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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of May 10, 2018 No. 71

About the reference book of international non-proprietary names 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 Agreement on the Eurasian Economic Union of May 29, 2014) 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 the enclosed passport of the reference book of international non-proprietary names of medicines.

2. Apply the reference book of international non-proprietary names of medicines (further - the reference book) according to the passport approved by this Decision.

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

4. Determine that:

the reference book is applied from the date of the introduction of this Decision in force;

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

5. 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 May 10, 2018, No. 71

Passport of the reference book of international non-proprietary names of medicines

№ of payment order

Designation of element

Description

1

2

3

1

Code

016

2

Type

1 - reference book

3

Name

reference book of international non-proprietary names of medicines

4

Abbreviation

MHH

5

Designation

EU 016 - 2018 (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 May 10, 2018 No. 71

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 May 10, 2018 No. 71

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 for Medical Application of the Russian Ministry of Health

11

Appointment

the reference book is intended for identification of the medicines of pharmaceutical substances which are part according to the unique name applied around the world which is public property including when marking medicines, forming registration files and registration certificates of medicine, in case of control of its address and monitoring of safety of its use

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 state 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

international non-proprietary name, generic name, medicine, pharmaceutical substance, reference book

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 reference book is harmonized with international (interstate, regional) qualifiers and (or) standards:

the list of international non-proprietary names of medicines (International Nonproprietary Names for Pharmaceutical Substances (INN)) recommended by the World Health Organization.

Harmonization method:

1 - method of direct use of confidential source

16

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

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

17

Method of systematization (classification)

1 - serial method of systematization

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