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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 17, 2019 No. 158

About the nomenclature of dosage forms and the reference book of ways of introduction of medicines

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the specified Agreement) and being guided items 4 by the Regulations on single system of normative reference information of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of November 17, 2015 No. 155, Board of the Eurasian economic commission solved:

1. Approve enclosed:

the nomenclature of dosage forms (further - the nomenclature);

the reference book of ways of introduction of medicines (further - the reference book);

Procedure for maintaining nomenclature of dosage forms and reference book of ways of introduction of medicines.

2. Include the nomenclature and the reference book in structure of resources of single system of normative reference information of the Eurasian Economic Union.

3. Determine that:

the nomenclature and the reference book are applied from the date of the introduction of this Decision in force;

use of specification symbols of the nomenclature and reference book is obligatory in case of realization of general processes within the Eurasian Economic Union in the field of drug circulation.

4. This Decision becomes effective after 30 calendar days from the date of its official publication.

Chairman of Board of the Eurasian economic commission

T. Sargsyan

Approved by the Decision of Board of the Eurasian economic commission of September 17, 2019 No. 158

Nomenclature of dosage forms

I. Passport of the nomenclature

№ of payment order

Designation of element

Description

1

2

3

1

Code

057

2

Type

2 - qualifier

3

Name

nomenclature of dosage forms

4

Abbreviation

NLF

5

Designation

EC 057-2019 (edition 1)

6

Details of the act of adoption (approval) of the reference book (qualifier)

The decision of Board of the Eurasian economic commission of September 17, 2019 No. 158

7

Date of Introduction in action (the beginning of use) of the reference book (qualifier)

from the effective date Decisions of Board of the Eurasian economic commission of September 17, 2019 No. 158

8

Details of the act of phase-out of the reference book (qualifier)

-

9

End date of use of the reference book (qualifier)

-

10

Operator (operators)

RU, Ministry of Health of the Russian Federation. Authorized organization: federal state budgetary institution "Scientific Center of Examination of Means of Medical Application" of the Ministry of Health of the Russian Federation

11

Appointment

the qualifier is intended for standardization of names of the dosage forms used during the marking of medicines, creation of the registration file of medicines, forming of the unified register of the registered medicines of the Eurasian Economic Union and information databases in the field of drug circulation

12

Summary (scope)

it is used when forming of the state members of the Eurasian Economic Union of documents represented by subjects of drug circulation to authorized bodies, including in electronic form, and also for ensuring information exchange in case of realization of general processes within the Eurasian Economic Union

13

Keywords

dosage form, medicine, medicine, way of introduction, introduction method, release modification

14

The sphere in which powers of bodies of the Eurasian Economic Union are implemented

technical regulation

15

Use international (interstate, regional) classifications

1 - the qualifier is harmonized with international (interstate, regional) the ISO 11239 standard "Informatization of health. Identification of medicines. Elements of data and structure for unique identification and exchange of information about the registered dosage forms, representation units, ways of introduction and packaging"

16

Availability of the state reference books (qualifiers) of state members of the Eurasian Economic Union

2 - the qualifier has no analogs in state members of the Eurasian Economic Union

17

Method of systematization (classification)

4 - the combined classification method according to the Technique of classification and coding of information in the nomenclature of dosage forms according to appendix

18

Maintaining technique

the qualifier is conducted maintaining the nomenclature of dosage forms and the reference book of ways of introduction of medicines, in electronic form according to the Procedure, approved by the Decision of Board of the Eurasian economic commission of September 17, 2019 No. 158

19

Structure

information on structure of the qualifier (structure of fields of the qualifier, area of their values and the rule of forming) is provided in the Section II of this document

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