Government Decree 644 on the procedure for granting. About the company and products
quarterly reports on the number of produced drugs and psychotropic substances - no later than May 15, August 15, November 15, February 15 of the year;
annual report on the number of produced, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their production for the year following the current year - annually, no later than February 15 (under the current one follows understand the year in which the accounts are submitted).
Information about changes:
Rules supplemented by paragraph 3.1 from July 7, 2018 - Decree
3.1. Legal entities engaged in the established procedure for the production of substances under international control, not included in the list, submit annually, no later than February 15, to the Ministry of Industry and Trade Russian Federation in the form according to Appendix N 1.1:
an annual report on the number of produced substances under international control that are not included in the list;
information on stocks of substances under international control, not included in the list, as of December 31 of the reporting year and the plan for their production for the year following the current year.
4. Legal entities engaged in the established procedure for the manufacture, dispensing and sale of narcotic drugs and psychotropic substances, with the exception of pharmacy organizations, medical organizations with pharmacy organizations, medical organizations located in rural areas settlements and remote areas from settlements in which there are no pharmacy organizations, and medical organizations with separate subdivisions located in rural and remote settlements in which there are no pharmacy organizations, submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix N 2:
quarterly reports on the number of manufactured narcotic drugs and psychotropic substances - no later than May 15, August 15, November 15, February 15 of the year;
an annual report on the quantity of manufactured, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their manufacture for the year following the current year - annually, no later than February 15.
Copies of the reports are sent within the specified time to the Ministry of Internal Affairs of the Russian Federation.
5. Legal entities that, in accordance with the established procedure, manufacture medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3:
an annual report on the quantity of narcotic drugs and psychotropic substances used for the production of medicinal products not included in the list, containing a small amount of narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their use for the production of medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances for the year following the current year.
Information about changes:
The rules were supplemented by clause 5.1 from July 7, 2018 - Decree of the Government of Russia of June 26, 2018 N 732
5.1. Legal entities engaged in the established procedure for the production of medicinal products containing substances under international control, not included in the list, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3.1:
an annual report on the number of substances under international control, not included in the list, used for the manufacture of medicines;
information on the stocks of substances under international control, not included in the list, as of December 31 of the reporting year and the planned volume of their use for the production of medicines for the year following the current year.
6. Legal entities that, in accordance with the established procedure, dispense and sell narcotic drugs and psychotropic substances through wholesale trade organizations submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 4:
an annual report on the number of dispensed and sold narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their release and sale for the year following the current year.
Copies of the reports are sent within the specified time to the relevant territorial bodies of the Ministry of Internal Affairs of the Russian Federation.
7. Legal entities importing narcotic drugs and psychotropic substances into the customs territory (export from the customs territory) of the Russian Federation in accordance with the established procedure shall submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the number of imported (exported) narcotic drugs and psychotropic substances no later than On the 10th day of the month following the reporting period, in the form in accordance with Appendix No. 5.
Information about changes:
The rules were supplemented by clause 7.1 from July 7, 2018 - Decree of the Government of Russia of June 26, 2018 N 732
7.1. Legal entities that, in accordance with the established procedure, import into the customs territory (export from the customs territory) of the Russian Federation of substances under international control that are not included in the list, submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the number of imported (exported) substances that are under international control, not included in the list, no later than the 20th day of the month following the reporting period, in the form in accordance with Appendix No. 5.1.
8. Pharmacy organizations, medical organizations with pharmacy organizations, medical organizations located in rural settlements and areas remote from settlements in which there are no pharmacy organizations, and medical organizations with separate subdivisions located in rural and remote settlements, in which there are no pharmacy organizations engaged in the established procedure for the manufacture of medicines containing narcotic drugs and psychotropic substances, the release and sale of narcotic drugs and psychotropic substances, are annually, no later than February 15, to the relevant territorial bodies of the Ministry of Internal Affairs of the Russian Federation in the form according to Appendix N 6 :
an annual report on the number of manufactured, dispensed and sold narcotic drugs and psychotropic substances;
9. Legal entities that, in accordance with the established procedure, use narcotic drugs and psychotropic substances in medical, veterinary, scientific and educational purposes, when conducting examinations with their use or for their identification, submit annually, no later than February 15, to the relevant territorial bodies of the Ministry of Internal Affairs of the Russian Federation in the form in accordance with Appendix No. 7:
an annual report on the amount of narcotic drugs and psychotropic substances used;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year.
10. The legal entities specified in paragraphs 3 and these Rules shall attach to their annual reports information on the number of narcotic drugs and psychotropic substances destroyed in accordance with the established procedure.
15. In case of reorganization or liquidation of a legal entity, reports on its activities for the period not included in the last reports submitted before the day of reorganization or liquidation (including information on reserves on the day of reorganization or liquidation) are submitted in the following order:
in case of reorganization - by a legal entity or its successor (successors) in accordance with the deed of transfer or separation balance sheet;
in case of liquidation - by a legal entity or a liquidation commission not late afternoon following the day of its exclusion from the Unified State Register of Legal Entities.
16. The Ministry of Industry and Trade of the Russian Federation, on the basis of reports received in accordance with paragraphs 3 - 6 of these Rules, draws up consolidated quarterly reports no later than June 15, September 15, December 15, March 15 of the year and annual reports no later than March 15 of the year forms in accordance with Annexes No. 1 - 4 and submit them to the Ministry of Internal Affairs of the Russian Federation.
17. The Ministry of Industry and Trade of the Russian Federation, on the basis of the reports received in accordance with paragraphs 7 and 7.1 of these Rules, draws up consolidated quarterly reports and submits them to the Ministry of Internal Affairs of the Russian Federation:
no later than the 20th day of the month following the reporting period - in the form in accordance with Appendix No. 5;
no later than May 25, August 25, November 25 and February 25 - in the form in accordance with Appendix N 5.1.
The reports provide data for each legal entity.
Copies of the reports are sent within the specified time to the Ministry of Health of the Russian Federation.
18. The Ministry of Health of the Russian Federation, taking into account the consolidated reports received in accordance with paragraphs 16 and these Rules, determines for the year following the current year the need of the Russian Federation for narcotic drugs and psychotropic substances, as well as substances under international control, not included in the list.
Information on the need for narcotic drugs and psychotropic substances for the next year is submitted to the Ministry of Internal Affairs of the Russian Federation no later than May 31 of the current year in the form in accordance with Appendix No. 11.
Information on the need for substances under international control that are not included in the list for the next year is submitted to the Ministry of Internal Affairs of the Russian Federation no later than May 31 of the current year in the form in accordance with Appendix No. 13.
GOVERNMENT OF THE RUSSIAN FEDERATION
RESOLUTION
ON THE PROCEDURE FOR SUBMISSION OF INFORMATION
ON ACTIVITIES RELATED TO THE TRAFFIC OF NARCOTIC DRUGS
AND PSYCHOTROPIC SUBSTANCES AND REGISTRATION OF OPERATIONS RELATED
WITH PSYCHOTROPIC SUBSTANCES
List of changing documents
N 917,
In order to ensure state control for turnover in accordance with the Federal Law "On Narcotic Drugs and Psychotropic Substances", as well as the fulfillment of international obligations arising from the United Nations conventions to which the Russian Federation is a party, the Government of the Russian Federation decides:
REPORTING BY LEGAL ENTITIES
ON ACTIVITIES RELATED TO THE TRAFFIC OF NARCOTIC
DRUGS AND PSYCHOTROPIC SUBSTANCES
List of changing documents
(as amended by Decrees of the Government of the Russian Federation of 08.12.2008 N 917,
1. These Rules in accordance with Article 37 federal law"On Narcotic Drugs and Psychotropic Substances" establishes the order of submission:
reports on activities related to the circulation of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, item 3198; 2006, N 29, item 3253) (hereinafter - narcotic drugs and psychotropic substances), and information about their stocks as of December 31 of the reporting year;
(as amended by Decrees of the Government of the Russian Federation of December 8, 2008 N 917, of August 6, 2015 N 807)
quarterly reports on the number of manufactured narcotic drugs and psychotropic substances - no later than May 15, August 15, November 15, February 15 of the year;
an annual report on the quantity of manufactured, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their manufacture for the year following the current year - annually, no later than February 15.
Copies of the reports are sent within the specified time to the Federal Drug Control Service of the Russian Federation.
5. Legal entities that, in accordance with the established procedure, manufacture medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3:
an annual report on the amount of narcotic drugs and psychotropic substances used;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year.
10. The legal entities specified in paragraphs 3 and these Rules shall attach to their annual reports information on the number of narcotic drugs and psychotropic substances destroyed in accordance with the established procedure.
Copies of the reports are sent within the specified time to the Ministry of Health of the Russian Federation.
(as amended by Decrees of the Government of the Russian Federation of 08.12.2008 N 917, of 04.09.2012 N 882)
18. The Ministry of Health of the Russian Federation, taking into account the consolidated reports received in accordance with paragraphs 16 and these Rules, determines for the year following the current year the need of the Russian Federation for narcotic drugs and psychotropic substances.
(As amended by Decrees of the Government of the Russian Federation of 04.09.2012 N 882, of 04.02.2013 N 78)
Information on the need for narcotic drugs and psychotropic substances for the next year is submitted to the Federal Drug Control Service of the Russian Federation no later than May 31 of the current year in the form in accordance with Appendix No. 11. The information is accompanied by a description of the method used to determine the need for them, as well as information on the number of doctors and dentists practicing in the Russian Federation, the number of pharmacies, medical institutions and hospital beds.
on the production, release and sale
narcotic drugs and psychotropic substances
for _______________ 20__
Form N 1-P
quarterly, annual
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name │Produced │Dispatched │Stock by │Plan
narcotic │for reporting │and real- │state │production
│ │period │ year │
1 │ 2 │ 3 │ 4 │ 5
─────────────────┼────────────┼─────────┼──────────┼──────────────
Supervisor
(surname, initials) (signature)
Executive,
responsible
initials)
(number (date of compilation
phone) report)
Appendix No. 2
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
on the manufacture, release and sale
narcotic drugs and psychotropic substances
for _______________ 20__
Form N 1-I
quarterly, annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, address Email)
License _________________________________________________________
(number, expiration date)
(grams)
─────────────────┬────────────┬─────────┬──────────┬──────────────
Name │Manufactured │Dispatched │Stock by │Plan
narcotic │for reporting │and real- │condition │manufacturing
funds, │ period │ called │ for 31 │ for a year,
psychotropic │ │per report-│ December │next to
substances │ │ ne- │ reporting │ current year
│ │period │ year │
─────────────────┼────────────┼─────────┼──────────┼──────────────
1 │ 2 │ 3 │ 4 │ 5
─────────────────┼────────────┼─────────┼──────────┼──────────────
─────────────────┴────────────┴─────────┴──────────┴──────────────
Supervisor
legal entity _____________________ _____________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ____________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 3
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
and psychotropic substances for the production
medicines not included in the list,
Form N 1-IMS
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name │Used │ Stock by │ Planned volume
narcotic │for production- │condition │ use for
funds, │stvo for from- │ by 31 │ production by
psychotropic │ even period │ December │ year following
substances │ │ reporting │ current year
│ │ years │
1 │ 2 │ 3 │ 4
─────────────────┼──────────────┼──────────┼──────────────────────
Supervisor
(surname, initials) (signature)
Executive,
responsible
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 4
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
on the sale and sale of narcotic drugs
and psychotropic substances for 20__
Form N 1-OP
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
─────────────────┬──────────────┬──────────┬──────────────────────
Name │ Released and │ Stock for │ Planned volume
narcotic │ sold │ state │ release and sale
funds, │ for the reporting │ by 31 │ for the next year
psychotropic │ period │ December │ for the current year
substances │ │ reporting │
│ │ years │
─────────────────┼──────────────┼──────────┼──────────────────────
1 │ 2 │ 3 │ 4
─────────────────┼──────────────┼──────────┼──────────────────────
─────────────────┴──────────────┴──────────┴──────────────────────
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 5
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
on the import (export) of narcotic drugs
and psychotropic substances
for ___________ 20__
(quarter)
Form N 1-BB
quarterly
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
(kilograms)
──────────────┬─────────────┬─────────────┬──────────────────────────┬────────────────────────────
License for │Name │ Quantity, │Imported during the reporting period│Exported during the reporting period
import (export) │drug-│ indicated in ───┬───────────────────────────────
(number, term of the │th means, │ license │if- │state-│base- │if- │state-│base
actions) │psychotropic│ │quality │stvo │nie (GTD)│quality│stvo │ (GTD)
│substances │ │ │ │ │ │ │
1 │ 2 │ 3 │ 4 │ 5 │ 6 │ 7 │ 8 │ 9
──────────────┼─────────────┼─────────────┼───────┼────────┼─────────┼──────┼────────┼────────────
│ │ │ │ │ │ │ │
──────────────┴─────────────┴─────────────┴───────┴────────┴─────────┴──────┴────────┴────────────
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 6
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
on the manufacture of medicines,
substances, release and sale of narcotic drugs
and psychotropic substances
Form N 1-ORAU
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
─────────────────┬─────────────┬──────────────────────┬───────────
Name │ Manufactured │ Issued and sold │ Stock by
drug │ for the reporting │ for the reporting period │ state
funds, │ period │ │ on 31
psychotropic │ │ │ December
substances │ │ │ reporting
│ │ │ years
1 │ 2 │ 3 │ 4
─────────────────┼─────────────┼──────────────────────┼───────────
─────────────────┴─────────────┴──────────────────────┴───────────
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 7
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
about the use of drugs
and psychotropic substances
Form N 1-ISP
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
───────────────────┬─────────────────┬────────────────────────────
Name │ Used │ Stock by condition
funds, │ period │ year
psychotropic │ │
substances │ │
───────────────────┼─────────────────┼────────────────────────────
───────────────────┴─────────────────┴────────────────────────────
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
Appendix No. 8
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
on the production of substances that are
under international control, not included in the list,
KEEPING AND STORING SPECIAL REGISTRATION LOGS
OPERATIONS RELATED TO THE TRAFFIC OF NARCOTIC DRUGS
AND PSYCHOTROPIC SUBSTANCES
List of changing documents
(as amended by Decrees of the Government of the Russian Federation of 06/09/2010 N 419,
11. The numbering of entries in the registers for each name of a narcotic drug or psychotropic substance is carried out within a calendar year in ascending order of numbers. The numbering of entries in new logbooks starts from the number following the last number in the completed logbooks.
19. In case of reorganization or liquidation of a legal entity, registration logs and documents confirming the implementation of operations related to the circulation of narcotic drugs and psychotropic substances shall be deposited:
narcotic drugs and psychotropic substances
__________________________________________________________________
Narcotic drug (psychotropic substance) ___________________
__________________________________________________________________
(name, dosage, release form, unit of measure)
──────┬───────┬──────────────────────────────────────┬──────┬────────────────────────────────────┬───────┬───────┬────────
month │ balance │ income │ total │ expense │ balance │ actual │ mark
│on the 1st ─┬────────┬──────┬──────────┬───────┤ on │chesky │ob in-
│ number │ date
.
│ │ │N and date │ │signature │ │ │ │and date │ │signature │ │ │ │
│ │ │income│ │answer- │ │ │ │expense- │ │response- │ │ │ │
│ │ │ document │ │ │ │ │ │ pre-│ │
│ │ │ │ │face │ │ │ │document │ │face │ │ │ │
1 │ 2 │ 3 │ 4 │ 5 │ 6 │ 7 │ 8 │ 9 │ 10 │ 11 │ 12 │ 13 │ 14 │ 15 │ 16
──────┼───────┼────┼──────────┼──────┼─────────┼─────┼──────┼────┼────────┼──────┼─────────┼─────┼───────┼───────┼────────
│ │ │ │ │ │ │ │ │ │ │ │ │ │ │
──────┴───────┴────┴──────────┴──────┴─────────┴─────┴──────┴────┴────────┴──────┴─────────┴─────┴───────┴───────┴────────
Appendix No. 2
to the Rules for maintaining and storing
special registers
operations related to turnover
narcotic drugs, psychotropic
substances and their precursors
registration of transactions related to the turnover
drug precursors
and psychotropic substances
Repealed from July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
Decree of the Government of the Russian Federation of November 4, 2006 N 644 (as amended on June 26, 2018) "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to the circulation of narcotic drugs and psychotropic substances" (together with "Rules for the submission by legal entities of reports on activities related to the circulation of narcotic drugs and psychotropic substances", "Rules for the maintenance and storage of special logs for registering operations related to the circulation of narcotic drugs and psychotropic substances")
- Rules for the submission by legal entities of reports on activities related to the circulation of narcotic drugs and psychotropic substances
- Appendix N 1. Report on the production, distribution and sale of narcotic drugs and psychotropic substances (Form N 1-P (quarterly, annual))
- Annex No. 1(1). Report on the production of substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list (Form N 2-P (annual))
- Appendix N 2. Report on the manufacture, sale and sale of narcotic drugs and psychotropic substances (Form N 1-I (quarterly, annual))
- Appendix N 3. Report on the use of narcotic drugs and psychotropic substances for the production of medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances (Form N 1-IMS (annual))
- Annex No. 3(1). Report on the production of medicinal products containing substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list (Form N 2-PLS (annual))
- Appendix N 4. Report on the release and sale of narcotic drugs and psychotropic substances (Form N 1-OR (annual))
- Appendix N 5. Report on the import (export) of narcotic drugs and psychotropic substances (Form N 1-BB (quarterly))
- Annex No. 5(1). Report on the import (export) of substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list (Form N 2-BB (quarterly))
- Appendix N 6
- Appendix N 7. Report on the use of narcotic drugs and psychotropic substances (Form N 1-ISP (annual))
- Appendix N 8. Report on the production of substances under international control, not included in the list (Form N 2-P (annual)). - Lost power
- Appendix N 9. Report on the production of medicines containing substances under international control, not included in the list (Form N 2-PLS (annual)). - Lost power
- Appendix N 10. Report on the import (export) of substances under international control, not included in the list (Form N 2-BB (quarterly)). - Lost power
- Appendix N 11. Information on the need for narcotic drugs and psychotropic substances (Form N 3-P (annual))
GOVERNMENT OF THE RUSSIAN FEDERATION
ON THE PROCEDURE FOR SUBMISSION OF INFORMATION
ABOUT ACTIVITIES RELATED TO
AND PSYCHOTROPIC SUBSTANCES AND REGISTRATION OF OPERATIONS RELATED
WITH PSYCHOTROPIC SUBSTANCES
In order to ensure state control over the circulation of narcotic drugs and psychotropic substances in accordance with the Federal Law "On Narcotic Drugs and Psychotropic Substances", as well as the fulfillment of international obligations arising from the United Nations conventions to which the Russian Federation is a party, the Government of the Russian Federation decides:
1. Approve the attached:
Rules for the presentation of activities related to the circulation of narcotic drugs and psychotropic substances;
Rules for the management and storage of narcotic drugs and psychotropic substances.
2. Recognize as invalid:
Decree of the Government of the Russian Federation of July 28, 2000 N 577 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to this activity" (Collected Legislation of the Russian Federation, 2000, N 33, art. .3397);
paragraph 30 of the amendments that are made to the Decrees of the Government of the Russian Federation approved by the Russian Federation of February 6, 2004 N 51 "On the amendment and invalidation of certain Decrees of the Government of the Russian Federation in connection with the improvement government controlled in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2004, N 8, item 663);
paragraph 18 of the amendments that are made to some acts of the Government of the Russian Federation in connection with the renaming of the Federal Service of the Russian Federation for the Control of Narcotic Drugs and Psychotropic Substances into the Federal Service of the Russian Federation for the Control of Drugs, approved by the Decree of the Government of the Russian Federation of November 17, 2004 N 648 "On Amendments to Certain Acts of the Government of the Russian Federation in Connection with the Renaming of the Federal Service of the Russian Federation for the Control of Narcotic Drugs and Psychotropic Substances into the Federal Service of the Russian Federation for the Control of Drugs" (Collected Legislation of the Russian Federation, 2004, N 47, item 4666).
Prime Minister
Russian Federation
M. FRADKOV
Approved
Government Decree
Russian Federation
of November 4, 2006 N 644
REGULATIONS
REPORTING BY LEGAL ENTITIES
ON ACTIVITIES RELATED TO THE TRAFFIC OF NARCOTIC
DRUGS AND PSYCHOTROPIC SUBSTANCES
1. These Rules establish the order of submission:
reports on activities related to the circulation of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved (hereinafter respectively - narcotic drugs and psychotropic substances, the list), and information on their stocks as of December 31 of the reporting year;
reports on activities related to the circulation of substances under international control in accordance with the Convention on Psychotropic Substances of 1971 (hereinafter referred to as substances under international control), not included in the list, and information on their stocks as of December 31 of the reporting year ;
information on the annual need of the Russian Federation for narcotic drugs and psychotropic substances, as well as substances under international control that are not included in the list.
2. Legal entities - holders of licenses to carry out activities related to the circulation of narcotic drugs and psychotropic substances, are obliged to report on the quantity of each produced, manufactured, imported (exported), dispensed and sold narcotic drug and psychotropic substance, as well as on their stocks according to as of December 31 of the reporting year.
The quantity and stocks of narcotic drugs and psychotropic substances in the reports are indicated in terms of the active narcotic drug and psychotropic substance.
2(1). Legal entities engaged in activities related to the circulation of substances under international control not included in the list are required to report on the quantity of each produced, imported (exported) substance under international control not included in the list, as well as on its stocks according to as of December 31 of the reporting year.
Quantities and stocks of substances under international control not included in the list are reported in terms of the active substance under international control not included in the list.
3. Legal entities engaged in the production, dispensing and sale of narcotic drugs and psychotropic substances in accordance with the established procedure shall submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 1:
quarterly reports on the quantity of narcotic drugs and psychotropic substances produced - no later than May 15, August 15, November 15, February 15 of the year;
annual report on the number of produced, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their production for the year following the current year - annually, no later than February 15 (under the current one follows understand the year in which the accounts are submitted).
3(1). Legal entities engaged in the established procedure for the production of substances under international control, not included in the list, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 1 (1):
an annual report on the number of produced substances under international control that are not included in the list;
information on stocks of substances under international control, not included in the list, as of December 31 of the reporting year and the plan for their production for the year following the current year.
4. Legal entities engaged in the established procedure for the manufacture, dispensing and sale of narcotic drugs and psychotropic substances, with the exception of pharmacy organizations, medical organizations with pharmacy organizations, medical organizations located in rural settlements and areas remote from settlements in which there are no pharmacy organizations, and medical organizations with separate subdivisions located in rural and remote settlements in which there are no pharmacy organizations, submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 2:
quarterly reports on the number of manufactured narcotic drugs and psychotropic substances - no later than May 15, August 15, November 15, February 15 of the year;
an annual report on the quantity of manufactured, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their manufacture for the year following the current year - annually, no later than February 15.
Copies of the reports are sent within the specified time to the Ministry of Internal Affairs of the Russian Federation.
5. Legal entities engaged in the established procedure for the production of medicinal products not included in the list, containing a small amount of narcotic drugs and psychotropic substances, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3:
an annual report on the quantity of narcotic drugs and psychotropic substances used for the production of medicinal products not included in the list, containing a small amount of narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their use for the production of medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances for the year following the current year.
5(1). Legal entities that duly manufacture medicines containing substances under international control that are not included in the list annually, no later than February 15, submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3 (1):
an annual report on the number of substances under international control, not included in the list, used for the manufacture of medicines;
information on the stocks of substances under international control, not included in the list, as of December 31 of the reporting year and the planned volume of their use for the production of medicines for the year following the current year.
6. Legal entities dispensing and selling narcotic drugs and psychotropic substances in accordance with the established procedure through wholesale trade organizations submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 4:
an annual report on the number of dispensed and sold narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their release and sale for the year following the current year.
Copies of the reports are sent within the specified time to the relevant territorial bodies of the Ministry of Internal Affairs of the Russian Federation.
7. Legal entities importing narcotic drugs and psychotropic substances into the customs territory (export from the customs territory) of the Russian Federation in accordance with the established procedure shall submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the number of imported (exported) narcotic drugs and psychotropic substances no later than On the 10th day of the month following the reporting period, in the form in accordance with Appendix No. 5.
7(1). Legal entities that, in accordance with the established procedure, import into the customs territory (export from the customs territory) of the Russian Federation of substances under international control that are not included in the list, submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the amount of imported (exported) substances that are under international control, not included in the list, no later than the 20th day of the month following the reporting period, in the form in accordance with Appendix No. 5 (1).
8. Pharmacy organizations, medical organizations with pharmacy organizations, medical organizations located in rural settlements and areas remote from settlements in which there are no pharmacy organizations, and medical organizations with separate subdivisions located in rural and remote settlements, in which there are no pharmacy organizations engaged in the established procedure for the manufacture of medicines containing narcotic drugs and psychotropic substances, the dispensing and sale of narcotic drugs and psychotropic substances, are submitted annually, no later than February 15, to the relevant territorial bodies of the Ministry of Internal Affairs of the Russian Federation in the form according to Appendix N 6:
an annual report on the number of manufactured, dispensed and sold narcotic drugs and psychotropic substances;
9. Legal entities that, in accordance with the established procedure, use narcotic drugs and psychotropic substances for medical, veterinary, scientific and educational purposes, when conducting examinations with their use or for their identification, submit annually, no later than February 15, to the relevant territorial bodies of the Ministry of Internal Affairs Russian Federation in the form according to Appendix No. 7:
an annual report on the amount of narcotic drugs and psychotropic substances used;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year.
10. The legal entities specified in paragraphs 3, 4 and 6 of these Rules shall attach to their annual reports information on the number of narcotic drugs and psychotropic substances destroyed in accordance with the established procedure.
15. In case of reorganization or liquidation of a legal entity, reports on its activities for the period not included in the last reports submitted before the day of reorganization or liquidation (including information on reserves on the day of reorganization or liquidation) are submitted in the following order:
in case of reorganization - by a legal entity or its successor (successors) in accordance with the deed of transfer or separation balance sheet;
in case of liquidation - by a legal entity or a liquidation commission no later than the day following the day of its exclusion from the Unified State Register of Legal Entities.
16. The Ministry of Industry and Trade of the Russian Federation, on the basis of reports received in accordance with paragraphs 3 - 6 of these Rules, draws up consolidated quarterly reports no later than June 15, September 15, December 15, March 15 of the year and annual reports no later than March 15 of the year forms in accordance with Annexes No. 1 - 4 and submit them to the Ministry of Internal Affairs of the Russian Federation.
17. The Ministry of Industry and Trade of the Russian Federation, on the basis of the reports received in accordance with paragraphs 7 and 7(1) of these Rules, draws up consolidated quarterly reports and submits them to the Ministry of Internal Affairs of the Russian Federation:
no later than the 20th day of the month following the reporting period - in the form in accordance with Appendix No. 5;
The reports provide data for each legal entity.
Copies of the reports are sent within the specified time to the Ministry of Health of the Russian Federation.
18. The Ministry of Health of the Russian Federation, taking into account the consolidated reports received in accordance with paragraphs 16 and 17 of these Rules, determines for the year following the current year the need of the Russian Federation for narcotic drugs and psychotropic substances, as well as substances under international control, not included in the list.
Information on the need for narcotic drugs and psychotropic substances for the next year is submitted to the Ministry of Internal Affairs of the Russian Federation no later than May 31 of the current year in the form in accordance with Appendix No. 11.
Information on the need for substances under international control that are not included in the list for the next year is submitted to the Ministry of Internal Affairs of the Russian Federation no later than May 31 of the current year in the form in accordance with Appendix No. 13.
The information given in Appendices Nos. 11 and 13 to these Rules is accompanied by a description of the method used to determine the need for them, as well as information on the number of doctors and dentists practicing in the Russian Federation, the number of pharmacies, medical organizations and hospital beds.
19. The Ministry of Internal Affairs of the Russian Federation uses the information contained in the reports:
to carry out, in accordance with the established procedure, control over the circulation in the Russian Federation of narcotic drugs and psychotropic substances, as well as substances under international control that are not included in the list;
to confirm the compliance of information on activities related to the circulation of narcotic drugs and psychotropic substances with state quotas, within which the production, storage and import (export) of narcotic drugs and psychotropic substances are carried out annually, established by Decree of the Government of the Russian Federation dated June 22, 2009 N 508;
to draw up reports of the Russian Federation on the types of activities related to the circulation of narcotic drugs and psychotropic substances, as well as substances under international control, not included in the list, according to the forms in accordance with the international treaties of the Russian Federation and to submit them to the International Control Committee over drugs in the manner prescribed by this Committee.
Copies of reports are sent to the Ministry of Foreign Affairs of the Russian Federation.
Appendix No. 1
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the production, dispensing and sale of narcotic drugs and psychotropic substances for _______________ 20__ Form N 1-P quarterly, annual __________________________________________________________________ (name of the legal entity) TIN ______________________________________________________________ (taxpayer identification number) OGRN _____________________________________________________________ (main state registration number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (phone, fax, e-mail address) License _______________________________________________________________ __________________________________________________________________ (number, validity period) (grams) Head of the legal entity _____________________ _____________________ (surname, initials) (signature ) Official responsible for filling out the form _____________ _______________ ____________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of telephone) of the report)
Annex No. 1(1)
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the production of substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list, for 20__ Form N 2-P annual main state registration number) Location of the legal entity __________________________________________ ___________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ (phone, fax, e-mail address) License __________________________________________________________________ ________________________ ___________________________________________________ (number, expiration date) (grams)
Substance name | Produced during the reporting period | Inventory as of December 31 of the reporting year | Production plan for the year following the current year | pharmaceutical substance | medicinal product | pharmaceutical substance | medicinal product | pharmaceutical substance | medicinal product | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Appendix No. 2
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the manufacture, sale and sale of narcotic drugs and psychotropic substances for _______________ 20__ Form N 1st quarterly, annual __________________________________________________________________ (name of legal entity) TIN ______________________________________________________________ (taxpayer identification number) OGRN ____________________________________________________________________________ (main state registration number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (phone, fax, e-mail address) License _______________________________________________________________ (number, validity period) (grams) Head of legal entity _____________________ _____________________ (last name, initials) (signature) Official responsible for completing the form ____________ _ _______________ ____________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of the telephone) of the report)
Appendix No. 3
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the use of narcotic drugs and psychotropic substances for the production of medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances for 20__ Form N 1-IMS annual __________________________________________________________________ (name of legal entity) TIN ______________________________________________________________ (taxpayer identification number) PSRN _______________________________________________________________ (main state registration number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (telephone, fax, e-mail address) License _______________________________________________________________ ________________________________________________________________________________ (number, validity period) (grams) Manage legal entity _____________________ _______________________ (surname, initials) (signature) Official responsible for filling out the form _____________ _______________ ______________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of telephone) of the report)
Annex No. 3(1)
to the Submission Rules
legal entities reports on
activities related to
drug trafficking
and psychotropic substances
REPORT on the production of medicinal products containing substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list, for 20__ Form N 2-PLS annual ) OGRN ____________________________________________________________________________ (main state registration number) Location of legal entity ________________________________________ _________________________________________________________________________________ _________________________________________________________________ _________________________________________________________________________________ (phone, fax, e-mail address) License ___________________________________________________________ _____________ ___________________________________________________________________________ (number, validity period) (grams) Head of the legal entity _________________________ _____________________ (last name, initials) (signature) Official responsible for filling out the form _______________ _______________________ ____________ (position) (last name, initials) (signature) __________________ _________________________ (phone number ) (date of report)
Appendix No. 4
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the sale and sale of narcotic drugs and psychotropic substances for 20__ Form N 1-OR annual __________________________________________________________________ (name of the legal entity) TIN ______________________________________________________________ (taxpayer identification number) OGRN _____________________________________________________________ (main state registration number) Location of the legal entity _________________________________ ________________________________________________________________ ________________________________________________________________ (phone , fax, e-mail address) License _______________________________________________________________ __________________________________________________________________ (number, validity period) (grams) Head of the legal entity _____________________ _______________________ (surname, initials) (signature) The official responsible for the Completion of the form _____________ _______________ ______________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of the telephone) of the report)
Appendix No. 5
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the import (export) of narcotic drugs and psychotropic substances for ___________ 20__ (quarter) Form N 1-BB quarterly __________________________________________________________________ (name of the legal entity) TIN ______________________________________________________________ (taxpayer identification number) OGRN ____________________________________________________________________________ (main state registration number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (telephone, fax, e-mail) (kilograms)
Name of the narcotic drug, psychotropic substance | Imported for the reporting period | Exported during the reporting period | number | state | base (GTE) | number | state | base (GTE) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Appendix No. 5(1)
to the Submission Rules
legal entities reports on
activities related to
drug trafficking
and psychotropic substances
REPORT on the import (export) of substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list, for ___________ 20__ (quarter) taxpayer identification number) OGRN ________________________________________________________________________ (main state registration number) Location of the legal entity ______________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ ___________________________________________________________________________ (phone, fax, e-mail address) (kilograms)
Import (export) license (number, validity period) | Substance name | Quantity specified in the license | Imported for the reporting period | Exported during the reporting period | number | state | base (GTE) | number | state | base (GTE) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Appendix No. 6
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the manufacture of medicines containing narcotic drugs and psychotropic substances, the release and sale of narcotic drugs and psychotropic substances for 20__ Form N 1-ORAU annual __________________________________________________________________ (name of legal entity) TIN ______________________________________________________________ (taxpayer identification number) number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (telephone, fax, e-mail address) License _______________________________________________________________ __________________________________________________________________ (number, validity period) (grams) Head of the legal entity _______________ ______ _______________________ (surname, initials) (signature) Official responsible for filling out the form ______ _______________ ______________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of telephone) of the report)
Appendix No. 7
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT on the use of narcotic drugs and psychotropic substances for 20__ Form N 1-ISP annual __________________________________________________________________ (name of legal entity) TIN ______________________________________________________________ (taxpayer identification number) OGRN _____________________________________________________________ (main state registration number) Location of the legal entity _______________________________ __________________________________________________________________ __________________________________________________________________ (phone, fax , e-mail address) License _______________________________________________________________ __________________________________________________________________ (number, validity period) (grams) Head of the legal entity _____________________ _______________________ (surname, initials) (signature) The official responsible for filling out form _____________ _______________ ______________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of telephone) of the report)
Appendix No. 8
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
on the production of substances that are
under international control, not included in the list,
for 20__
Appendix No. 9
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
on the production of medicinal
products containing substances that are
under international control, not included
to the list for 20__
Appendix No. 10
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
on the import (export) of substances under international
control, not included in the list,
for ___________ 20__
(quarter)
Appendix No. 11
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
INFORMATION on the need for narcotic drugs and psychotropic substances for 20__ (the year following the current year is indicated) Form N 3-P annual __________________________________________________________________ (name of the federal executive body) mail) (grams) Head of the federal executive body _____________________ _____________________ (surname, initials) (signature) The official responsible for filling out the form _____________ _______________ ______________ (position) (surname, (signature) initials) _____________ ______________________ (number (date of telephone compilation) report)
Appendix No. 12
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
INTELLIGENCE
about the need for substances that are
under international control, not included
to the list for 20__
Appendix No. 13
to the Submission Rules
legal entities reports on
activities related to
drug trafficking
and psychotropic substances
INFORMATION on the need for substances under international control in accordance with the Convention on Psychotropic Substances of 1971, not included in the list, for 20__ (the year following the current year is indicated) Form N 4-P __________________________________________________________________________________________ (name of the federal executive body ) Location of the legal entity ______________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ _________________________________________________________________________________ (telephone, fax, e-mail) (grams) Head of the legal entity _________________________ _____________________ (surname, initials) (signature) Official responsible for filling out the form _________________ _______________________ ____________ (position) (surname, initials) (signature) ________ __________ _________________________ (phone number) (date of report)
Approved
Government Decree
Russian Federation
of November 4, 2006 N 644
REGULATIONS
KEEPING AND STORING SPECIAL REGISTRATION LOGS
OPERATIONS RELATED TO THE TRAFFIC OF NARCOTIC DRUGS
AND PSYCHOTROPIC SUBSTANCES
1. These Rules establish the procedure for maintaining and storing special registers for registering transactions related to the circulation of narcotic drugs and psychotropic substances included in 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 referred to as narcotic drugs and psychotropic substances), as a result of which the quantity and condition of narcotic drugs and psychotropic substances change.
2. These Rules do not apply to the maintenance and storage of special registers of transactions related to the circulation of narcotic drugs and psychotropic substances (hereinafter referred to as registers), in cases where the use of narcotic drugs and psychotropic substances without a license is allowed in order to implement Articles 35 and 36 Federal Law "On Narcotic Drugs and Psychotropic Substances".
3. Legal entities, as well as their subdivisions, carrying out activities related to the circulation of narcotic drugs and psychotropic substances, are required to keep registration logs in the form in accordance with Appendix No. 1 on paper or in electronic form.
4. Registration of transactions related to the circulation of narcotic drugs and psychotropic substances is carried out for each name of the narcotic drug and psychotropic substance on a separate expanded sheet of the registration log or in a separate registration log.
5. When carrying out activities related to the circulation of narcotic drugs and psychotropic substances, any operations that result in a change in the quantity and condition of narcotic drugs and psychotropic substances shall be entered in the register.
The definition of the accounting unit when changing the quantity and condition of narcotic drugs and psychotropic substances is determined by the head of the legal entity or the head structural unit legal entity, taking into account the form of release of the corresponding narcotic drug and psychotropic substance.
6. Registration logs issued on paper must be bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity (if there is a seal).
If necessary, the decision of the executive authority of the constituent entity of the Russian Federation determines the body that certifies the registration log, provided for in Appendix No. 1 to these Rules.
Sheets of registration logs filled in electronic form are monthly printed out, numbered, signed by the person responsible for their maintenance and storage, and brochured by the name of the narcotic drug or psychotropic substance, dosage, dosage form (if the narcotic drug or psychotropic substance is a medicinal product). ).
After the expiration of the calendar year, monthly bound pages of the registration log are drawn up in the registration log, sealed with an indication of the number of sheets and certified by the signature of the person responsible for maintaining and storing the registration log, the head of the legal entity and the seal of the legal entity (if there is a seal).
7. The head of the legal entity appoints persons responsible for the maintenance and storage of registration logs, including in subdivisions.
8. Entries in the registration logs shall be made by the person responsible for their maintenance and storage, with a frequency established by the head of the legal entity, but at least once during the day of transactions with narcotic drugs and psychotropic substances on the basis of documents confirming the performance of these transactions.
Documents or their copies confirming the completion of a transaction with a narcotic drug or psychotropic substance, duly certified, are either filed in a separate folder, which is stored together with the relevant registration log, or stored in the archive of a legal entity with the possibility of presenting them at the request of regulatory authorities.
9. Has become invalid since July 22, 2010. - .
10. The registration logs shall indicate both the names of narcotic drugs and psychotropic substances in accordance with the list specified in paragraph 1 of these Rules, and other names of narcotic drugs and psychotropic substances under which they were received by the legal entity.
Lists of names of narcotic drugs and psychotropic substances registered as medicines (international non-proprietary, proprietary, original names or in their absence chemical names), are entered by the Ministry of Health of the Russian Federation in the state register of medicinal products for medical use, the Federal Service for Veterinary and Phytosanitary Surveillance - in the state register of medicinal products for veterinary use.
11. The numbering of entries in the registers for each name of a narcotic drug or psychotropic substance is carried out within a calendar year in ascending order of numbers. The numbering of entries in new logbooks starts from the number following the last number in the completed logbooks.
Pages of paper-based registration journals not used in the current calendar year are crossed out and not used in the next calendar year.
12. An entry in the registration logs of each transaction performed is certified by a signature, including an enhanced qualified electronic signature, of the person responsible for their maintenance and storage, indicating the surname and initials.
13. Corrections in the registration logs, drawn up on paper, are certified by the signature of the person responsible for their maintenance and storage. Erasures and uncertified corrections in paper-based registration logs are not allowed.
14. Legal entities conduct monthly, in accordance with the established procedure, an inventory of narcotic drugs and psychotropic substances by comparing their actual availability with accounting data (book balances).
The registration logs must reflect the results of the inventory of narcotic drugs and psychotropic substances.
The paragraph became invalid as of July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
15. The registration log is stored in a metal cabinet (safe) in a technically fortified room. The keys to the metal cabinet (safe) and the technically fortified room are held by the person responsible for maintaining and storing the registration log.
Access to information system, with the help of which the registration log is maintained in electronic form, have persons responsible for maintaining and storing the registration log.
16. Has become invalid since July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
17. On the basis of entries in the relevant register, legal entities submit, in accordance with the established procedure, reports on activities related to the circulation of narcotic drugs and psychotropic substances.
18. Completed registration logs, together with documents confirming the implementation of operations related to the circulation of narcotic drugs and psychotropic substances, are handed over to the archive of a legal entity, where they are stored for 5 years after the last entry is made in them. After the expiration of the specified period, the registration logs are subject to destruction according to an act approved by the head of the legal entity.
19. In case of reorganization or liquidation of a legal entity, registration logs and documents confirming the implementation of operations related to the circulation of narcotic drugs and psychotropic substances shall be deposited:
in case of reorganization - to a new legal entity or successor (successors) in accordance with the deed of transfer or separation balance sheet;
upon liquidation - in state archive in accordance with the legislation of the Russian Federation.
Appendix No. 1
special registers
operations related to turnover
drugs
and psychotropic substances
Month | Balance on the first business day of the month | Coming | Arrival with the balance for the month - total | Consumption | Balance on the last business day of the month | Actual balance on the last business day of the month | Inventory note | date | arrival transaction number | name, N and date of receipt document | number | income per month - total | date | expense transaction number | name, N and date of the expense document | number | surname, initials, signature of the responsible person | expenses per month - total | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 |
Appendix No. 2
to the Rules for maintaining and storing
special registers
operations related to turnover
narcotic drugs, psychotropic
substances and their precursors
Magazine
registration of transactions related to the turnover
drug precursors
and psychotropic substances
GOVERNMENT OF THE RUSSIAN FEDERATION
RESOLUTION
November 4, 2006
No. 644
ON THE PROCEDURE FOR SUBMISSION OF INFORMATION ON ACTIVITIES RELATED TO TRAFFIC IN NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES AND REGISTRATION OF OPERATIONS RELATED TO TRAFFIC IN NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES
dated 09.06.2010 N 419)
In order to ensure state control over the circulation of narcotic drugs and psychotropic substances in accordance with the Federal Law "On Narcotic Drugs and Psychotropic Substances", as well as the fulfillment of international obligations arising from the United Nations conventions to which the Russian Federation is a party, the Government of the Russian Federation decides:
1. Approve the attached:
Rules for the submission by legal entities of reports on activities related to the circulation of narcotic drugs and psychotropic substances;
Rules for maintaining and storing special registers for registering operations related to the circulation of narcotic drugs and psychotropic substances.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
2. Recognize as invalid:
Decree of the Government of the Russian Federation of July 28, 2000 N 577 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to this activity" (Collected Legislation of the Russian Federation, 2000, N 33, art. .3397);
paragraph 30 of the amendments that are made to the Decrees of the Government of the Russian Federation approved by the Decree of the Government of the Russian Federation of February 6, 2004 N 51 "On the amendment and invalidation of certain Decrees of the Government of the Russian Federation in connection with the improvement of public administration in the Russian Federation" (Collection of Legislation Russian Federation, 2004, N 8, item 663);
paragraph 18 of the amendments that are made to some acts of the Government of the Russian Federation in connection with the renaming of the Federal Service of the Russian Federation for the Control of Narcotic Drugs and Psychotropic Substances into the Federal Service of the Russian Federation for the Control of Drugs, approved by the Decree of the Government of the Russian Federation of November 17, 2004 N 648 "On Amendments to Certain Acts of the Government of the Russian Federation in Connection with the Renaming of the Federal Service of the Russian Federation for the Control of Narcotic Drugs and Psychotropic Substances into the Federal Service of the Russian Federation for the Control of Drugs" (Collected Legislation of the Russian Federation, 2004, N 47, item 4666).
Prime Minister
Russian Federation
M. FRADKOV
APPROVED
Government Decree
Russian Federation
RULES FOR REPORTING BY LEGAL ENTITIES ON ACTIVITIES RELATED TO THE TRAFFIC OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES
(as amended by Decrees of the Government of the Russian Federation of December 8, 2008 N 917,
dated 09.06.2010 N 419)
1. These Rules, in accordance with Article 37 of the Federal Law "On Narcotic Drugs and Psychotropic Substances", establish the procedure for submitting:
reports on activities related to the circulation of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, item 3198; 2006, N 29, item 3253) (hereinafter - narcotic drugs and psychotropic substances), and information about their stocks as of December 31 of the reporting year;
reports on activities related to the circulation of substances under international control in accordance with the Convention on Psychotropic Substances of 1971 (hereinafter - substances under international control), not included in the list of narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2006, N 29, Art. 3253) (hereinafter referred to as the list), and information about their stocks as of December 31 of the reporting year;
information on the annual need of the Russian Federation for narcotic drugs, psychotropic substances and substances under international control not included in the list.
2. Legal entities - holders of licenses to carry out activities related to the circulation of narcotic drugs and psychotropic substances, are obliged to report on the quantity of each produced, manufactured, imported (exported), dispensed and sold narcotic drug and psychotropic substance, as well as on their stocks according to as of December 31 of the reporting year.
The quantity and stocks of narcotic drugs and psychotropic substances in the reports are indicated in terms of the active narcotic drug and psychotropic substance.
3. Legal entities engaged in the production, dispensing and sale of narcotic drugs and psychotropic substances in accordance with the established procedure shall submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 1:
quarterly reports on the quantity of narcotic drugs and psychotropic substances produced - no later than May 15, August 15, November 15, February 15 of the year;
annual report on the number of produced, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their production for the year following the current year - annually, no later than February 15 (under the current one follows understand the year in which the accounts are submitted).
4. Legal entities that manufacture, dispense and sell narcotic drugs and psychotropic substances in accordance with the established procedure, with the exception of pharmacies and medical institutions with pharmacies, submit to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 2:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
quarterly reports on the number of manufactured narcotic drugs and psychotropic substances - no later than May 15, August 15, November 15, February 15 of the year;
an annual report on the quantity of manufactured, dispensed and sold narcotic drugs and psychotropic substances, information on their stocks as of December 31 of the reporting year and on the plan for their manufacture for the year following the current year - annually, no later than February 15.
Copies of the reports are sent within the specified time to the Federal Drug Control Service of the Russian Federation.
5. Legal entities engaged in the established procedure for the production of medicinal products not included in the list, containing a small amount of narcotic drugs and psychotropic substances, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 3:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
an annual report on the quantity of narcotic drugs and psychotropic substances used for the production of medicinal products not included in the list, containing a small amount of narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their use for the production of medicines not included in the list containing a small amount of narcotic drugs and psychotropic substances for the year following the current year.
6. Legal entities dispensing and selling narcotic drugs and psychotropic substances in accordance with the established procedure through wholesale trade organizations submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 4:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
an annual report on the number of dispensed and sold narcotic drugs and psychotropic substances;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year and on the planned volume of their release and sale for the year following the current year.
Copies of the reports are sent within the specified time to the relevant territorial bodies of the Federal Service of the Russian Federation for Drug Control.
7. Legal entities importing narcotic drugs and psychotropic substances into the customs territory (export from the customs territory) of the Russian Federation in accordance with the established procedure shall submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the number of imported (exported) narcotic drugs and psychotropic substances no later than On the 10th day of the month following the reporting period, in the form in accordance with Appendix No. 5.
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
8. Pharmacy institutions and medical institutions with pharmacies that carry out in accordance with the established procedure the manufacture of medicines containing narcotic drugs and psychotropic substances, the release and sale of narcotic drugs and psychotropic substances, submit annually, no later than February 15, to the relevant territorial bodies of the Federal Service of the Russian Federation for the control of drug trafficking in the form in accordance with Appendix No. 6:
an annual report on the number of manufactured, dispensed and sold narcotic drugs and psychotropic substances;
9. Legal entities that, in accordance with the established procedure, use narcotic drugs and psychotropic substances for medical, veterinary, scientific and educational purposes, when conducting examinations with their use or for their identification, submit annually, no later than February 15, to the relevant territorial bodies of the Federal Service of the Russian Drug Control Federation in the form according to Appendix No. 7:
an annual report on the amount of narcotic drugs and psychotropic substances used;
information on stocks of narcotic drugs and psychotropic substances as of December 31 of the reporting year.
10. The legal entities specified in paragraphs 3, 4 and 6 of these Rules shall attach to their annual reports information on the number of narcotic drugs and psychotropic substances destroyed in accordance with the established procedure.
11. Legal entities engaged in activities related to the circulation of substances under international control not included in the list are required to report on the quantity of each produced, imported (exported) substance under international control not included in the list, as well as on its inventory as of December 31 of the reporting year.
Quantities and stocks of substances under international control not included in the list are reported in terms of the active substance under international control not included in the list.
12. Legal entities engaged in the established procedure for the production of substances under international control, not included in the list, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 8:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
an annual report on the number of produced substances under international control that are not included in the list;
information on stocks of substances under international control, not included in the list, as of December 31 of the reporting year and on the plan for their production for the year following the current year.
13. Legal entities engaged in the established procedure for the production of medicines containing substances under international control, not included in the list, submit annually, no later than February 15, to the Ministry of Industry and Trade of the Russian Federation in the form in accordance with Appendix No. 9:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
an annual report on the number of substances under international control, not included in the list, used for the manufacture of medicines;
information on stocks of substances under international control, not included in the list, as of December 31 of the reporting year and on the planned volume of their use for the production of medicines for the year following the current year.
14. Legal entities importing into the customs territory (export from the customs territory) of the Russian Federation, in accordance with the established procedure, substances under international control, not included in the list, submit to the Ministry of Industry and Trade of the Russian Federation quarterly reports on the amount of imported (exported) substances under international control, not included in the list, no later than the 20th day of the month following the reporting period, in the form in accordance with Appendix No. 10.
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
15. In case of reorganization or liquidation of a legal entity, reports on its activities for the period not included in the last reports submitted before the day of reorganization or liquidation (including information on reserves on the day of reorganization or liquidation) are submitted in the following order:
in case of reorganization - by a legal entity or its successor (successors) in accordance with the deed of transfer or separation balance sheet;
in case of liquidation - by a legal entity or a liquidation commission no later than the day following the day of its exclusion from the Unified State Register of Legal Entities.
16. The Ministry of Industry and Trade of the Russian Federation, on the basis of the reports received in accordance with paragraphs 3-6, 12 and 13 of these Rules, shall draw up consolidated quarterly reports no later than June 15, September 15, December 15, March 15 of the year and annual reports no later than March 15 of the year according to the forms in accordance with Annexes No. 1-4, 8 and 9 and submit them to the Federal Drug Control Service of the Russian Federation.
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
17. The Ministry of Industry and Trade of the Russian Federation, on the basis of the reports received in accordance with paragraphs 7 and 14 of these Rules, draws up consolidated quarterly reports and submits them to the Federal Drug Control Service of the Russian Federation:
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
no later than the 20th day of the month following the reporting period - in the form in accordance with Appendix No. 5;
no later than May 25, August 25, November 25, February 25 of the year - in the form in accordance with Appendix No. 10.
The reports provide data for each legal entity.
Copies of the reports are sent within the specified time to the Ministry of Health and social development Russian Federation.
(as amended by Decree of the Government of the Russian Federation of 08.12.2008 N 917)
18. The Ministry of Health and Social Development of the Russian Federation, taking into account the consolidated reports received in accordance with paragraphs 16 and 17 of these Rules, determines for the year following the current year the need of the Russian Federation for narcotic drugs, psychotropic substances and substances under international control not included in the list.
Information on the need for narcotic drugs, psychotropic substances and substances under international control, not included in the list, for the next year shall be submitted to the Federal Drug Control Service of the Russian Federation no later than May 31 of the current year using the forms in accordance with Appendix No. 11 and 12. The information is accompanied by a description of the method used to determine the need for them, as well as information on the number of doctors and dentists practicing in the Russian Federation, the number of pharmacies, medical institutions and hospital beds.
19. The Federal Drug Control Service of the Russian Federation uses the information contained in the reports:
to carry out, in accordance with the established procedure, control over the circulation in the Russian Federation of narcotic drugs, psychotropic substances and substances under international control, not included in the list;
to confirm the compliance of information on activities related to the circulation of narcotic drugs and psychotropic substances with state quotas within which the production, storage and import (export) of narcotic drugs and psychotropic substances are carried out annually, established by Decree of the Government of the Russian Federation dated June 22, 2009 N 508;
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
to draw up reports of the Russian Federation on the types of activities related to the circulation of narcotic drugs, psychotropic substances and substances under international control, not included in the list, in the forms in accordance with the international treaties of the Russian Federation and to submit them to the International Narcotics Control Board in the manner prescribed by this Committee.
Copies of reports are sent to the Ministry of Foreign Affairs of the Russian Federation.
Appendix No. 1
to the Submission Rules
activities related to
psychotropic substances
REPORT
About production, release and sale
For _______________ 20__
Form N 1-P
quarterly, annual
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
Produced |
Released |
Plan |
|
Supervisor
Executive,
responsible
Initials)
(number (date of compilation
telephone) report)
Appendix No. 2
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the manufacture, release and sale
Narcotic drugs and psychotropic substances
For _______________ 20__
Form N 1-I
quarterly, annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
(number, expiration date)
(grams)
Name |
Manufactured |
Released |
Plan |
|
Supervisor
legal entity _____________________ _____________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ____________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 3
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
And psychotropic substances for production
Medicines not included in the list
Form N 1-IMS
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
used |
Planned volume |
|
Supervisor
(surname, initials) (signature)
Executive,
responsible
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 4
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the sale and sale of narcotic drugs
And psychotropic substances for 20__
Form N 1-OP
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
Released and |
Planned volume |
|
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 5
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the import (export) of narcotic drugs
and psychotropic substances
For ___________ 20__
(quarter)
Form N 1-BB
quarterly
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
(kilograms)
License for |
Name |
Quantity, |
Imported for the reporting period |
Exported during the reporting period |
||||
if- |
state- |
the foundation- |
if- |
state- |
base |
|||
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 6
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the manufacture of medicines
Substances, dispensing and sale of narcotic drugs
and psychotropic substances
For 20__
Form N 1-ORAU
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
Manufactured |
Released and implemented |
|
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 7
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
About the use of drugs
and psychotropic substances
For 20__
Form N 1-ISP
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
used |
|
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 8
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the production of substances that are
Under international control, not included in the list,
For 20__
Form N 2-P
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
Produced |
Production plan for |
||||
pharmacists |
medication |
pharmacists |
medication |
pharmacists |
medication |
|
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 9
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
About the production of medicinal
Products containing substances that are
Under international control, not included
Listed for 20__
Form N 2-PLS
Annual
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
License _________________________________________________________
__________________________________________________________________
(number, expiration date)
(grams)
Name |
used |
Planned volume |
|
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 10
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
REPORT
On the import (export) of substances under international
Controls not included in the list,
For ___________ 20__
(quarter)
Form N 2-BB
quarterly
__________________________________________________________________
(name of the legal entity)
TIN ________________________________________________________________
(tax identification number)
OGRN _____________________________________________________________
(main state registration number)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
(kilograms)
License for |
Name |
Quantity, |
Imported for the reporting period |
Exported during the reporting period |
||||
if- |
state- |
base |
if- |
state- |
base |
|||
Supervisor
legal entity _____________________ _______________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 11
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
INTELLIGENCE
On the need for drugs
and psychotropic substances
For 20__
Form N 3-P
Annual
__________________________________________________________________
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
(grams)
Name |
Intended |
Designed for |
|
Supervisor
federal body
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
Initials)
_____________ ______________________
(number (date of compilation
telephone) report)
Appendix No. 12
to the Submission Rules
legal entities reports on
activities related to
drug trafficking and
psychotropic substances
INTELLIGENCE
about the need for substances that are
under international control, not included
to the list for 20__
(indicate the year following the current year)
Form N 4-P
annual
__________________________________________________________________
(name of the federal executive body)
Location of the legal entity _______________________________
__________________________________________________________________
__________________________________________________________________
(telephone, fax, e-mail)
(grams)
Substance name |
Intended for consumption inside |
1 |
2 |
Supervisor
federal body
executive power _____________________ _____________________
(surname, initials) (signature)
Executive,
responsible
for filling out the form _____________ _______________ ______________
(position) (surname, (signature)
initials)
_____________ ______________________
(number (date of compilation
phone) report)
APPROVED
Government Decree
Russian Federation
RULES OF MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR REGISTRATION OF OPERATIONS RELATED TO THE TRAFFIC OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
1. These Rules establish the procedure for maintaining and storing special registers for registering transactions related to the circulation of narcotic drugs and psychotropic substances included in 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 referred to as narcotic drugs and psychotropic substances), as a result of which the quantity and condition of narcotic drugs and psychotropic substances change.
(clause 1 as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
2. These Rules do not apply to the maintenance and storage of special registers of transactions related to the circulation of narcotic drugs and psychotropic substances (hereinafter referred to as registers), in cases where the use of narcotic drugs and psychotropic substances without a license is allowed in order to implement Articles 35 and 36 Federal Law "On Narcotic Drugs and Psychotropic Substances".
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
3. Legal entities, as well as their subdivisions, carrying out activities related to the circulation of narcotic drugs and psychotropic substances, are required to keep registration logs in the form in accordance with Appendix No. 1.
(clause 3 as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
4. Registration of transactions related to the circulation of narcotic drugs and psychotropic substances is carried out for each name of the narcotic drug and psychotropic substance on a separate expanded sheet of the registration log or in a separate registration log.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
5. When carrying out activities related to the circulation of narcotic drugs and psychotropic substances, any operations that result in a change in the quantity and condition of narcotic drugs and psychotropic substances shall be entered in the register.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
6. Registration logs must be bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity.
If necessary, the decision of the executive authority of the constituent entity of the Russian Federation determines the body that certifies the registration log, provided for in Appendix No. 1 to these Rules.
7. The head of the legal entity appoints persons responsible for the maintenance and storage of registration logs, including in subdivisions.
8. Entries in the registration logs are made by the person responsible for their maintenance and storage, with a ballpoint pen (ink) in chronological order immediately after each operation for each item of a narcotic drug or psychotropic substance on the basis of documents confirming the completion of this operation.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
Documents or their copies confirming the completion of a transaction with a narcotic drug or psychotropic substance, certified in the prescribed manner, are filed in a separate folder, which is stored together with the relevant registration log.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
9. Has become invalid since July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
10. The registration logs shall indicate both the names of narcotic drugs and psychotropic substances in accordance with the list specified in paragraph 1 of these Rules, and other names of narcotic drugs and psychotropic substances under which they were received by the legal entity.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
Lists of names of narcotic drugs and psychotropic substances registered as medicines (international non-proprietary, proprietary, original names or chemical names in their absence) are entered by the Federal Service for Supervision of Health and Social Development in the state register of medicines.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
11. The numbering of entries in the registers for each name of a narcotic drug or psychotropic substance is carried out within a calendar year in ascending order of numbers. The numbering of entries in new logbooks starts from the number following the last number in the completed logbooks.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
Pages of registration logs not used in the current calendar year are crossed out and are not used in the next calendar year.
12. An entry in the registration logs of each operation performed is certified by the signature of the person responsible for their maintenance and storage, indicating the surname and initials.
13. Corrections in the registration logs are certified by the signature of the person responsible for their maintenance and storage. Erasures and uncertified corrections in the logs are not allowed.
14. Legal entities conduct monthly, in accordance with the established procedure, an inventory of narcotic drugs and psychotropic substances by comparing their actual availability with accounting data (book balances).
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
The registration logs must reflect the results of the inventory of narcotic drugs and psychotropic substances.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
The paragraph became invalid as of July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
15. The registration log is stored in a metal cabinet (safe) in a technically fortified room. The keys to the metal cabinet (safe) and the technically fortified room are held by the person responsible for maintaining and storing the registration log.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
16. Has become invalid since July 22, 2010. - Decree of the Government of the Russian Federation of 09.06.2010 N 419.
17. On the basis of entries in the relevant register, legal entities submit, in accordance with the established procedure, reports on activities related to the circulation of narcotic drugs and psychotropic substances.
18. Completed registration logs, together with documents confirming the implementation of operations related to the circulation of narcotic drugs and psychotropic substances, are handed over to the archive of a legal entity, where they are stored for 10 years after the last entry is made in them. After the expiration of the specified period, the registration logs are subject to destruction according to an act approved by the head of the legal entity.
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
19. In case of reorganization or liquidation of a legal entity, registration logs and documents confirming the implementation of operations related to the circulation of narcotic drugs and psychotropic substances shall be deposited:
(as amended by Decree of the Government of the Russian Federation of 09.06.2010 N 419)
in case of reorganization - to a new legal entity or successor (successors) in accordance with the deed of transfer or separation balance sheet;
upon liquidation - to the state archive in accordance with the legislation of the Russian Federation.
Appendix No. 1
drugs
and psychotropic substances
____________________________________
(name of the legal entity)
Magazine
registration of transactions related to the turnover
narcotic drugs and psychotropic substances
__________________________________________________________________
Narcotic drug (psychotropic substance) _______________
__________________________________________________________________
(name, dosage, release form, unit of measure)
month |
remainder |
coming |
Total |
consumption |
remainder |
fact- |
mark |
||||||||
date |
name- |
if- |
surname, |
Total |
date |
name- |
if- |
surname, |
Total |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
Appendix No. 2
to the Rules for maintaining and storing
special registers
operations related to turnover