"On approval of the rules for registering operations related to the appeal medicines for medical applicationincluded in the list of medicines for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical applications, and rules for conducting and storing special operations of operations related to the appeal of medicines for medical use "

The editors of April 05, 2018 - is valid from 05/14/2018

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Ministry of Health of the Russian Federation

ORDER
dated June 17, 2013 N 378n

On approval of the regulations for registration of operations related to the appeal of medicines for medical use included in the list of drugs for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical applications, and regulations and storage Special Magazines Accounting Operations related to the appeal of medicines for medical use

(as amended by orders of the Ministry of Health of the Russian Federation of 31.10.2017 N 882n, from 04/05/2018 N 149n)

Approve:

rules for the registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special journals for accounting operations related to the treatment of medicines for medical use, according to Appendix N 1;

rules for maintaining and storing special accounting logs related to the appeal of medicines for medical use, according to Appendix N 2.

Minister
IN AND. Skvortsova

1. These Rules establish the requirements for registration of operations related to the appeal of medicines for medical use included in the list of medicines for medical use to be subject to commercial accounting<1> (hereinafter - drugs), as a result of which their number and (or) condition changes.

<2> Decree of Government Russian Federation dated June 30, 1998 N 681 "On approval of a list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation" (Meeting of the 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, N 28, Art. 3439; 2009, N 26, Art. 3183; N 52, Art. 6572; 2010, N 3, Art. 314 ; N 17, Art. 2100; N 24, Art. 3035; N 28, Art. 3703; N 31, Art. 4271; N 45, Art. 5864; N 50, Art. 6696, Art. 6720; 2011, n 10, Art. 1390; N 12, Art. 1635; N 29, Art. 4466, Art. 4473; N 42, Art. 5921; N 51, Art. 7534; 2012, N 10, Art. 1232; N 11, Article 1295; N 19, Art. 2400; N 22, Art. 2864; N 37, Art. 5002; N 48, Art. 6686; N 49, Art. 6861; 2013, N 9, Art. 953; N 25 , Art. 3159; N 29, Art. 3962; N 37, Art. 4706; N 46, Art. 5943; N 51, Art. 6869; 2014, N 14, Art. 1626; N 23, Art. 2987; n 27, Art. 3763; N 44, Art. 6068; N 51, Art. 7430; 2015, N 11, Art. 1593; N 16, Art. 2368; N 20, Art. 2914; N 28, 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). (as amended by the order of the Ministry of Health of the Russian Federation of 05.04.2018 N 149n)

<3> Meeting of the legislation of the Russian Federation, 1998, N 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; Art. 4238. (as amended by the order of the Ministry of Health of the Russian Federation of 05.04.2018 N 149n)

<4> Meeting of the 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 05.04.2018 N 149n)

<5> Meeting of the 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; 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 05.04.2018 N 149n)

3. Registration of drug-related operations (with the exception of drugs specified in paragraph 2 of these Rules) is carried out in special journals for accounting operations related to the appeal of drugs (hereinafter - accounting logs):

1) drug producers and wholesale organizations by drugs in form in accordance with Appendix N 1 to this Regulation;

2) pharmaceutical organizations and individual entrepreneurs who have a license for pharmaceutical activities in form in accordance with Appendix N 2 to these Regulations;

3) medical organizations and individual entrepreneurs who have a license for medical activities in form in accordance with Appendix No. 3 to this Regulation.

4. Registration of drug-related operations is carried out for each trading name of the drug (for each separate dosage and dosage form) on a separate deployed sheet of accounting log or in a separate accounting log on paper or electronically.

5. Registration of transactions related to the appeal of drugs are carried out by persons authorized by the head legal entity For keeping and storing accounting logs, or an individual entrepreneur licensed for pharmaceutical activities or for medical activities.

________

Appendix N 2.





medicines for medical use,

Russian Federation
dated June 17, 2013 N 378n

Journal of Accounting Operations related to the appeal of medicines for medical use
(Drug Name for Medical Applications)
____________________________________________________________________________
(dosage, dosage form, unit)

Appendix N 3.
to the rules for registering operations related to the appeal
medicines for medical use,
included in the list of medicines for medical
applications subject to subject and quantitative accounting,
in special accounting journals related to the appeal
medicines for medical use,
approved by the order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Journal of Accounting Operations related to the appeal of medicines for medical use
__________________________________________________________________________
(Drug Name for Medical Applications)
__________________________________________________________________________
(Dosage, Dosage Form, Unit of Measurement)

(as amended by the order of the Ministry of Health of the Russian Federation of 31.10.2017 N 882n)

Registration N 29404.

In accordance with clause 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 (Meeting of the Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970), order:

Approve:

rules for the registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special journals for accounting operations related to the treatment of medicines for medical use, according to Appendix N 1;

rules for maintaining and storing special accounting logs related to the appeal of medicines for medical use, according to Appendix N 2.

Minister V. Skvortsova

Appendix N 1 to the orders

Rules for the registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical use

1. These Rules establish the requirements for registration of operations related to the appeal of medicines for medical use included in the list of drugs for medical use to be subject to subject-quantitative accounting 1 (hereinafter - drugs), resulting in their number and (or ) state.

2. Registration of operations related to the treatment of drugs that are narcotic drugs, psychotropic substances or their precursors included in the lists II, III, IV list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation 2 is carried out by the subjects of drug circulation Funds in special journals for the forms provided for by Appendix N 1 to the rules of conducting and storing special journals for registration of operations related to drug trafficking and psychotropic substances, approved by the Decree of the Government of the Russian Federation of November 4, 2006 N 644 3, and the application to the rules of reference and storing special journals for registration of operations related to the turnover of precursors of narcotic drugs and psychotropic substances approved by the Decree of the Government of the Russian Federation of June 9, 2010 N 419 4.

3. Registration of drug-related operations (with the exception of drugs specified in paragraph 2 of these Rules) is carried out in special journals for accounting operations related to the appeal of drugs (hereinafter - accounting logs):

1) drug producers and wholesale organizations by drugs in form in accordance with Appendix N 1 to this Regulation;

2) pharmaceutical organizations and individual entrepreneurs who have a license for pharmaceutical activities in form in accordance with Appendix N 2 to these Regulations;

3) medical organizations and individual entrepreneurs who have a license for medical activities in form in accordance with Appendix N 3 to this Regulation.

4. Registration of drug-related operations is carried out for each trading name of the drug (for each separate dosage and dosage form) on a separate deployed sheet of accounting log or in a separate accounting log on paper or electronically.

5. Registration of drug-related operations is carried out by persons authorized by the head of a legal entity for maintaining and storing accounting magazines, or an individual entrepreneur who has a license for pharmaceutical activities or for medical activities.

2 Resolution of the Government of the Russian Federation of June 30, 1998 N 681 "On approval of a list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation" (Meeting of the 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, N 28, Art. 3439; 2009, N 26, Art. 3183, N 52, Art. 6572; 2010, n 3, Art. 314, N 17, Art. 2100, N 24, Art. 3035, N 28, Art. 3703, N 31, Art. 4271, N 45, Art. 5864, N 50, Art. 6696, Art. 6720; 2011, N 10, Art. 1390, N 12, Art. 1635, N 29, Art. 4466, Art. 4473, N 42, Art. 5921, N 51, Art. 7534; 2012, N 10, Art. 1232, N 11, Art. 1295, N 19, Art. 2400, N 22, Art. 2864, N 37, Art. 5002, N 48, Art. 6686, N 49, Art. 6861; 2013, N 9, st . 953).

Appendix N 2 to the order

Rules for maintaining and storing special operations of operations related to the treatment of medicines for medical use

1. These Rules establish the requirements for the conduct and storage of special accounting journals related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting 1 (hereinafter referred to as the accounting magazines, drugs).

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

3. The introduction and storage of special journals for accounting operations related to the appeal of the drugs specified in paragraph 2 of these Rules are carried out in accordance with the rules of conducting and storing special logs of registration of operations related to the turnover of narcotic drugs and psychotropic substances, approved by the Government Decree of the Russian Federation. On November 4, 2006, N 644 3, and the rules for the conducting and storage of special journals for registration of operations related to the turnover of drug precursors and psychotropic substances, approved by the Decree of the Government of the Russian Federation of June 9, 2010 N 419 4.

4. Accounting magazines filled on paper, will be dropped, are numbered and fastened by the signature of the head of the legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur) before the start of their maintenance.

Accounting magazines are executed on the calendar year.

5. Sheets of accounting magazines filled in electronic form are printed monthly, numbered, signed by the person authorized to keep and storing accounting logs, and put on the names of the drug, dosage, dosage form.

Upon the expiration of the calendar year, the discarded sheets are issued into the magazine, sealed with the number of sheets and are certified by the signature of the person authorized to conduct and storing accounting magazines, the head of the legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur).

6. Records in accounting magazines are made by a person authorized to keep and storing the accounting magazine, a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the arrival and drug-expenditure operations.

7. Receipt of the medicinal product is reflected in the accounting log for each receipt document separately with the number and date. Drug consumption is written daily. Pharmacy organizations and individual entrepreneurs who have licenses for pharmaceutical activities record daily drug consumption indicating separately by recipes written by medical professionals, and according to the requirements of medical organizations.

8. Corrections in accounting magazines are assigned by the signature of the person authorized to keep and storing accounting logs. Susks and incomplete corrections in accounting magazines are not allowed.

9. For the last number of each month, the person authorized for the maintenance and storage of accounting magazines conducts reconciliation of the actual presence of medicines with their balance on the account log and makes relevant records in the accounting log.

10. Accounting magazine is stored in a metal cabinet (safe), the keys from which are at the person authorized to keep and storing the accounting magazine.

Parishes and expenditure documents (their copies) are mounted in the order of their receipts by dates and are stored together with the accounting magazine.

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

1 Article 58.1 Federal Law dated April 12, 2010 N 61-FZ "On the circulation of medicines" (meeting of the 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 Resolution of the Government of the Russian Federation of June 30, 1998 N 681 (Meeting of the legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, N 47, Art. 4666; 2006, N 29, 3253; 2007, N 28, Art. 3439; 2009, N 26, Art. 3183, N 52, Art. 6572; 2010, N 3, Art. 314, N 17, Art. 2100, N 24, Art. 3035 , N 28, Art. 3703, N 31, Art. 4271, N 45, Art. 5864, N 50, Art. 6696, Art. 6720; 2011, N 10, Art. 1390, N 12, Art. 1635, N 29, Art. 4466, Art. 4473, N 42, Art. 5921, N 51, Art. 7534; 2012, N 10, Art. 1232, N 11, Art. 1295, N 19, Art. 2400, N 22, Art. 2864, N 37, Art. 5002, N 48, Art. 6686, N 49, Art. 6861; 2013, N 9, Art. 953).

3 Meeting of the 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 Meeting of the 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.

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

Heads of medical organizations independently
from organizational and legal form, forms
property and departmental affiliation
Republic of Tatarstan
Head of Health Office
on gg Kazan, Naberezhnye Chelny
Nizhnekamsk, Almetyevsk MZ RT
Leaders of pharmaceutical organizations

The Ministry of Health of the Republic of Tatarstan sends you to leadership in the work of the Ministry of Health of the Republic of Tatarstan from June 17, 2013 N 378n "On approval of the rules for registering operations related to the treatment of medicines for medical applications to be subject to commercial accounting in special accounting journals related With the appeal of medicines for medical applications, and rules for conducting and storing special operations of operations related to the appeal of medicines for medical use "(hereinafter referred to as the order N 378H). The order came into force on 09/08/2013.
In accordance with the written explanation of the Ministry of Health of the Russian Federation, medical and pharmacy organizations, organizations of the wholesale trade of drugs, individual entrepreneurs who have a license for pharmaceutical activities or a license for medical activities are required to fulfill the requirements of the specified order.
In connection with the incoming requests from medical organizations on the procedure for registration and maintaining new regulations for the accounting of operations related to the appeal of medicines for medical use to be subject to subject-quantitative accounting (hereinafter - PKU), we inform the following.
The list of drugs subject to PKU approved by order of the Ministry of Health and Social Development of the Russian Federation of 14.12.2005 No. 785 "On the procedure for drug leave".
Please note that from this list of drugs Buturofanol, Teanptin and 21 powerful substance Translated into the list of psychotropic substances, diethyl ether translated into the list of IV precursors 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 procedure for accounting approved for narcotic drugs, psychotropic substances and their precursors .
When making logs of a new sample, approved by order N 378N, it is necessary to consider:
- transfer of account balance medicinal preparationssubject to PKU, from the "old" magazines in records in new ones is carried out under the commission of the commission, the composition of which is approved by the order of the head of the legal entity;
- In the "old" record journals, an entry is recorded: "The magazine is completed, in connection with the entry into force of the Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378N);
- Unused sheets of "old" accounting magazines are forth.
Registration of operations is carried out on each trading name of the drug (for each separate dosage and dosage form) on a separate deployed sheet of accounting log or in a separate accounting log on paper or electronically.
Registration of operations in accounting magazines is carried out by persons authorized by the order by the head of a legal entity for maintaining and storing accounting logs.
Magazines filled on paper, will be dropped, are numbered and fastened by the signature of the head of the legal entity and the seal of a legal entity before the start of their maintenance.
Allowed maintenance logging in electronic form. In this case, the sheets are filled in electronic form necessary:
- Print monthly;
- to numbered;
- bind by the names of the drug, dosage, dosage form;
- After the calendar year expires, the discarded sheets are issued in a journal, which is sealed with the number of sheets and is certified by the authorized and storage of facial journals, the head of the legal entity and the seal of a legal entity.
Entries in accounting magazines are made by an authorized face with a ballpoint handle at the end of the working day on the basis of documents confirming the arrival and expenditure operations with drugs.
The receipt of the drug is reflected in the account journal for each receipt document, indicating the number and date of the document, the reflection in the accounting journal of each expenditure operation is not required, in medical organizations, consumption is recorded daily. Pharmacy organizations and individual entrepreneurs also record daily expenses, but indicating the recipes of doctors and according to the requirements of medical organizations.
Corrections in accounting magazines are certified by the signature of the person authorized to keep and storing accounting logs. Susks and incomplete corrections in accounting magazines are not allowed.
For the last number of each month, the person authorized to keep and storing accounting logs conducts reconciliation of the actual presence of medicines with their balance on the account log and makes the appropriate records in the accounting log (graphs 12 and 13) are filled.
The accounting magazine is stored in a metal cabinet (safe), whose keys are at the person authorized to keep and storing the accounting magazine.
Parishes and expenditure documents (their copies) are mounted in the order of their receipts by dates and are stored together with the accounting magazine.
Filled accounting logs are stored in the archive of a legal entity.
Accounting magazines are executed on the calendar year. On December 31, 2013, the accounting log must be completed, with the transfer of the account of the account for 2014.
In accordance with the order of N 378n, the forms of drug accounting logs of drugs to be paid, in order to tighten the accounting or adaptation of accounting for therapeutic process, additional graphs or lines may be made. All additions should be approved by order of the head of the legal entity. Exclude, approved by order N 378N count of accounting logs, is not permitted.
Taking into account the proposals of medical organizations, we recommend the forms of accounting magazines for use in the cabinets of senior nurses and procedural offices of medical organizations (applications N 1 and N 2, supplements in the forms of accounting log are highlighted in bold).
In accordance with paragraph 5 of Art. 58.1 of the Federal Law of 12.04.2010 N 61-FZ (ed. Dated 07/02/2013) "On the circulation of medicines" Control over compliance with the rules for registering operations related to the treatment of medicines for medical use included in the list of drugs subject to items Quantitative accounting, in special journals, as well as in compliance with the rules of conducting and storing special journals, is carried out under license control.

Appendix N 1.

Appendix N 1.

Journal of accounting of operations related to the appeal of medicines for medical use (Cabinet of senior nurse ________________________________)

Appendix N 2.

Appendix N 2.

(Name of the medical organization)

Journal of accounting of operations related to the appeal of medicines for medical use (procedural account ____________________________)

Ministry of Health of the Russian Federation

ORDER

On approval of the regulations for registration of operations related to the appeal of medicines for medical use included in the list of drugs for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical applications, and regulations and storage Special Magazines Accounting Operations related to the appeal 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, 09.01.2018, 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, the Regulations on the Ministry of Health of the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Meeting of the Legislation of the Russian Federation, 2012, N 26, Article 3526; 2013, N 16, Article 1970) .

order:

Approve:

rules for the registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special journals for accounting operations related to the treatment of medicines for medical use, according to Appendix N 1;

rules for maintaining and storing special accounting logs related to the appeal of medicines for medical use, according to Appendix N 2.

Minister
V.Skvortsova

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

Appendix N 1. Rules for the registration of operations related to the appeal of medicines for medical use included in the list of medicines for medical use to be subject to subject-quantitative accounting, ...

Appendix N 1.
to order

Rules for the registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical use

1. These Rules establish the requirements for registration of operations related to the appeal of drugs for medical use included in the list of medicines for medical use to be subject to subject-quantitative accounting (hereinafter - drugs), as a result of which their number and (or) state.
________________

2. Registration of operations related to the appeal of drugs containing narcotic drugs, psychotropic substances and their precursors and included in the lists II, III, IV List of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, as well as combined drugs other pharmacologically active substances and their precursors other than narcotic drugs, psychotropic substances and their precursors, in accordance with control measures, similar to those established against narcotic drugs, psychotropic substances and their precursors contained in them are carried out by subjects of circulation drugs in special magazines in the forms provided for by Appendix N 1 to the rules for the conduct and storage of special logs of registration of operations related to the turnover of narcotic drugs and psychotropic substances approved by the Decree of the Government of the Russian Federation from 4 November 2006, N 644, and the annex to the rules for conducting and storing special logs of registration of operations related to the turnover of drug precursors and psychotropic substances, approved by the Decree of the Government of the Russian Federation of June 9, 2010 N 419.
(The point in the editorial office entered into force from May 14, 2018 by order of the Ministry of Health of Russia dated April 5, 2018 N 149n.
________________

Resolution of the Government of the Russian Federation dated June 30, 1998 N 681 "On approval of a list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation" (Meeting of the legislation of the Russian Federation, 1998, N 27, Article 3198; 2004, N 8 , Article 663; N 47, Article 4666; 2006, N 29, Article.3253; 2007, N 28, Article 3439; 2009, N 26, Article.3183; N 52, Article 6572; 2010, N 3 , st.314; n 17, st.2100; N 24, st.3035; N 28, st.3703; N 31, Article 4271; N 45, Article 5864; N 50, Article.6696, Article.6720 ; 2011, N 10, Article 1390; N 12, Article 1635; N 29, Article 4466, Article 4473; N 42, Article 5921; N 51, Article 7534; 2012, N 10, Article 1232 ; N 11, Article 1295; N 19, Article.2400; N 22, Article 2864; N 37, Article 5002; N 48, Article 6686; N 49, Article 6861; 2013, N 9, Art. 953; N 25, Article.3159; N 29, Article 3962; N 37, Article 4,06; N 46, Article.5943; N 51, Article 6869; 2014, N 14, Article 1626; N 23, .2987; N 27, st.3763; N 44, Article.6068; N 51, Article 7430; 2015, N 11, Article 1593; N 16, st.2368; N 20, st.2914; N 28, Article 4232; N 42, Article 5805; 2016, N 15, Article 2088; 2017, N 4, Article.671, N 10, Article 1481, N 23, Article.3330; N 30, Article 4664; N 33, Art. 5182).
Order of the Ministry of Health of Russia of April 5, 2018 N 149n.

Meeting of the legislation of the Russian Federation, 1998, N 2, Article 279; 2002, N 30, Article.3033; 2003, N 2, Article 167; N 27, Article 2700; 2004, N 49, Art.4845; 2005, N 19, Article 1752; 2006, N 43, Article 4412; N 44, Art.4535; 2007, N 30, Art.3748; N 31, Article 4011; 2008, N 30, Art.3592; N 48, Art.5515; N 52, Article.6233; 2009, N 29, Article 3588, 3614; 2010, N 21, st.2525; N 31, Article 4192; 2011, N 1, Article 16, Article.29; N 15, st.2039; N 25, Art.3532; N 49, Article 7019, Article 7061; 2012, N 10, Art.1166; N 53, Article 7630; 2013, N 23, st.2878; N 30, Article 4057; N 48, Article 6161, Article.6165; 2014, N 23, Article 2630; 2015, N 1, Art. 54; N 6, Article 885; N 29, st.4388; 2016, N 1, Article 28; N 15, st.2052; N 27, Article 4160; Article 4238.
(Footnote in the editorial office introduced from May 14, 2018 by order of the Ministry of Health of Russia of April 5, 2018 N 149n.

Meeting of the legislation of the Russian Federation, 2006, N 46, Article 4795; 2008, N 50, Art. 5946; 2010, N 25, Art.3178; 2012, N 37, Art. 5002; 2013, N 6, Article.558, N 51, Article.6869; 2015, N 33, Art.4837; 2017, N 2, Art.375.
(Footnote in the editorial office introduced from May 14, 2018 by order of the Ministry of Health of Russia of April 5, 2018 N 149n.

Meeting of the legislation of the Russian Federation, 2010, N 25, Article 3178; 2011, N 51, Article 7534; 2012, N 1, Article 1930, N 41, Art. 5623, N 51, Article.7235; 2015, N 33, Art.4837; 2017, N 2, Art.375.
Order of the Ministry of Health of Russia of April 5, 2018 N 149n)

3. Registration of drug-related operations (with the exception of drugs specified in paragraph 2 of these Rules) is carried out in special journals for accounting operations related to the appeal of drugs (hereinafter - accounting logs):

1) drug producers and wholesale organizations by drugs in form in accordance with Appendix N 1 to this Regulation;

2) pharmaceutical organizations and individual entrepreneurs who have a license for pharmaceutical activities in form in accordance with Appendix N 2 to these Regulations;

3) medical organizations and individual entrepreneurs who have a license for medical activities in form in accordance with Appendix N 3 to this Regulation.

4. Registration of drug-related operations is carried out for each trading name of the drug (for each separate dosage and dosage form) on a separate deployed sheet of accounting log or in a separate accounting log on paper or electronically.

5. Registration of drug-related operations is carried out by persons authorized by the head of a legal entity for maintaining and storing accounting magazines, or an individual entrepreneur who has a license for pharmaceutical activities or for medical activities.

Appendix N 1 to the rules.

Appendix N 1.
to the rules

Journal of Accounting Operations related to the appeal of medicines for medical use

Appendix N 2 to the rules. Journal of Accounting Operations related to the appeal of medicines for medical use

Appendix N 2.
to the rules

Journal of Accounting Operations related to the appeal of medicines for medical use

Appendix N 3 to the rules. Journal of Accounting Operations related to the appeal of medicines for medical use

Journal of Accounting Operations related to the appeal of medicines for medical use

____________________

* It is indicated in the case of individual purpose and discharge of the drug with a specific patient.

Appendix N 2. Rules for maintaining and storing special accounting logs related to the appeal of medicines for medical use

Appendix N 2.
to order

1. These Rules establish the requirements for the conduct and storage of special journals for accounting operations related to the appeal of medicines for medical use included in the list of medicines for medical use to be subject to subject-quantitative accounting (hereinafter, respectively - accounting magazines, drugs).
________________
(Assembly of the legislation of the Russian Federation, 2010, N 16, Article 1815, N 31, Article 4161, N 42, Article.5293, N 49, Article.6409; 2011, N 50, Article 7351; 2012, N 26, Article 3446; N 53, Article 7587).

2. These rules do not apply to the conduct and storage of special journals for accounting operations related to the appeal of drugs containing narcotic drugs, psychotropic substances and their precursors and included in the lists II, III, IV list of narcotic drugs, psychotropic substances and their precursors subject to Control in the Russian Federation, as well as combined drugs, which contain other pharmacologically active substances in addition to narcotic drugs, psychotropic 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 " About narcotic drugs and psychotropic substances "provides for control measures similar to those established against narcotic drugs, psychotropic substances and their precursors contained in them.
Resolution of the Government of the Russian Federation dated June 30, 1998 N 681 "On approval of a list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation" (Meeting of the legislation of the Russian Federation, 1998, N 27, Article 3198; 2004, N 8 , Article 663; N 47, Article 4666; 2006, N 29, Article.3253; 2007, N 28, Article 3439; 2009, N 26, Article.3183; N 52, Article 6572; 2010, N 3 , st.314; n 17, st.2100; N 24, st.3035; N 28, st.3703; N 31, Article 4271; N 45, Article 5864; N 50, Article.6696, Article.6720 ; 2011, N 10, Article 1390; N 12, Article 1635; N 29, Article 4466, Article 4473; N 42, Article 5921; N 51, Article 7534; 2012, N 10, Article 1232 ; N 11, Article 1295; N 19, Article.2400; N 22, Article 2864; N 37, Article 5002; N 48, Article 6686; N 49, Article 6861; 2013, N 9, Art. 953; N 25, Article.3159; N 29, Article 3962; N 37, Article 4,06; N 46, Article.5943; N 51, Article 6869; 2014, N 14, Article 1626; N 23, .2987; N 27, st.3763; N 44, Article.6068; N 51, Article 7430; 2015, N 11, Article 1593; N 16, st.2368; N 20, st.2914; N 28, Article 4232; N 42, Article 5805; 2016, N 15, Article 2088; 2017, N 4, Article.671, N 10, Article 1481, N 23, Article.3330; N 30, Article 4664; N 33, Art. 5182).
(Footnote in the editorial office introduced from May 14, 2018 by order of the Ministry of Health of Russia of April 5, 2018 N 149n.

Meeting of the legislation of the Russian Federation, 1998, N 2, Article 279; 2002, N 30, Article.3033; 2003, N 2, Article 167; N 27, Article 2700; 2004, N 49, Art.4845; 2005, N 19, Article 1752; 2006, N 43, Article 4412; N 44, Art.4535; 2007, N 30, Art.3748; N 31, Article 4011; 2008, N 30, Art.3592; N 48, Art.5515; N 52, Article.6233; 2009, N 29, Article 3588, 3614; 2010, N 21, st.2525; "N31, Article 4192; 2011, N 1, Article 16, Article.29; N 15, Article 2039; N 25; Article.3532; N 49, Article.7019, Article 7061; 2012, N 10, Article 1166; N 53, Article 7630; 2013, N 23, st.2878; N 30, Article.4057; N 48, Article 6161, Article 6165; 2014, N 23, Article 2630; 2015, n 1, Article 54; N 6, Article 885; N 29, Article 4388; 2016, N 1, Article.28; N 15, Article 2052; N 27, Article 4160; Article 4238.
(Footnote is additionally included since May 14, 2018 by order of the Ministry of Health of Russia of April 5, 2018 N 149n)

3. The introduction and storage of special journals for accounting operations related to the appeal of the drugs specified in paragraph 2 of these Rules are carried out in accordance with the rules of conducting and storing special logs of registration of operations related to the turnover of narcotic drugs and psychotropic substances, approved by the Government Decree of the Russian Federation. On November 4, 2006, N 644, and the rules for conducting and storing special journals for registration of operations related to the turnover of drug precursors and psychotropic substances, approved by the Decree of the Government of the Russian Federation of June 9, 2010 N 419.
________________
Meeting of the legislation of the Russian Federation, 2006, N 46, Article 4795; 2008, N 50, Art. 5946; 2010, N 25, Art.3178; 2012, N 37, Art. 5002.

Meeting of the legislation of the Russian Federation, 2010, N 25, Article 3178; 2011, N 51, Article 7534; 2012, N 1, Article 1930, N 41, Art. 5623, N 51, Article.7235.

4. Accounting magazines filled on paper, will be dropped, are numbered and fastened by the signature of the head of the legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur) before the start of their maintenance.

Accounting magazines are executed on the calendar year.

5. Sheets of accounting magazines filled in electronic form are printed monthly, numbered, signed by the person authorized to keep and storing accounting logs, and put on the names of the drug, dosage, dosage form.

Upon the expiration of the calendar year, the discarded sheets are issued into the magazine, sealed with the number of sheets and are certified by the signature of the person authorized to conduct and storing accounting magazines, the head of the legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur).

6. Records in accounting magazines are made by a person authorized to keep and storing the accounting magazine, a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the arrival and drug-expenditure operations.

7. Receipt of the medicinal product is reflected in the accounting log for each receipt document separately with the number and date. Drug consumption is written daily. Pharmacy organizations and individual entrepreneurs who have licenses for pharmaceutical activities record daily drug consumption indicating separately by recipes written by medical professionals, and according to the requirements of medical organizations.

8. Corrections in accounting magazines are assigned by the signature of the person authorized to keep and storing accounting logs. Susks and incomplete corrections in accounting magazines are not allowed.

9. For the last number of each month, the person authorized for the maintenance and storage of accounting magazines conducts reconciliation of the actual presence of medicines with their balance on the account log and makes relevant records in the accounting log.

10. Accounting magazine is stored in a metal cabinet (safe), the keys from which are at the person authorized to keep and storing the accounting magazine.

Parishes and expenditure documents (their copies) are mounted in the order of their receipts by dates and are stored together with the accounting magazine.

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



Editorial Document Taking into account
changes and additions prepared
JSC "Codex"

On approval of the regulations for registration of operations related to the appeal of medicines for medical use included in the list of drugs for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the appeal of medicines for medical applications, and regulations and storage Special Magazines Accounting Operations related to the appeal of medicines for medical use

from 31.10.2017 N 882n, from 05.04.2018 N 149n)

Appendix N 1.
to the order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

REGULATIONS
Registration of operations related to the appeal of medicines for medical use included in the list of medicines for medical use to be subject to subject and quantitative accounting, in special accounting journals related to the treatment of medicines for medical applications

(as amended by orders of the Ministry of Health of the Russian Federation of 31.10.2017 N 882n, from 04/05/2018 N 149n)

1. These Rules establish the requirements for registration of operations related to the appeal of medicines for medical use included in the list of medicines for medical use to be subject to commercial accounting<1> (hereinafter - drugs), as a result of which their number and (or) condition changes.

<1> Federal law of April 12, 2010 N 61-FZ "On the circulation of medicines" (meeting of the 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. Registration of operations related to the appeal of drugs containing narcotic drugs, psychotropic substances and their precursors and included in the lists, III, a list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation<2>as well as combined drugs that contain other pharmacologically active substances in except for narcotic drugs, psychotropic substances and their precursors in respect of which in accordance with