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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of June 11, 2019 No. 95

About the reference book of the excipients used in case of production 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 the excipients used in case of production of medicines.

2. Apply the reference book of the excipients used in case of production 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 June 11, 2019, No. 95

The passport of the reference book of the excipients used in case of production of medicines

№ of payment order

Designation of element

Description

1

2

3

1

Code

019

2

Type

1 - reference book

3

Name

the reference book of the excipients used in case of production of medicines

4

Abbreviation

CBB

5

Designation

EU 019-2019 (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 June 11, 2019 No. 95

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 June 11, 2019 No. 95

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)

KG, Department of provision of medicines and medical equipment under the Ministry of Health of the Kyrgyz Republic

11

Appointment

the reference book is intended for submission of data on the excipients used in case of production of medicines in case of the description of composition of medicines in the registration file of medicine, when forming requirements to indicators of quality of excipients and to methods of their control

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

excipient, medicine

14

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

technical regulation

15

Use international (interstate, regional) classifications

2 - in case of development of the reference book international (interstate, regional) qualifiers and (or) standards were not used

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 by the chronological principle

18

Maintaining technique

the reference book is kept in electronic form according to procedure according to appendix No. 1

19

Structure

the structure and rekvizitny structure of the reference book (structure of fields of the reference book, area of their values and the rule of forming) shall match the description according to appendix No. 2

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