Legislative base of the Russian Federation. Legislative framework of the Russian Federation Order 1085 on the licensing of pharmaceutical activities
Chairman of the Government of the Russian Federation
Regulations on Licensing Activities in the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, Cultivation of Drug-Containing Plants
1. This Regulation establishes the procedure for licensing activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants, carried out by legal entities and individual entrepreneurs.
Licensing is subject to activities involving 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 the Decree of the Government of the Russian Federation of June 30, 1998 No. No. 681 (hereinafter - 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 drug-containing plants).
2. Activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants include works and services in accordance with the annex.
3. Licensing of activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants is carried out by the following licensing bodies.
other organizations and individual entrepreneurs in terms of licensing control (with the exception of licensees who have submitted applications for reissuing 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, the cultivation of narcotic plants" (together with the "Regulation 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 of December 22, 2011 N 1085 "On licensing activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants", establishing the Regulation on the licensing of activities for the circulation of narcotic drugs, psychotropic substances and their precursors, cultivation drug-containing plants, as well as a list of works and services that make up the specified activity (entered into force on January 10, 2012);
Active Edition from 04.09.2012
| Document name | Decree of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) "ON LICENSING OF ACTIVITIES IN TRAFFIC OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION OF NARCOSIDES" |
| Type of document | decree, regulation |
| Host body | Russian government |
| Document Number | 1085 |
| Acceptance date | 18.09.2012 |
| Revision date | 04.09.2012 |
| Date of registration in the Ministry of Justice | 01.01.1970 |
| Status | valid |
| Publication |
|
| Navigator | Notes |
Decree of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) "ON LICENSING OF ACTIVITIES IN TRAFFIC OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATION OF NARCOSIDES"
In accordance with the Federal Law "On Licensing Certain Types of Activities", the Government of the Russian Federation decides:
1. Approve the attached Regulations on Licensing Activities in the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, Cultivation of Drug-Containing Plants.
2. Recognize as invalid the acts of the Government of the Russian Federation in accordance with the appendix.
Prime Minister
Russian Federation
V. PUTIN
APPROVED
Government Decree
Russian Federation
dated December 22, 2011 N 1085
dated 05/24/2012 N 507, dated 09/04/2012 N 882)
1. This Regulation establishes the procedure for licensing activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants, carried out by legal entities and individual entrepreneurs.
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 the Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter - 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 in scientific, educational purposes and in expert activities (hereinafter referred to as the cultivation of drug-containing plants).
2. Activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants include works and services in accordance with the annex.
3. Licensing of activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants is carried out by the following licensing bodies:
a) The Federal Service for Surveillance in the Sphere of Healthcare - in terms of implementation:
(As amended by Decrees of the Government of the Russian Federation of 04.09.2012 N 882)
activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, carried out:
Organizations of wholesale trade in medicines;
from January 1, 2012 - pharmacy organizations subordinate to federal executive authorities, state academies of sciences;
activities for the circulation of precursors of narcotic drugs and psychotropic substances included in list I of the list;
activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the List;
Activities for 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 of 04.09.2012 N 882)
4. An applicant for a license to carry out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (hereinafter referred to as the license) must comply with the following licensing requirements:
dated August 6, 1998 N 892;
c) compliance by the license applicant, who intends to carry out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of precursors included in list I of the list, the cultivation of narcotic plants, articles and
D) compliance by the license applicant who intends to carry out activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the List, paragraphs - and Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";
e) the presence in the state of the license applicant who intends to carry out activities for 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 circulation of narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed.
5. The licensee, when carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, must comply with the following licensing requirements:
a) the presence of property belonging to him or on other legal grounds and corresponding to the established requirements:
premises and equipment necessary for the implementation of activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants;
land plots necessary for the 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 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, 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, who stores 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;
3) compliance by the licensee dispensing and selling narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the 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 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 and the Federal Law "On Narcotic Drugs and Psychotropic Substances";
J) compliance by the licensee, engaged in the production of narcotic drugs, psychotropic substances and their precursors, included in List I of the list, for the purpose of manufacturing analytical (standard) samples and the manufacture of analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, the requirements of Article 17 Federal Law "On Narcotic Drugs and Psychotropic Substances";
L) compliance by the licensee, engaged in the production and manufacture of narcotic drugs and psychotropic substances included in lists II and III of the list, with the requirements of articles and the Federal Law "On Narcotic Drugs and Psychotropic Substances";
l) compliance by the licensee engaged in the destruction of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, 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 for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the List, of the requirements of paragraphs - and 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 of the list 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 of the list 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 for expert activities, of the requirements of articles and the Federal Law "On narcotic drugs and psychotropic substances";
c) compliance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the requirements of Article 37 of November 4, 2006 N 644;
T) compliance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the requirements of Article 39 of November 4, 2006 N 644;
Y) observance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the 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 tools and equipment 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 for the circulation of precursors of narcotic drugs and psychotropic substances included in list I and table I of list IV of the list of 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 turnover established by Decree of the Government of the Russian Federation of June 9, 2010 N 419;
x) compliance by the licensee, engaged in the circulation of precursors of narcotic drugs and psychotropic substances included in list I and table I of list IV of the list, with the requirements of Article 39 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for maintaining and storing special transaction registers, related to their turnover, established by Decree of the Government of the Russian Federation of June 9, 2010 N 419;
v) observance by the licensee, carrying out activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the list, of the procedure for the production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances, established by the Government Decree Russian Federation dated August 18, 2010 N 640;
W) the presence in the state of a licensee carrying out activities for 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 circulation of narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed;
III) advanced training of specialists with pharmaceutical and medical education 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, at least once every 5 years.
6. Carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants in gross violation of license requirements entails liability established by the legislation of the Russian Federation.
In this case, a gross violation is understood as a failure by the licensee to comply with the requirements provided for in subparagraphs "a" - "p", "t" - "y", "x" and "c" of paragraph 5 of this Regulation, which entailed 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 shall send or submit 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 annexes to this Regulation - 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 Certain Types of Activities", as well as:
a) copies of documents that confirm that the applicant for a license on the right of ownership or on another legal basis meets the established requirements and is necessary for the implementation of activities in the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing 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 specified register - information about these premises and land plots);
b) a copy of a specialist certificate confirming the appropriate professional training of the head of the legal entity or the head of the relevant subdivision of the legal entity in the implementation of the circulation 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 drug-containing plants;
C) copies of certificates issued by state or municipal health care institutions in accordance with the procedure established by the legislation of the Russian Federation, stating 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 I of list IV of the list, or cultivated drug-containing plants, diseases of drug addiction, substance abuse, chronic alcoholism;
D) information on the availability of conclusions of the body 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 involved 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, as well as on the qualifications of pharmaceutical and medical workers.
8. If the licensee intends to carry out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants at an address not specified in the license, the licensee shall indicate this address in the application for renewal of the license, and also submit:
a) information containing a new address for carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants;
paragraph 3 of Article 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";
D) information about the certificate of a specialist, confirming the appropriate professional training of the head of the subdivision of a legal entity located at a new address, in the implementation of the circulation 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 the licensee intends to perform work (provide a service) on the cultivation of narcotic plants that was not previously specified in the license, the licensee shall indicate this work (service) in the application for renewal of the license, and also submit:
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 that the applicant for a license on the right of ownership or on another legal basis meets the established requirements and is necessary for carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing 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 specified register - information about these premises and land plots);
c) information about the presence of the conclusion of the body 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 the authorities providing public services, the authorities providing municipal services , other state bodies, bodies of local self-government 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 "Single 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 reissue a license, check the compliance of the license applicant and licensee with licensing requirements provided for in paragraphs 4 and 5 of these Regulations.
12. Information related to the implementation of activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, provided for in parts and articles 21 of the Federal Law "On Licensing Certain Types of Activities", is posted in the official electronic or print media of the licensing authority and (or) at information stands in the premises of the licensing authority within 10 days from the date of:
b) adoption by the licensing body of a decision on granting, reissuing, suspension, renewal, termination of the license;
C) receiving from the Federal Tax Service information on the liquidation of a legal entity or the termination of its activities as a result of reorganization, on the termination of an individual's activities as an individual entrepreneur;
d) the entry into force of the court decision on the annulment of 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 Certain Types of Activities" .
14. Submission by the license applicant of an application and documents required for obtaining a license, and their acceptance by the licensing authority, adoption by the licensing authority of a decision to grant a license (to refuse to issue a license), to reissue a license (to refuse to reissue a license), to suspend, resume, terminate the validity of a license, as well as the provision of a duplicate and a copy of a license, the formation and maintenance of a license file, the maintenance of a register of licenses and the provision of information contained in the register of licenses, are carried out in accordance with the procedure established by the Federal Law "On Licensing Certain Types of Activities".
When the licensing authority decides 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 annex to this Regulation, in the license the names of specific narcotic drugs, psychotropic substances and (or) precursors are indicated in accordance with articles and the Federal Law "On Narcotic Drugs and Psychotropic Substances".
15. Maintaining a consolidated register of licenses, including licenses issued by the executive authorities of the constituent entities of the Russian Federation in accordance with the transferred powers, is carried out by the Federal Service for Surveillance in Healthcare.
(As amended by Decrees 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, before the 10th day, 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.
(As amended by Decrees of the Government of the Russian Federation of 04.09.2012 N 882)
17. For the granting or re-issuance of a license by the licensing authority, the issuance of a duplicate license on paper, a state fee is paid in the amount and procedure established by the legislation of the Russian Federation on taxes and fees.
Appendix TO THE REGULATIONApplication
to the Licensing Regulations
drug trafficking activities
drugs, psychotropic substances
and their precursors, cultivation
drug-containing plants
dated 24.05.2012 N 507)
1. Development of new narcotic drugs and psychotropic substances included in list I of the list
2. Manufacture 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. Sale 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 (with the exception of 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. Acquisition 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 manufacturing 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 (with the exception of 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. Sale 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. Acquisition 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. 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. 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.
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 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.
33. Dispensing (with the exception of 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. Sale 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. Acquisition 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. 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. 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. Manufacture 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.
the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.
49. Dispensing (with the exception of dispensing to individuals) 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. Sale 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. Acquisition 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. 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 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. 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. 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. Sale 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. Acquisition 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.
63. Use 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 of 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" (Collection legislation of the Russian Federation, 2008, N 15, item 1556). 4. Paragraph three of clause 1 of Decree of the Government of the Russian Federation of June 12, 2008 N 449 "On the procedure for the transportation of narcotic drugs, psychotropic substances and their precursors on the territory of the Russian Federation, as well as the execution of the documents necessary for this" (Collected Legislation of the Russian Federation, 2008 , N 25, item 2982). 5. Clauses 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. Clauses and changes that are made to the acts of the Government of the Russian Federation on issues of state control (supervision), approved by the Decree of the Government of the Russian Federation of April 21, 2010 N 268 (Sobranie zakonodatelstva Rossiyskoy Federatsii, 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, purchase and use of precursors of narcotic drugs and psychotropic substances listed in Table I of List IV in accordance with the Federal Law "On Narcotic Drugs and Psychotropic Substances" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2010, N 20, Art. 2473).
11. Paragraph three of 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 in scientific, educational purposes and in expert activities" (Collected Legislation of the Russian Federation, 2010, N 51, item 6943).
12. Clause 3 of Decree of the Government of the Russian Federation of July 20, 2011 N 599 "On control measures in relation to drugs that contain small amounts 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" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2011, N 30, art. 4648).
The website "Zakonbase" presents the DECISION of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) "ON LICENSING ACTIVITIES IN TRAFFIC OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTURES PLANTS" in the latest edition. It is easy to comply with all legal requirements if you familiarize yourself with the relevant sections, chapters and articles of this document for 2014. To search for the necessary legislative acts on a topic of interest, you should use convenient navigation or advanced search.
On the website "Zakonbase" you will find the DECISION of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) "ON LICENSING ACTIVITIES IN TRAFFIC OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTURE 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, you can download the DECISION of the Government of the Russian Federation of December 22, 2011 N 1085 (as amended on September 4, 2012 with amendments that entered into force on September 18, 2012) "ON LICENSING ACTIVITIES IN TRAFFIC OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND THEIR PRECURSORS, CULTIVATED DRUGS" completely free, both completely and in separate chapters.
A pharmacy must have 3 maximum licenses for the implementation of:
Pharmaceutical activity;
Activities related to the turnover of NA and PV 2 of the List;
Activities related to the turnover of PV 3 of the List.
Licensing for this type of activity is carried out in the same way as for pharmaceutical activities, but the premises in which the NA and HP are stored are separately licensed.
This room must have permission from the Ministry of Internal Affairs of the Russian Federation, as well as permits for working with NA and PV for employees and an order from the head of the pharmacy for persons entitled to work with NA and PV.
Licensing of activities related to the turnover of NA and PV.
Licensing of NA and HP is carried out in accordance with the Federal Law-3, which establishes the legal framework for state policy in the field of circulation of NA and HP and in the field of countering their illegal circulation in order to protect the health of citizens, state and public security.
Requirements for the main types of activities related to the turnover of NA and PV.
In the Russian Federation, there is a state monopoly on the main types of activities related to the turnover of NS and HP (cultivation of plants, development, processing, distribution, destruction of NS and HP). The manufacture of NS and PV is carried out by state or municipal unitary enterprises. Violation of the state monopoly entails liability in accordance with the legislation of the Russian Federation.
FZ-3 establishes the following requirements and conditions:
Activities related to the turnover of NA and PV can be carried out by a legal entity, whose leaders include a specialist with appropriate professional training (head of a pharmacy);
Legal entities must provide conditions for ensuring the accounting and safety of NA and PE, as well as ensuring the safety of such activities (drug room; security and fire alarm with output to the remote control of private security; safes weighing less than 1 ton must be attached to the floor or wall; stock of NA and PV monthly; bars on the windows; two doors);
A legal entity can carry out this activity if the following documents are available:
Certificate of a specialist, head of a legal entity or head of a pharmacy or head of the relevant division of a legal entity;
Certificates issued by institutions of the state or municipal system of ZO, on the absence of employees who, by virtue of their official duties, will have access directly to the NS and PV;
Conclusions of the Gosnarkokontrol bodies on the absence of outstanding or unexpunged convictions for crimes of medium gravity, a serious crime or a crime related to the illegal circulation of NA among employees.
The license requirements or conditions are:
Availability of premises on the right of ownership, corresponding to sanitary, fire-prevention norms and rules;
Availability of material and technical equipment;
Compliance with the requirements for technical strength;
Compliance with the rules of storage, accounting, release, destruction, use of NS and PV;
Compliance with the rules for storage of NS and HP, which have flammable and explosive properties;
Compliance with the requirements by persons admitted to work with the NS and HP;
The presence in the staff of workers, pharmacists, pharmacists;
The presence of the head of the legal entity 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;
Specialist certificates;
Copies of diplomas;
Certificates from psychiatric, narcological and Ministry of Internal Affairs bodies;
Conclusion of the Ministry of Internal Affairs on compliance with the established requirements for technical strength and equipment with security alarms.
TOPIC 4. LEGISLATIVE BASIS FOR BUSINESS ACTIVITIES IN PHARMACY
Lecture number 1. The concept of individuals and legal entities. Basic provisions of the Civil Code of the Russian Federation on individuals and legal entities. The procedure for registering a legal entity. Legal capacity of an individual. Individual entrepreneurial activity. The procedure for registering a legal entity and an individual entrepreneur. Commercial and non-profit organizations.
Decree of the Government of the Russian Federation of December 22, 2011 N 1085
"On Licensing Activities for the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, Cultivation of Drug-Containing Plants"
With changes and additions from:
a) The Federal Service for Surveillance in the Sphere of Healthcare - in terms of implementation:
activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, carried out:
organizations of wholesale trade in medicines;
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 reissuing licenses), powers to suspend, renew and cancel licenses;
list I of the list;
activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the List;
activities for the cultivation of drug-containing plants;
Information about changes:
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 (in terms of granting and reissuing licenses, providing duplicate licenses and copies of licenses, exercising license control in relation to license applicants and licensees who submitted applications for reissuing licenses, terminating licenses, creating and maintaining registers of licenses issued by state authorities of the constituent entities of the Russian Federation, approving forms of applications for granting and reissuing licenses, approving notification forms, extracts from the indicated registers of licenses and other licenses 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 state authorities subjects of the Russian Federation, indicating the e-mail addresses to which users of this information can send requests and receive the requested information), carried out by:
organizations, with the exception of wholesale trade organizations for medicines and pharmacy organizations subordinate to federal executive bodies;
the paragraph became invalid on July 14, 2017 - Decree of the Government of the Russian Federation of July 4, 2017 N 791
4. An applicant for a license to carry out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (hereinafter referred to as the license) must comply with the following licensing requirements:
premises and equipment necessary for the implementation of activities for 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 located in rural settlements and areas remote from settlements in which there are no pharmacy organizations (hereinafter - medical organizations and separate divisions of medical organizations);
Information about changes:
By Decree of the Government of the Russian Federation of August 6, 2015 N 807, paragraph 4 was supplemented with subparagraph "a.1"
a.1) the medical organization has a license to carry out medical activities (if the applicant for a license is a medical organization);
b) observance of the order by the decree
c) compliance by the license applicant who intends to carry 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, the cultivation of narcotic plants, articles 5 and
d) compliance by the license applicant who intends to carry out activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the list, paragraphs 5 - 7 and 11 of Article 30 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";
e) the presence in the state of the license applicant who intends to carry out activities for 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 circulation of narcotic drugs, psychotropic substances and their precursors, corresponding to the requirements and nature of the work performed.
5. The licensee, when carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants, must comply with the following licensing requirements:
a) the presence of property belonging to him or on other legal grounds and corresponding to the established requirements:
premises and equipment necessary for the implementation of activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants (with the exception of medical organizations and separate divisions of medical organizations);
land plots necessary for the cultivation of drug-containing plants;
Information about changes:
By Decree of the Government of the Russian Federation of August 6, 2015 N 807, paragraph 5 was supplemented with subparagraph "a.1"
a.1) the medical organization has a license to carry out medical activities (if the 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 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, the precursors included in list I of the list, the cultivation of narcotic plants, the requirements of Articles 5
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 Article 19 with 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 a 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 documents necessary for this, established by the Decree of the Government of the Russian Federation of June 12, 2008 N 449;
h) compliance by the licensee dispensing and selling narcotic drugs and psychotropic substances included in lists I-III of the list, precursors included in list I of the 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 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 the Federal Law "On Narcotic Drugs and Psychotropic Substances";
j) compliance by the licensee, engaged in the production of narcotic drugs, psychotropic substances and their precursors, included in List I of the List, for the purpose of manufacturing analytical (standard) samples and the manufacture of analytical (standard) samples of these narcotic drugs, psychotropic substances and their precursors, the requirements of Article 17 Federal Law "On Narcotic Drugs and Psychotropic Substances";
l) compliance by the licensee engaged in the destruction of narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, the requirements of Article 29 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for their destruction established by a Government decree Russian Federation dated June 18, 1999 N 647;
n) compliance by the licensee using narcotic drugs and psychotropic substances included in lists II and III of the list for medical purposes with the requirements of Article 31 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 of the list 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 for expert activities, of the requirements of Articles 34 and the Federal Law "On Narcotic Drugs and Psychotropic Substances";
c) compliance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the requirements of Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure by resolution
r) compliance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the requirements of Article 39 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure by Decree of the Government of the Russian Federation of November 4, 2006 N 644 ;
s) observance by the licensee, carrying out activities for the circulation of narcotic drugs and psychotropic substances included in lists I - III of the list, of the rules for the development, production, manufacture, storage, transportation, shipment, release, sale, distribution, acquisition, use, import into the customs territory the Russian Federation, the 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 Decree of the Government of the Russian Federation of March 22, 2001 N 221;
t) observance 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 Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for submitting reports on activities related to their circulation, established by the resolution
u) 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 the list of the requirements of Article 39 of the Federal Law "On Narcotic Drugs and Psychotropic Substances" and the procedure for maintaining and storing special transaction registers, related to their turnover, established by Decree of the Government of the Russian Federation of June 9, 2010 N 419;
v) observance by the licensee, carrying out activities for the circulation of precursors of narcotic drugs and psychotropic substances included in Table I of List IV of the list, of the procedure for the production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances, established by a Government decree Russian Federation dated August 18, 2010 N 640;
w) the presence in the state of a licensee carrying out activities for 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 circulation of 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 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, at least once every 5 years.
6. Carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants in gross violation of license requirements entails liability established by the legislation of the Russian Federation.
In this case, a gross violation is understood as a failure by the licensee to comply with the requirements provided for in subparagraphs "a" - "p", "t" - "y", "x" and "c" of paragraph 5 of this Regulation, which entailed 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 shall send or submit to the licensing authority an application (when performing work (rendering services) provided for in paragraphs 2, , , , , , , , , , , , of the annex to this Regulation, - indicating specific 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 and 4 of 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 for a license on the right of ownership or on another legal basis meets the established requirements and is necessary for the implementation of activities in the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants, equipment, premises and land plots, the right to who are not registered in the Unified State Register of Rights to Real Estate and Transactions with It (if such rights are registered in the specified register - information about these premises and land plots) (with the exception of medical organizations and separate divisions of medical organizations);
Information about changes:
By Decree of the Government of the Russian Federation of August 6, 2015 N 807, paragraph 7 was supplemented with subparagraph "a.1"
a.1) information on the availability of a license to carry out medical activities (if the licensee is a medical organization);
b) a copy of a specialist certificate confirming the appropriate professional training of the head of the legal entity or the head of the relevant subdivision of the legal entity 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, and the cultivation of narcotic plants;
c) copies of certificates issued by state or municipal health care institutions in accordance with the procedure established by the legislation of the Russian Federation, stating 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 I of list IV of the list, or cultivated drug-containing plants, diseases of drug addiction, substance abuse, chronic alcoholism;
d) information on the availability of conclusions of the body 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 involved 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, as well as on the qualifications of pharmaceutical and medical workers.
8. If the licensee intends to carry out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants at an address not specified in the license, the licensee shall indicate this address in the application for renewal of the license, and also submit:
Information about changes:
By Decree of the Government of the Russian Federation of August 6, 2015 N 807, paragraph 8 was supplemented with subparagraph "a.1"
a.1) information on the availability of a license to carry out medical activities, indicating a new address for carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (for medical organizations);
b) copies of documents that confirm that the applicant for a license on the right of ownership or on another legal basis meets the established requirements and is necessary for carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing plants, equipment, premises and land plots, the right to who are not registered in the Unified State Register of Rights to Real Estate and Transactions with It (if such rights are registered in the specified register - information about these premises and land plots) (with the exception of medical organizations and separate divisions of medical organizations);
paragraph 3 of clause 3 of Article 10 of the Federal Law "On Narcotic Drugs and Psychotropic Substances";
d) information about the certificate of a specialist confirming the appropriate professional training of the head of a subdivision of a legal entity located at a new address in the course of trafficking in narcotic drugs and psychotropic substances included in lists I - III of the list, precursors included in list I of the list, and cultivation of narcotic plants .
9. If the licensee intends to perform work (provide a service) on the cultivation of narcotic plants that was not previously specified in the license, the licensee shall indicate this work (service) in the application for renewal of the license, and also submit:
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 that the applicant for a license on the right of ownership or on another legal basis meets the established requirements and is necessary for carrying out activities for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of drug-containing 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 specified register - information about these premises and land plots);
c) information about the presence of the conclusion of the body 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 the authorities providing public services, the authorities providing municipal services , other state bodies, bodies of local self-government 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 "Single 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 reissue a license, check the compliance of the license applicant and licensee with licensing requirements provided for