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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 17, 2019 No. 159

About the qualifier of document types of the registration file of medicine and the reference book of structural elements of the registration file medicinal drug

(as amended on 25-06-2024)

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 qualifier of document types of the registration file of medicine (further - the qualifier);

the reference book of structural elements of the registration file of medicine (further - the reference book).

2. Turn on the qualifier and the reference book in structure of resources of single system of normative reference information of the Eurasian Economic Union.

3. Determine that:

the qualifier and the reference book are used from the date of the introduction of this Decision in force;

use of specification symbols of the qualifier and the 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. 159

Qualifier of document types of the registration file of medicine

I.

No. 71 is excluded according to the Decision of Board of the Eurasian economic commission of 25.06.2024

II. Passport of the qualifier of document types of the registration file of medicine

№ of payment order

Designation of element

Description

1

2

3

1

Code

058

2

Type

2 - qualifier

3

Name

qualifier of document types of the registration file of medicine

4

Abbreviation

KDRDLP

5

Designation

EC 058 – 2024 (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. 159

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. 159

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)

BY, Ministry of Health of the Republic of Belarus, authorized organization:


republican unitary enterprise "The Center of Examinations and Testing in Health Care"

11

Appointment

the qualifier is intended for submission of data on document types of the registration file of medicine according to requirements to execution of the registration file, the statutory rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78

12

Summary (scope)

it is used for ensuring information exchange in case of realization of general processes within the Eurasian Economic Union and functioning of information system in the field of drug circulation

13

Keywords

document of the registration file of medicine, registration file, medicine, general technical document

14

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

technical regulation

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