Russian Federation of 12/22/2011 N 1085 (Ed. Dated 09/04/2012 with changes that have entered into force on September 18, 2012) "On licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation Drug-containing plants "in the fresh and full version, in which all changes and amendments are made. This ensures the relevance and accuracy of the information.

At the same time, the Decree of the Government of the Russian Federation dated December 22, 2011 No. 1085 (ed. From 09/04/2012 with changes that have entered into force on September 18, 2012) "On licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants" Completely for free, both completely and individual chapters.

The pharmacy should have 3 maximum licenses for implementation:

Pharmaceutical activity;

Activities associated with the turnover of NA and PV 2 list;

Activities associated with the turnover of PV 3 list.

Licensing This type of activity is carried out in the same way as a pharmaceutical activity, but the premises in which the NA and PV are stored separately.

This room should have permission of the organs of the Ministry of Internal Affairs of the Russian Federation, as well as tolerances for working with NA and PV to employees and order of the head of the pharmacy on persons with the right to work with the National Assembly and PV.

Licensing activities related to the turnover of NA and PV.

Licensing of NA and PV is carried out in accordance with FZ-3, which establishes the legal framework for state policies in the sphere of turnover of NA and PV and in the field of countering their illicit circulation in order to protect the health of citizens, state and public security.

Requirements for basic activities related to the turnover of NA and PV.

In the Russian Federation there is a state monopoly on the main activities related to the turnover of NA and PV (cultivation of plants, development, processing, distribution, destruction of NA and PV). The manufacture of NA and PV is carried out by state or municipal unitary enterprises. Violation of the state monopoly entails responsibility in accordance with the legislation of the Russian Federation.

FZ-3 establishes the following requirements and conditions:

The activities associated with the turnover of NA and PV can carry out a legal entity, which includes a specialist who has appropriate training (head of a pharmacy);

HDS should be provided for the conditions for ensuring the accounting and safety of NA and PV, as well as ensuring the safety of such activities (narcotic room; Security and fire alarm with an output on the remote control; Safes weighing less than 1 tons must be attached to the floor or wall; NA stock and PV monthly; on the windows of the lattice; two doors);

Yul can carry out this activity if there are following documents:

Certificate of a specialist, head of Yul or Head of the pharmacy or head of the relevant University of Yul;

Certificates issued by the agencies of the state or municipal system of the CSC, about the absence of workers who, by virtue of their official duties, will receive access directly to the NA and PV;

The conclusions of the state officers of the state officerocontrol about the absence of workers with an outstanding or unmanned criminal record for the crime of moderate gravity, a serious crime or a crime associated with the illicit trafficking of the NA.

Licensed requirements or conditions are:

The presence of premises on the right of ownership corresponding to sanitary and fire provisions and regulations;

The presence of material and technical equipment;

Compliance with technical reinforcement requirements;

Compliance with the rules of storage, accounting, vacation, destruction, use of NA and PV;

Compliance with the rules for storing the NA and PV, which have flammable and explosive properties;

Compliance with the requirements of persons admitted to work with NA and PV;

Availability in staff, pharmacists, pharmacists;

Having a 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 in tax authority;

Payment of state duty;

Certificates of specialists;

Copies of diplomas;

Certificates from psychiatric, narcological and organs of the Ministry of Internal Affairs;

Conclusion of the Ministry of Internal Affairs on the conformity of the established requirements for technical strengthening and equipping by the means of security alarm.

Topic 4. Labor Basics of Entrepreneurial Activities in Pharmacy

Lecture number 1. The concept of physical and legal entities. The main provisions of the Civil Code of the Russian Federation on individuals and legal entities. The procedure for registering a legal entity. Accuracy individual. Individual entrepreneurial activity. The order of registration of a legal entity and an individual entrepreneur. Commercial and non-commercial organizations.

Decree of the Government of the Russian Federation of December 22, 2011 N 1085
"On licensing activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants"

With changes and additions from:

a) Federal Health Supervision Service - in terms of implementation:

activities on the turnover of narcotic drugs and psychotropic substances entered in the lists I - III List implemented:

wholesale trade in medicines;

pharmaceutical organizations, subordinate to federal executive authorities;

other organizations and individual entrepreneurs in terms of licensed control (with the exception of licensees who submitted statements on reforming licenses), powers to suspend, resume action and cancellation of licenses;

List I list;

activities on the turnover of precursors of narcotic drugs and psychotropic substances entered in Table I list of the IV list;

activities for the cultivation of drug-containing plants;

Change information:

b) the executive authorities of the constituent entities of the Russian Federation - in terms of carrying out activities on the turnover of narcotic drugs and psychotropic substances listed in the lists I - III of the list (in terms of providing and re-issuing licenses, providing duplicates of licenses and copies of licenses, licensing control over license applicants and licensees that submitted statements on reforming licenses, termination of licenses, formation and maintenance of registers issued by state authorities of the constituent entities of the Russian Federation licenses, approval forms of applications for the provision and re-issuance of licenses, approval of notification forms, extracts from these registries of licenses and other licensing systems in the licensing process documents, as well as providing information to those interested in licensing information, including the placement of this information in the information and telecommunications network "Internet" on the official websites of state authorities Of the subjects of the Russian Federation, with an indication of email addresses, for which users of this information can be sent to requests and requested information received), carried out:

organizations, with the exception of the wholesale trade organizations of drugs and pharmacy organizations submitted by federal executive authorities;

paragraph has lost its strength from July 14, 2017 - Decree of the Government of the Russian Federation of July 4, 2017 N 791

premises and equipment necessary for the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants (with the exception of medical organizations and separate divisions of medical organizations located in rural settlements and remote from settlements localities in which there are no pharmacy organizations (hereinafter - medical organizations and separate units of medical organizations);

Change information:

Decree of the Government of the Russian Federation of August 6, 2015 N 807, paragraph 4 is supplemented by subparagraph "A.1"

a.1) the presence of a medical license to implement medical activities (if a license applicant is a medical organization);

b) compliance with the order of the decision

c) compliance with the license applicant with the intention to carry out activities on the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, precursors listed in the list I list, cultivation of drug-containing plants, articles 5 and

d) compliance with the license applicant with the intention to carry out activities on the turnover of precursors of narcotic drugs and psychotropic substances entered in Table I of the list of the IV list, paragraphs 5 - 7 and 11 of Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

a) the presence of ownership owned by him or other legitimate and relevant established requirements:

premises and equipment necessary for carrying out activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants (with the exception of medical organizations and separate units of medical organizations);

land registers required for cultivation of drug-containing plants;

Change information:

Decree of the Government of the Russian Federation of August 6, 2015 N 807 Item 5 supplemented with subparagraph "A.1"

a.1) Having a medical license for medical activities (if a licensee is a medical organization);

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

c) compliance with the licensee engaged in the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, precursors listed in the list I list, cultivation of drug-containing plants, the requirements of articles 5

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

e) compliance with the licensee carrying out the processing of narcotic drugs and psychotropic substances listed in the lists I - III of Article 19 of the Procedure for their processing established by the Decree of the Government of the Russian Federation of February 24, 2009 N 147;

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

h) compliance with a licensee carrying leave, the sale of narcotic drugs and psychotropic substances listed in the list I - III list, precursors listed in the list I list and the distribution of these narcotic drugs and psychotropic substances, the requirements of Article 23 of the Federal Law "On Narcotic Drugs and psychotropic substances "and the order of their distribution, vacation and implementation established by the Decree of the Government of the Russian Federation of July 26, 2010 N 558;

i) compliance with the licensee carrying out vacation of narcotic drugs and psychotropic substances listed in lists of the II and III list, according to recipes containing the appointment of narcotic drugs and psychotropic substances, the requirements of Articles 25 and the Federal Law "On Narcotic Drugs and Psychotropic Substances";

k) Compliance with a licensee carrying out the production of narcotic drugs, psychotropic substances and their precursors listed in the list I, in order to manufacture analytical (standard) samples and the manufacture of analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, requirements of Article 17 Federal law "On narcotic drugs and psychotropic substances";

p) Compliance with the licensee using narcotic drugs and psychotropic substances, listed in lists of the II and III of the List, in veterinary medicine, 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 the Decree of the Government of the Russian Federation from 3 September 2004 N 453;

(p) Compliance with the licensee using narcotic drugs and psychotropic substances made to the lists I - III list, the precursors listed on the list I and Table I of the list of the IV list, in scientific and academic purposes, as well as in expert activities, the requirements of articles 34 and the federal the law "On narcotic drugs and psychotropic substances";

(c) Compliance with the licensee engaged in the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, the requirements of Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the order of the decision

t) Compliance with the licensee engaged in the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, the requirements of Article 39 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the order of the Government of the Russian Federation of November 4, 2006 N 644 ;

(u) Compliance with a licensee carrying out activities on the turnover of narcotic drugs and psychotropic substances lists I - III List, rules for the development, production, manufacture, storage, transportation, shipments, vacation, implementation, distribution, acquisition, use, importation into the customs territory Of the Russian Federation, export from the customs territory of the Russian Federation, the destruction of tools and equipment under special control and used for the production and manufacture of narcotic drugs, psychotropic substances established by the Decree of the Government of the Russian Federation of March 22, 2001 N 221;

(f) Compliance with the licensee engaged in the turnover of precursors of narcotic drugs and psychotropic substances listed in List I and Table I of Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for submitting reports on activities related to their turnover established by the Resolution

h) the presence in the state of the licensee operating on the turnover of narcotic drugs and psychotropic substances listed in the lists I - III list, precursors listed in the list I list, workers who have a secondary professional, higher professional, additional vocational education and (or) special preparation in the sphere of narcotic drugs, psychotropic substances and their precursors, complying with the requirements and nature of the work performed;

w) Improving the qualifications of specialists with pharmaceutical and medical education operating on the turnover of narcotic drugs and psychotropic substances listed in the list I - III of the list, precursors listed in the list I of the list, at least once every 5 years.

7. To obtain a license, a license applicant sends or submits to the licensing authority a statement (in the performance of work (provision of services) provided for in paragraphs 2 ,,, Annexes to this Regulation, - indicating specific drugs and psychotropic substances entered in lists I - III list, and precursors listed in List I and Table I list IV list) and documents (copies of documents) specified in Part 1 and paragraphs 1, and 4 of Part 3 of Article 13 of the Federal Law " licensing of certain types of activities ", as well as:

a) copies of documents that confirm the availability of a license for the right of ownership or on the other legitimate basis of the relevant requirements and necessary for the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants of equipment, premises and land plots, rights to which are not registered in the unified state register of rights to immovable property and transactions with it (if such rights are registered in the specified registry - information about these premises and land plots) (with the exception of medical organizations and separate units of medical organizations);

Change information:

Decree of the Government of the Russian Federation of August 6, 2015 N 807 Paragraph 7 is supplemented by subparagraph "A.1"

a.1) Information about the availability of a license for medical activities (if the licensee is a medical organization);

c) copies of certificates issued by state or municipal healthcare facilities in the procedure established by the legislation of the Russian Federation, the absence of workers who, in accordance with their official duties, should have access to narcotic drugs, psychotropic substances, as well as precursors listed in List I and Table I list of IV list, or cultivated drug-containing plants, diseases of drug addiction, toxicomic, chronic alcoholism;

d) information on the presence of the conclusions of the body control of narcotic drugs and psychotropic substances provided for by paragraphs of the third and fifth paragraph 3 of Article 10 and paragraph of the third paragraph 7 of Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

Change information:

Decree of the Government of the Russian Federation of August 6, 2015 N 807 Paragraph 8 is supplemented by subparagraph "A.1"

a.1) Information on the availability of a license for medical activities with a new address of the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants (for medical organizations);

b) copies of documents that confirm the presence of a license for the right of ownership or other legal framework of the relevant requirements and necessary for the implementation of activities on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants of equipment, premises and land, rights to which are not registered in the unified state register of rights to immovable property and transactions with it (if such rights are registered in the specified registry - information about these premises and land plots) (with the exception of medical organizations and separate units of medical organizations);

paragraph 3 of paragraph 3 of Article 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";

d) information on the certificate of a specialist confirming the appropriate professional training of the head of a legal entity division located at a new address, in the implementation of narcotic drug trafficking and psychotropic substances, lists I - III list, precursors listed in the list I list, and cultivation of drug-containing plants .

a) information about the new work (service) for the cultivation of drug-containing plants, which the licensee intends to perform (render);

10. When conducting an inspection of information contained in the license applicant (license) of the application and the documents attached to it, compliance with the license applicant (Licensee) licensed requirements, the licensing authority requests the information necessary for the licensing authorities providing public services, authorities providing municipal services , other state bodies, local government bodies or its subordinate organizations in the manner prescribed by the Federal Law "On the organization of the provision of state and municipal services".