Legislative base of the Russian Federation. Subject quantitative accounting Order 378 n dated 17.06 13

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

Edition of 04/05/2018 - Valid from 05/14/2018

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MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated June 17, 2013 N 378n

On the approval of the rules for registering operations related to the treatment of drugs for medical use, included in the list of drugs for medical use subject to subjective and accounting, in special journals of accounting for operations related to the treatment of medicines for medical use, and the rules of maintenance and storage OF SPECIAL JOURNALS OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

(As amended by the Orders of the Ministry of Health of the Russian Federation dated October 31, 2017 N 882n, dated April 5, 2018 N 149n)

Approve:

rules 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 in special registers for registering transactions related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;

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

Minister
IN AND. SKVORTSOVA

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

<2>Decree of the Government of the Russian Federation of June 30, 1998 N 681 "On approval of the list drugs, psychotropic substances and their precursors subject to control in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, N 27, item 3198; 2004, N 8, item 663; N 47, item 4666; 2006, N 29, item 3253; 2007, N 28, item 3439; 2009, N 26, item 3183; N 52, item 6572; 2010, N 3, item 314; N 17, item 2100; N 24, item 3035; N 28 3703; N 31, item 4271; N 45, item 5864; N 50, item 6696, item 6720; 2011, N 10, item 1390; N 12, item 1635; N 29, item 4466, item 4473; N 42, item 5921; N 51, item 7534; 2012, N 10, item 1232; N 11, item 1295; N 19, item 2400; N 22, item 2864 ; N 37, item 5002; N 48, item 6686; N 49, item 6861; 2013, N 9, item 953; N 25, item 3159; N 29, item 3962; N 37, item 4706; N 46, item 5943; N 51, item 6869; 2014, N 14, item 1626; N 23, item 2987; N 27, item 3763; N 44, item 6068; N 51, item 7430; 2015, N 11, item 1593; N 16, item 2368; N 20, item 2914; N 28, item 4232; N 42, item 5805; 2016, N 15, item 2088; 2017 , N 4, item 671, N 10, item 1481, N 23, item 3330; N 30, item 4664; N 33, item 5182). (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)

<3>Collection of Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, No. 30, Art. 3033; 2003, N 2, Art. 167; No. 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; No. 48, Art. 5515; No. 52, art. 6233; 2009, N 29, art. 3588, 3614; 2010, No. 21, art. 2525; N 31, art. 4192; 2011, N 1, art. 16, art. 29; No. 15, Art. 2039; No. 25, Art. 3532; No. 49, Art. 7019, Art. 7061; 2012, N 10, art. 1166; No. 53, art. 7630; 2013, N 23, art. 2878; No. 30, Art. 4057; No. 48, art. 6161, Art. 6165; 2014, N 23, Art. 2930; 2015, N 1, art. 54; No. 6, Art. 885; No. 29, Art. 4388; 2016, N 1, art. 28; No. 15, art. 2052; No. 27, Art. 4160; Art. 4238. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)

<4>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; 2013, N 6, art. 558, N 51, art. 6869; 2015, N 33, Art. 4837; 2017, N 2, art. 375. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)

<5>Collection of Legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, no. 41, art. 5623, No. 51, art. 7235; 2015, N 33, art. 4837; 2017, N 2, art. 375. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 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 ledgers for registering transactions related to the circulation of medicines (hereinafter referred to as registers):

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

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

3) medical organizations and individual entrepreneurs licensed 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 register or in a separate register 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 legal entity for the maintenance and storage of accounting journals, or by an individual entrepreneur who has a license for pharmaceutical activities or for medical activities.

________

Appendix No. 2





medicines for medical use,

Russian Federation
dated June 17, 2013 N 378n

JOURNAL OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE
(name of medicinal product for medical use)
____________________________________________________________________________
(dosage, dosage form, unit of measurement)

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 accounting for transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

JOURNAL OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE
__________________________________________________________________________
(name of medicinal product for medical use)
__________________________________________________________________________
(dosage, dosage form, unit of measure)

(As amended by the Order of the Ministry of Health of the Russian Federation of October 31, 2017 N 882n)

Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378n "On approval of the rules for registering transactions related to the circulation of medicines for medical use included in the list of medicines for medical use subject to subject-quantitative accounting, in special registers for registering transactions related to with the circulation of medicinal products for medical use, and the rules for maintaining and storing special registers of transactions related to the circulation of medicinal products for medical use" (with amendments and additions)

Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378n
"On Approval of the Rules for Registration of Operations Related to the Circulation of Medicinal Products for Medical Use, Included in the List of Medicinal Products for Medical Use Subject to Quantitative Accounting, in Special Registers of Operations Related to the Circulation of Medicinal Products for Medical Use, and the Rules for Maintaining and storage of special registers of transactions related to the circulation of medicines for medical use"

With changes and additions from:

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

Registration N 29404

The rules for registration in special registers of transactions related to the circulation of medicines included in the list of medicines for medical use subject to subject-quantitative accounting have been approved.

It sets out the requirements for registering operations that are related to the circulation of medicines and as a result of which their number and (or) state changes.

These operations are registered by drug manufacturers and wholesalers, pharmacy / medical organizations and individual entrepreneurs licensed for pharmaceutical / medical activities. The forms of the corresponding journals are given.

Registration 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 register or in a separate journal on paper or in electronic form.

Registration is carried out by persons authorized by the head of the legal entity to maintain and store accounting journals, or individual entrepreneurs who have a license for pharmaceutical / medical activities.

In addition, the rules for maintaining and storing special registers of transactions related to the circulation of medicines for medical use are fixed.

Separate attention is paid to the registration of operations related to the circulation of drugs that are included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in our country.

Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378n "On approval of the rules for registering transactions related to the circulation of medicines for medical use included in the list of medicines for medical use subject to subject-quantitative accounting, in special registers for registering transactions related to with the circulation of medicinal products for medical use, and the rules for maintaining and storing special registers of transactions related to the circulation of medicinal products for medical use"

Clause 4 of Appendix 1 of Order 378n: registration of transactions related to the circulation of medicines is carried out for each trade name (for each individual dosage and dosage form) on a separate expanded sheet of the register or in a separate register on paper or in electronic form.

Violation example 3.
According to the magazine of the wholesale distribution department for the medicinal product with the international non-proprietary name "Ethanol (Ethyl alcohol) 95%" at the time of verification, the actual balance as of the 1st day of the month (December 1, 2017) for the trade name "Ethanol (Ethyl alcohol) 95% - 100 ml "was 0 pack. In fact, there were packages available (14 packs). The available packages, according to the explanation of the person in charge, were taken into account in the section of the magazine "Ethanol (Ethyl alcohol) 95%, gr" - angro.

Representatives of the organization, in support of their position, explained that in the wholesale department "Ethanol" (Ethyl alcohol) 95% is dispensed on demand medical organization and for the manufacture of extemporaneous dosage forms, and this drug is taken into account in various units of measurement. For dispensing according to the requirements of a medical organization, it is taken into account in vials, indicating the number of vials. For the manufacture of extemporaneous dosage forms, accounting is kept in grams (receipt according to invoices from suppliers and consumption according to invoice requirements of a medical organization and prescriptions are transferred from milliliters to grams in accordance with Appendix No. 9, Table No. 1 of Order No. 751n. 100 ml of the drug "Ethanol ( Ethyl alcohol) 95% corresponds to 81.14 grams Separate pages are allocated for the drug with the international non-proprietary name "Ethanol (Ethyl alcohol) 95%" in the register of the wholesale sales department.

Based on the foregoing, the company believes that it did not violate clause 4 of the Rules for registering transactions, and clause 7 of the Rules for maintaining and storing special journals of transactions, (appendices 1 and 2 of order 378n).

The court, assessing the totality and interrelationship of the submitted audit materials, the arguments of the parties, found that the accounting of the same type of product with the international non-proprietary name "Ethanol (ethyl alcohol) 95%" was carried out both in vials and in grams on separate sheets of the journal . At the same time, when resolving the dispute in this part, the court concludes that this accounting procedure does not comply with the current Registration Rules.

According to clause 4 of the Rules for registering transactions, registration of transactions related to the circulation of medicines 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 register or in a separate register on paper or in electronic form. form. In this case, the log indicates the unit of measurement.

The accounting procedure that the organization maintains (in different units of measurement on separate sheets of the accounting log for the same lot of the medicinal product) can lead to discrepancies and inconsistencies in accounting. According to the accounting, which is kept in milliliters (vials), the drug is not available (according to the journal as of 01.12.2017 - 0 packs), while in fact the drug, if taken into account in grams, is not used up (available) 2084.45 g. 12/01/2017, which is reflected in the log.

Violation example 4.
According to the journal of the wholesale distribution department for a medicinal product with the international non-proprietary name "Ethanol (Ethyl alcohol) 70% -100 ml", joint summary records were kept for several incoming trade names.

The receipt of various trade names is confirmed by the consignment note dated 10/09/2017 (trade name "Ethyl alcohol solution for external use 70% 100 ml, manufacturer Rosbio LLC", Russia), the consignment note dated 10/09/2017 (trade name "Ethyl alcohol solution external use 70% 100 ml, manufacturer Rosbio LLC, Russia"), invoice dated 07/28/2017 (trade name "Ethyl alcohol solution for external use and preparation of dosage forms 70% 100 ml, manufacturer PHC Medkhimprom OJSC", Russia”), a delivery note dated 06/30/2017 (trade name “Ethyl alcohol solution for external use and preparation of dosage forms 70% 100 ml, manufactured by Hippocrat LLC, Russia”).

The organization, without disputing this fact, at the same time believes that since the medicinal product has one trade name, one dosage form, one dosage, registration of transactions on one separate expanded sheet of the register does not indicate a violation of clause 4 of the Rules for registering transactions related to circulation medicines for medical use.

The court, when resolving the dispute in the specified part of the objection of the company, recognizes it as justified. It follows from the content of clause 4 of the Registration Rules that registration is carried out for each trade name of the medicinal product (for each separate dosage and dosage form). Since we are talking about one trade name "Ethyl alcohol solution for external use and preparation of LF 70% 100 ml", there is no reason to believe that the account was kept for several trade names. The fact that the goods were supplied by different manufacturers does not indicate the different trade names of the supplied goods.

Clause 5 of Appendix 1 of Order No. 378n, registration of transactions related to the circulation of medicines is carried out by persons authorized by the head of the legal entity (not the head of the pharmacy, but the head of the legal entity!) for the maintenance and storage of accounting journals, or by an individual entrepreneur who has a license for pharmaceutical activities or for medical activities.

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

Heads of medical organizations regardless
from the organizational and legal form, form
ownership and departmental affiliation
Republic of Tatarstan
Heads of Health Departments
by years Kazan, Naberezhnye Chelny,
Nizhnekamsk, Almetievsk Ministry of Health of the Republic of Tatarstan
Heads of pharmaceutical organizations

The Ministry of Health of the Republic of Tatarstan sends you for guidance in the 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 registers of transactions related to with the circulation of medicinal products for medical use, and the rules for maintaining and storing special registers of transactions related to the circulation of medicinal products for medical use" (hereinafter - Order N 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, drug wholesalers, individual entrepreneurs holding 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 on the procedure for issuing and maintaining new registers of transactions related to the circulation of medicines for medical use subject to subject-quantitative accounting (hereinafter referred to as PKU), we report the following.
The list of medicines subject to PKU was approved by order of the Ministry of Health and Social Development of the Russian Federation of 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 were transferred to List III of psychotropic substances, Diethyl ether was transferred to List IV of the precursors of the List of narcotic drugs, psychotropic substances and their precursors, approved by the Decree of the Government of the Russian Federation of 06/30/1998 N 681 and require the accounting procedure approved for narcotic drugs, psychotropic substances and their precursors.
When issuing new-style accounting journals approved by order N 378n, it is necessary to take into account:
- balance transfer medicines, subject to PKU, from the "old" accounting journals to the new ones is carried out according to the act by the commission, the composition of which is approved by order of the head of the legal entity;
- in the "old" registers, an entry is made: "The journal is completed, in connection with 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" registers are crossed out.
Registration of transactions 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 register or in a separate register on paper or in electronic form.
Registration of operations in accounting journals is carried out by persons authorized by order of the head of the legal entity to maintain and store accounting journals.
Magazines 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 are kept.
It is allowed to keep a record book in electronic form. In this case, the sheets filled in electronically must be:
- monthly print;
- to number;
- Brochure on the names of the medicinal product, dosage, dosage form;
- after the expiration of the calendar year, the bound sheets should be drawn up in a journal, which is sealed with an indication of the number of sheets and certified by the signatures of the person authorized to maintain and store the journals, the head of the legal entity and the seal of the legal entity.
Entries in the registers are made by an 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 register for each receipt document, indicating the number and date of the document, each expenditure operation is not required to be recorded in the register, in medical organizations the expense is recorded daily. Pharmacy organizations and individual entrepreneurs also record daily consumption, but with indication separately according to doctors' prescriptions and according to 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 allowed.
On the last day of each month, the person authorized to maintain and store the registers checks the actual availability of medicines with their balance in the register and makes the appropriate entries in the register (columns 12 and 13 are filled in).
The accounting log is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting log.
Receipt and expenditure documents (their copies) are filed in the order of their receipt by date and are stored together with the accounting journal.
Completed accounting books are stored in the archive of the legal entity.
Accounting journals are issued for the calendar year. On December 31, 2013, the accounting journal must be completed, with the transfer of the balance to the accounting journal for 2014.
Additional columns or lines may be added to the forms of registers of medicines subject to PKU, approved by Order N 378n, in order to tighten accounting or adapt accounting to the medical process. All additions must be approved by order of the head of the legal entity. It is not allowed to exclude the columns of the accounting journals approved by order N 378n.
Taking into account the proposals of medical organizations, we recommend forms of registers for use in the offices of senior nurses and treatment rooms of departments of medical organizations (Appendices No. 1 and No. 2, additions to the forms of the register are in bold).
In accordance with paragraph 5 of Art. 58.1 of the Federal Law of 12.04.2010 N 61-FZ (as amended on 02.07.2013) "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- 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 license control.

Appendix No. 1

Appendix No. 1

Register of operations related to the circulation of medicines for medical use (head nurse's office ____________________________________) name of the department

Appendix No. 2

Appendix No. 2

(name of medical organization)

Register of operations related to the circulation of medicinal products for medical use (treatment room ____________________________) name of the department