Order 378 n dated June 17 13. Legislative framework of the Russian Federation

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER

On approval of the rules for registering transactions related to circulation medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting, in special journals of transactions related to the circulation of medicines for medical use, and the rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use

Document with changes made:
by order of the Ministry of Health of Russia dated October 31, 2017 N 882n (Official Internet portal of legal information www.pravo.gov.ru, 01/09/2018, N 0001201801090027);
(Official Internet portal of legal information www.pravo.gov.ru, 05/03/2018, N 0001201805030058).
____________________________________________________________________

In accordance with paragraph 5.2.171_3 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collected Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970) ,

I order:

Approve:

rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

Minister
V.Skvortsova

Registered
at the Ministry of Justice
Russian Federation
August 15, 2013,
registration N 29404

Appendix No. 1. Rules for registration of transactions related to the circulation of medicines for medical use included in the list of medicines for medical use, subject to subject-quantitative accounting...

Appendix No. 1
to the order

Rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use

1. These Rules establish requirements for registration of transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting (hereinafter referred to as medicinal products), as a result of which their quantity changes and (or) state.
________________

2. Registration of transactions related to the circulation of medicines containing narcotic drugs, psychotropic substances and their precursors and included in lists II, III, IV of the list narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, as well as combined medicinal products that contain, in addition to narcotic drugs, psychotropic substances and their precursors, other pharmacologically active substances and for which, in accordance with the regulations, control measures are provided similar to those established in relation to narcotic drugs, psychotropic substances and their precursors contained in them, is carried out by the subjects of circulation of medicines in special journals in the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for recording transactions related to the circulation of narcotic drugs and psychotropic substances, approved Decree of the Government of the Russian Federation dated November 4, 2006 N 644, and the appendix to the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation dated June 9, 2010 N 419.
(Clause as amended, put into effect on May 14, 2018 by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.
________________

Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8 , art. 663; 2006, art. 3253; 2007, no. 3439; 2009, art. 3183; 2010, no. 3; , art. 314; no. 2100; no. 3035; no. 31, art. 4271; no. 5864; art. 6696; ; 2011, N 1390; N 29, Art. 4473; N 42, Art. 5921; 2012, N 10, Art. ; N 11, art. 1295; N 22, art. 2864; N 48, art. 6686; 953; No. 3159; No. 37, No. 4706; No. 5943; 2014, No. 1626; .2987; No. 3763; No. 6068; No. 2015, No. 1593; No. 2368; Art. 4232; N 42, Art. 5805; 2016, N 15, Art. 2088; 2017, N 4, Art. 671, N 10, Art. 1481, N 23, Art. 3330; N 30, art. 4664; N 33, art. 5182).
by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.

Collection of Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, N 30, art. 3033; 2003, N 2, art. 167; N 27, art. 2700; 2004, N 49, art. 4845; 2005, N 19, art. 1752; 2006, N 43, art. 4412; N 44, art. 4535; 2007, N 30, art. 3748; N 31, art. 4011; 2008, N 30, art. 3592; N 48, art. 5515; N 52, art. 6233; 2009, N 29, art. 3588, 3614; 2010, N 21, art. 2525; N 31, art. 4192; 2011, N 1, art. 16, art. 29; N 15, art. 2039; N 25, art. 3532; N 49, art. 7019, art. 7061; 2012, N 10, art. 1166; N 53, art. 7630; 2013, N 23, art. 2878; N 30, art. 4057; N 48, art. 6161, art. 6165; 2014, N 23, art. 2930; 2015, N 1, art. 54; N 6, art. 885; N 29, art. 4388; 2016, N 1, art. 28; N 15, art. 2052; N 27, art. 4160; Article 4238.
(Footnote as amended, put into effect on May 14, 2018 by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.

Collection of Legislation of the Russian Federation, 2006, No. 46, Art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002; 2013, N 6, art. 558, N 51, art. 6869; 2015, N 33, art. 4837; 2017, N 2, art. 375.
(Footnote as amended, put into effect on May 14, 2018 by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.

Collection of Legislation of the Russian Federation, 2010, No. 25, Art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235; 2015, N 33, art. 4837; 2017, N 2, art. 375.
by order of the Ministry of Health of Russia dated April 5, 2018 N 149n)

3. Registration of transactions related to the circulation of medicines (with the exception of medicines specified in paragraph 2 of these Rules) is carried out in special journals for recording operations related to the circulation of medicines (hereinafter referred to as the log books):

1) manufacturers of medicines and organizations wholesale trade medicines in the form according to Appendix No. 1 to these Rules;

2) pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;

3) medical organizations and individual entrepreneurs licensed to medical activities, in the form in accordance with Appendix No. 3 to these Rules.

4. Registration of transactions related to the circulation of medicines is carried out for each trade name of the medicine (for each individual dosage and dosage form) on a separate, expanded sheet of the accounting journal or in separate magazine accounting on paper or in electronic form.

5. Registration of operations related to the circulation of medicines is carried out by persons authorized by the head legal entity for maintaining and storing accounting logs, or an individual entrepreneur with a license for pharmaceutical activities or medical activities.

Appendix No. 1 to the Rules.

Appendix No. 1
to the Rules

Journal of transactions related to the circulation of medicines for medical use

Actually

on the 1st of the month

Received from:

N and document date

If-
quality

month upon arrival with balance

To whom it was released

N and document date

If-
quality

monthly consumption

balance at the end of the month

authorized
new person

June, etc.

Appendix No. 2 to the Rules. Journal of transactions related to the circulation of medicines for medical use

Appendix No. 2
to the Rules

Journal of transactions related to the circulation of medicines for medical use

(name of the medicinal product for medical use)

(dosage, dosage form, unit of measurement)

Expense for

on the 1st of the month

Delivered
Box, N and document date

Quantity

month upon arrival with balance

month for each type separately

month for all types of expenses

according to the accounting journal at the end of the month

balance at the end of the month

authorized
urine-
new person

according to prescriptions

upon request
niyam

February, etc.

according to prescriptions

upon request
niyam

Appendix No. 3 to the Rules. Journal of transactions related to the circulation of medicines for medical use

Journal of transactions related to the circulation of medicines for medical use

(name of the medicinal product for medical use)

(dosage, dosage form, unit of measurement)

Actually

on the 1st of the month

Received from:

N and document date

If-
quality

month upon arrival with balance

date of issue

N medical
whose document (full name of the patient*)

If-
quality

monthly consumption

according to the accounting journal at the end of the month

balance at the end of the month

authorized
valued person

June, etc.

____________________

* Indicated in the case of individual prescription and prescription of a medicine to a specific patient.

Appendix No. 2. Rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use

Appendix No. 2
to the order

1. These Rules establish requirements for maintaining and storing special logs of operations related to the circulation of medicines for medical use included in the list of medicines for medical use, subject to subject-quantitative accounting (hereinafter referred to as log books, medicines).
________________
(Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, N 49, Art. 6409; 2011, N 50, Art. 7351; 2012, N 26, Art. 3446; N 53, Art. 7587).

2. These Rules do not apply to the maintenance and storage of special logs of transactions related to the circulation of medicines containing narcotic drugs, psychotropic substances and their precursors and included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, as well as combined medicinal products that contain, in addition to narcotic drugs, psychotropic substances and their precursors, other pharmacologically active substances and in respect of which, in accordance with paragraph 4 of Article 2 of the Federal Law of January 8, 1998 N 3-FZ " On Narcotic Drugs and Psychotropic Substances" provides for control measures similar to those established for narcotic drugs, psychotropic substances and their precursors contained in them.
Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8 , art. 663; 2006, art. 3253; 2007, no. 3439; 2009, art. 3183; 2010, no. 3; , art. 314; no. 2100; no. 3035; no. 31, art. 4271; no. 5864; art. 6696; ; 2011, N 1390; N 29, Art. 4473; N 42, Art. 5921; 2012, N 10, Art. ; N 11, art. 1295; N 22, art. 2864; N 48, art. 6686; 953; No. 3159; No. 37, No. 4706; No. 5943; 2014, No. 1626; .2987; No. 3763; No. 6068; No. 2015, No. 1593; No. 2368; Art. 4232; N 42, Art. 5805; 2016, N 15, Art. 2088; 2017, N 4, Art. 671, N 10, Art. 1481, N 23, Art. 3330; N 30, art. 4664; N 33, art. 5182).
(Footnote as amended, put into effect on May 14, 2018 by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.

Collection of Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, N 30, art. 3033; 2003, N 2, art. 167; N 27, art. 2700; 2004, N 49, art. 4845; 2005, N 19, art. 1752; 2006, N 43, art. 4412; N 44, art. 4535; 2007, N 30, art. 3748; N 31, art. 4011; 2008, N 30, art. 3592; N 48, art. 5515; N 52, art. 6233; 2009, N 29, art. 3588, 3614; 2010, N 21, art. 2525; "N31, Art. 4192; 2011, N 1, Art. 16, Art. 29; N 15, Art. 2039; N 25; Art. 3532; N 49, Art. 7019, Art. 7061; 2012, N 10, Art. 1166; Art. 7630, 2013, Art. 2878; Art. 4057, Art. 6165; 2014, Art. 2930; 1, art. 54; N 6, art. 885; 2016, N 1, art. 2052;
(Footnote additionally included from May 14, 2018 by order of the Russian Ministry of Health dated April 5, 2018 N 149n)

3. The introduction and storage of special logs of transactions related to the circulation of medicines, specified in paragraph 2 of these Rules, is carried out in accordance with the Rules for maintaining and storing special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by decree of the Government of the Russian Federation dated November 4, 2006 N 644, and the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation dated June 9, 2010 N 419.
________________
Collection of Legislation of the Russian Federation, 2006, No. 46, Art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002.

Collection of Legislation of the Russian Federation, 2010, No. 25, Art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

4. Accounting journals filled out on paper are bound, numbered and sealed with the signature of the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur) before the start of their maintenance.

Accounting logs are prepared for the calendar year.

5. Sheets of accounting logs filled out in electronic form, are printed out monthly, numbered, signed by a person authorized to maintain and store accounting logs, and bookleted by name of the drug, dosage, and dosage form.

At the end of the calendar year, the bound sheets are drawn up in a journal, sealed with an indication of the number of sheets and certified by the signature of the person authorized to maintain and store accounting journals, the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur).

6. Entries in the accounting journals are made by a person authorized to maintain and store the accounting journal, with a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with the medicinal product.

7. The receipt of the medicinal product is reflected in the logbook for each receipt document separately indicating the number and date. Drug consumption is recorded daily. Pharmacy organizations And individual entrepreneurs who have licenses for pharmaceutical activities, record the daily consumption of the drug, indicating separately for prescriptions issued medical workers, and according to the requirements of medical organizations.

8. Corrections in the accounting journals are certified by the signature of the person authorized to maintain and store the accounting journals. Erasures and uncertified corrections in accounting journals are not permitted.

9. On the last day of each month, the person authorized to maintain and store accounting journals checks the actual availability of medicines with their balance in the accounting journal and makes appropriate entries in the accounting journal.

10. The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.

Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.

11. Completed accounting logs are stored in the archives of a legal entity (individual entrepreneur).

Revision of the document taking into account
changes and additions prepared
JSC "Kodeks"

Question: Please provide clarification on Order No. 378n dated June 17, 2013: 1) when (indicate the date) it is necessary to create a log of transactions related to the circulation of medicines for medical use; 2) is it necessary to create the same journal to record ethyl alcohol in an industrial pharmacy?

Answer: In accordance with Part 3 of Article 58.1 Federal Law RF dated 04/12/2010 N 61-FZ "On the circulation of medicines" (as amended on 07/02/2013) subject-quantitative accounting of medicines for medical use is carried out by manufacturers of medicines, wholesale trade organizations of medicines, pharmacy organizations, individual entrepreneurs, having a license for pharmaceutical activities or a license for medical activities, and medical organizations that carry out the circulation of medicines for medical use, by registering any transactions related to their circulation, in which their quantity and (or) condition changes, in special journals for recording transactions related with the circulation of medicines for medical use.
This provision of the Law came into force on June 25, 2013 and, formally, it was from this date that the obligation to maintain journals of medicinal products subject to PCU was established.
However, the Ministry of Health of the Russian Federation, as always, did not approve the Rules for maintaining such journals in a timely manner.
Order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n, which approved the “Rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use" and "Rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use" was registered by the Ministry of Justice of the Russian Federation only on August 15, 2013 and officially published in Rossiyskaya newspaper N 190 August 28, 2013.
In accordance with paragraph 12 of Decree of the President of the Russian Federation dated May 23, 1996 N 763 “On the procedure for publication and entry into force of acts of the President of the Russian Federation, the Government of the Russian Federation and regulatory legal acts of federal executive bodies” (as amended on February 2, 2013) this order entered into force ten days after the day of their official publication, i.e. September 8, 2013.
Thus, it was from this date that the obligation of the organizations listed in Part 3 of Article 58.1 of the Law “On the Circulation of Medicines” began to keep records of medicines subject to PCU, according to the rules approved by Order No. 378n.
Ethanol (Ethyl alcohol, Medical antiseptic solution) is included in section 5 “Other medicines” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785 “List of medicines subject to subject-quantitative registration in pharmacies(organizations), drug wholesale trade organizations, medical institutions and private practitioners" (as amended on 08/06/2007), therefore, operations related to the circulation of ethyl alcohol intended for medical use should be taken into account in accordance with the "Rules registration of transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use" and "Rules for maintaining and storing special journals accounting of operations related to the circulation of medicines for medical use" approved by Order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n, including in the industrial pharmacy.

Letter from the Ministry of Health of the Republic of Tatarstan
dated October 21, 2013 N 09-01/11725

Heads of medical organizations independently
from the organizational and legal form, form
property and departmental affiliation
Republic of Tatarstan
Heads of Health Departments
by years Kazan, Naberezhnye Chelny,
Nizhnekamsk, Almetyevsk MZ RT
Heads of pharmaceutical organizations

The Ministry of Health of the Republic of Tatarstan sends you, for guidance in your work, the order of the Ministry of Health of the Republic of Tatarstan dated June 17, 2013 N 378n “On approval of the rules for registering transactions related to the circulation of medicines for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related with the circulation of medicines for medical use, and the rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use" (hereinafter referred to as Order No. 378n). The order came into force on September 8, 2013.
In accordance with the written explanation of the Ministry of Health of the Russian Federation, medical and pharmacy organizations, wholesale trade organizations of medicines, individual entrepreneurs with a license for pharmaceutical activities or a license for medical activities are required to comply with the requirements of this order.
In connection with incoming requests from medical organizations about the procedure for registering and maintaining new logs of operations related to the circulation of medicines for medical use, subject to subject-quantitative accounting (hereinafter referred to as PKU), we inform you as follows.
The list of medicines subject to PCU was approved by order of the Ministry of Health and social development Russian Federation dated December 14, 2005 N 785 “On the procedure for dispensing medicines.”
Please note that from this list the drugs Butorphanol, Teaneptine and 21 potent substances are transferred to List III of psychotropic substances, diethyl ether is transferred to List IV of precursors of the List of narcotic drugs, psychotropic substances and their precursors, approved by the Decree of the Government of the Russian Federation of June 30, 1998 N 681 and require accounting procedures approved for narcotic drugs, psychotropic substances and their precursors.
When drawing up new-style accounting journals approved by Order N 378n, it is necessary to take into account:
- the transfer of the accounting balance of medicinal products subject to PCU from the “old” accounting journals to the new ones is carried out according to an act by a commission, the composition of which is approved by order of the head of the legal entity;
- in the “old” accounting journals the following entry is made: “The journal is completed due to the entry into force of the order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n”);
- unused sheets of “old” accounting journals are crossed out.
Transactions are recorded for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate, expanded sheet of the accounting journal or in a separate accounting journal on paper or in electronic form.
Registration of transactions in accounting journals is carried out by persons authorized by order of the head of the legal entity to maintain and store accounting journals.
Journals filled out on paper are bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity before they begin to be maintained.
It is allowed to keep a logbook in electronic form. In this case, the sheets filled out electronically must:
- print monthly;
- number;
- brochures by name of the drug, dosage, dosage form;
- after the end of the calendar year, the bound sheets are drawn up in a journal, which is sealed indicating the number of sheets and certified by the signatures of the person authorized to maintain and store journals, the head of the legal entity and the seal of the legal entity.
Entries in the accounting journals are made authorized person with a ballpoint pen at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with medicines.
The receipt of a medicinal product is reflected in the accounting journal for each receipt document, indicating the number and date of the document; recording each expense transaction in the accounting journal is not required; in medical organizations, consumption is recorded daily. Pharmacy organizations and individual entrepreneurs also record daily consumption, but separately indicate the prescriptions of doctors and the requirements of medical organizations.
Corrections in the accounting journals are certified by the signature of the person authorized to maintain and store the accounting journals. Erasures and uncertified corrections in accounting journals are not permitted.
On the last day of each month, the person authorized to maintain and store accounting journals checks the actual availability of medicines with their balance in the accounting journal and makes appropriate entries in the accounting journal (columns 12 and 13 are filled in).
The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.
Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.
Completed accounting logs are stored in the archives of the legal entity.
Accounting logs are prepared for the calendar year. As of December 31, 2013, the accounting journal must be completed, with the balance transferred to the accounting journal for 2014.
In order to tighten the accounting or adapt the accounting to the treatment process, additional columns or lines may be added to the forms of journals for recording medicines subject to PCU, approved by Order N 378n. All additions must be approved by order of the head of the legal entity. It is not allowed to exclude columns of accounting journals approved by Order N 378n.
Taking into account the suggestions of medical organizations, we recommend forms of log books for use in senior offices nurses and treatment rooms of departments of medical organizations (Appendices No. 1 and No. 2, additions to the logbook forms are highlighted in bold).
In accordance with paragraph 5 of Art. 58.1 of the Federal Law of April 12, 2010 N 61-FZ (as amended on July 2, 2013) “On the Circulation of Medicines” control over compliance with the rules for registering operations related to the circulation of medicines for medical use included in the list of medicines subject to subject-matter quantitative accounting, in special journals, as well as compliance with the rules for maintaining and storing special journals is carried out within the framework of licensing control.

Appendix No. 1

Journal of transactions related to the circulation of medicines for medical use (head nurse’s office ____________________________________) department name

Balance on the 1st of the month

Total consumption per month

Signature of the authorized person

Received from:

N and document date

Quantity (batch)

date of issue

N medical document(Full name of the patient, requirement of the treatment room)

Quantity

March, etc.

Appendix No. 2

(name of medical organization)

Journal of transactions related to the circulation of medicines for medical use (treatment room ____________________________) department name

Balance on the 1st of the month

Just a month upon arrival with the balance

Total consumption per month

Journal balance at the end of the month

Actual balance at the end of the month

Signature of the authorized person

Balance at the end of the work shift

Received from:

N and document date

Quantity (batch)

date of issue

N of the medical document (full name of the patient,

Quantity

has not entered into force Editorial from 17.06.2013

Name of document	ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO REGISTRATION METHOD-QUANTITATIVE ACCOUNTING, IN SPECIAL JOURNALS FOR ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES DRUGS FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE"
Document type	order
Receiving authority	Ministry of Health of the Russian Federation
Document number	378N
Acceptance date	01.01.1970
Revision date	17.06.2013
Registration number in the Ministry of Justice	29404
Date of registration with the Ministry of Justice	15.08.2013
Status	has not entered into force
Publication	At the time of inclusion in the database, the document was not published
Navigator	Notes

ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO REGISTRATION METHOD-QUANTITATIVE ACCOUNTING, IN SPECIAL JOURNALS FOR ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES DRUGS FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE"

This document comes into force 10 days after the day of its official publication (clause 12 of Decree of the President of the Russian Federation dated May 23, 1996 N 763)

Order

In accordance with paragraph 5.2.171(3) of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collected Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970), I order:

Approve:

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

Minister
V.I. SKVORTSOVA

Applications

Appendix No. 1

Russian Federation
dated June 17, 2013 N 378n

Appendix 1. RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO SUBJECT-QUANTITATIVE RECORDING IN SPECIAL JOURNALS FOUR OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

1. These Rules establish requirements for registration of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting<1>(hereinafter referred to as medicines), as a result of which their quantity and (or) condition changes.

2. Registration of operations related to the circulation of medicines that are narcotic drugs, psychotropic substances or their precursors included in lists III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation<2>, is carried out by subjects of circulation of medicines in special journals according to the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for recording transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 N 644<3>, and an appendix to the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419<4>.

<2>Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8 , Art. 663, Art. 4666; Art. 2007, N. 3439; Art. , Art. 314, Art. 2100, Art. 3035, Art. 3703, Art. 4271, Art. 5864, Art. ; 2011, Art. 1390, Art. 1635, Art. 4473, Art. 5921, Art. , N 11, art. 1295, no. 2400, no. 2864, no. 5002, no. 6686, no. 6861, no. 953).

<3>Collection of legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N37, art. 5002.

<4>Collection of legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

1) manufacturers of medicines and wholesale trade organizations of medicines in the form in accordance with Appendix No. 1 to these Rules;

2) pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;

3) medical organizations and individual entrepreneurs with a license for medical activities, in the form in accordance with Appendix No. 3 to these Rules.

4. Registration of transactions related to the circulation of medicinal products is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the accounting journal or in a separate accounting journal on paper or in electronic form.

5. Registration of transactions related to the circulation of medicines is carried out by persons authorized by the head of a legal entity to maintain and store accounting logs, or by an individual entrepreneur who has a license for pharmaceutical activities or medical activities.

APPENDICES TO THE RULES

Appendix No. 1

medicines for medical use,

Russian Federation
dated June 17, 2013 N 378n

Appendix 1. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month

Balance on the 1st of the month

Coming

Consumption

Total consumption per month

Signature of the authorized person

Received from:

N and document date

Quantity

To whom it was released

N and document date

Quantity

January

February

March

April

May

June, etc.

Appendix No. 2
to the Rules for registering transactions related to circulation
medicines for medical use,
included in the list of medicines for medical
applications subject to subject-quantitative accounting,
in special journals for recording transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 2. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month	Balance on the 1st of the month	Coming		Just a month upon arrival with the balance	Types of consumption	Consumption					Monthly expenses for each type separately	Just a month for all types of expenses	Remainder according to the accounting journal at the end of the month	Actual balance at the end of the month	Signature of the authorized person
Month	Balance on the 1st of the month	Supplier, N and document date	Quantity	Just a month upon arrival with the balance	Types of consumption	1	2	3	4	5, etc.	Monthly expenses for each type separately	Just a month for all types of expenses		Actual balance at the end of the month	Signature of the authorized person
1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16
January					according to prescriptions
January					according to requirements
February etc.					according to prescriptions
February etc.					according to requirements

Appendix No. 3
to the Rules for registering transactions related to circulation
medicines for medical use,
included in the list of medicines for medical
applications subject to subject-quantitative accounting,
in special journals for recording transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 3. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month

Balance on the 1st of the month

Coming

Just a month upon arrival with the balance

Consumption

Total consumption per month

Balance of the accounting journal at the end of the month

Actual balance at the end of the month

Signature of the authorized person

Received from:

N and document date

Quantity

date of issue

N of the medical document (full name of the patient)

Quantity

January

February

March

April

May

June, etc.

Appendix No. 2
to the order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 2. RULES FOR MAINTAINING AND STORING SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

1. These Rules establish requirements for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting<1>(hereinafter referred to as log books, medicines).

<1>Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, N 49, Art. 6409; 2011, Art. 7351; 2012, Art. 3446;

3. The introduction and storage of special logs of transactions related to the circulation of medicinal products, specified in paragraph 2 of these Rules, is carried out in accordance with the Rules for the maintenance and storage of special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by decree of the Government of the Russian Federation dated November 4, 2006 N 644<3>, and the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419<4>.

<3>Collection of legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002.

<4>Collection of legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

Accounting logs are prepared for the calendar year.

5. Sheets of accounting logs filled out electronically are printed out monthly, numbered, signed by a person authorized to maintain and store accounting logs, and bookleted by name of the medicinal product, dosage, and dosage form.

At the end of the calendar year, the bound sheets are drawn up in a journal, sealed with an indication of the number of sheets and certified by the signature of the person authorized to maintain and store accounting journals, the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur).

7. The receipt of the medicine is reflected in the accounting journal for each receipt document separately, indicating the number and date. Drug consumption is recorded daily. Pharmacy organizations and individual entrepreneurs with licenses for pharmaceutical activities record the daily consumption of the drug, indicating separately the prescriptions issued to medical workers and the requirements of medical organizations.

10. The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.

Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.

11. Completed accounting logs are stored in the archives of a legal entity (individual entrepreneur).

The Zakonbase website contains the ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CHANGE OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE ENTITIES SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL ACCOUNTING JOURNALS OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE" in the most latest edition. It is easy to comply with all legal requirements if you read the relevant sections, chapters and articles of this document for 2014. To find the necessary legislative acts on a topic of interest, you should use convenient navigation or advanced search.

On the Zakonbase website you will find the ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CHANGE OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE" CHANGES SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL MAGAZINES ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR ACCOUNTING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE" in a fresh and full version, in which all changes and amendments have been made. This guarantees the relevance and reliability of the information.

At the same time, download the ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CHANGE OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL JOURNALS FOR ACCOUNTING OPERATIONS RELATED “CYCLING OF MEDICINES FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE” is available completely free of charge, both in full and in separate chapters.

Registration N 29404

Approve:

rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

Minister V. Skvortsova

Appendix No. 1 to the Order

1. These Rules establish requirements for registration of transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting 1 (hereinafter referred to as medicinal products), as a result of which their quantity and (or) changes ) state.

2. Registration of transactions related to the circulation of medicinal products that are narcotic drugs, psychotropic substances or their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2 is carried out by the subjects of drug circulation funds in special journals in the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for recording transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 N 644 3, and the appendix to the Rules for maintaining and storage of special logs of registration of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419 4.

1) manufacturers of medicines and wholesale trade organizations of medicines in the form in accordance with Appendix No. 1 to these Rules;

2) pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;

3) medical organizations and individual entrepreneurs with a license for medical activities, in the form in accordance with Appendix No. 3 to these Rules.

2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, Art. 4666; 2007, Art. 3439; Art. 3183, Art. 6572; 3, Art. 314, Art. 2100, Art. 3035, Art. 3703, Art. 4271, Art. 5864, Art. 6720; 2011, Art. 1390, Art. 1635, Art. 4473, Art. 5921, Art. 1232, No. 1295, No. 2400, No. 2864, No. 5002, No. 6686, No. 6861 .953).

Appendix No. 2 to the Order

Rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use

1. These Rules establish requirements for maintaining and storing special logs of transactions related to the circulation of medicines for medical use included in the list of medicines for medical use, subject to subject-quantitative accounting 1 (hereinafter referred to as log books, medicines).

2. These Rules do not apply to the maintenance and storage of special logs of transactions related to the circulation of medicines that are narcotic drugs, psychotropic substances and their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2.

Accounting logs are prepared for the calendar year.

10. The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.

Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.

11. Completed accounting logs are stored in the archives of a legal entity (individual entrepreneur).

1 Article 58.1 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, N 49, art. 6409; 2011, art. 7351;

2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collection of Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, N 47, Art. 4666; 2006, N 29, Art. 3253; 2007, Art. 3439; , N 28, Art. 3703, Art. 4271, Art. 5864, Art. 6720; 29, art. 4473, no. 5921, no. 7534; 2012, no. 1232, no. Art. 2864, No. 37, Art. 48, No. 6686, Art. 2013, No. 953).

3 Collection of Legislation of the Russian Federation, 2006, No. 46, Art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002.

4 Collection of Legislation of the Russian Federation, 2010, No. 25, Art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

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