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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of August 21, 2018 No. 134

About the reference book of types of the changes made to the registration file of medical product

According to article 31 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 the enclosed reference book of types of the changes made to the registration file of medical product (further - the reference book).

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

3. 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 the address of medical products.

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 August 21, 2018, No. 134

The reference book of types of the changes made to the registration file of medical product

I. The disaggregated data from the reference book

Code

The name of type of the change made to the registration file of medical product

05

change of the name of medical product

10

change of structure of the accessories and (or) completing and (or) consumable materials

15

change of data on indications to use, scope, contraindications, side effects

20

change of information about the producer of medical product

25

change of the data containing in technical and (or) operational documentation on medical product

30

change of information about the applicant, including data on reorganization of the legal entity, on change of its name or surname, name and the residential address of the individual entrepreneur

99

another

II. Passport of the reference book

№ of payment order

Designation of element

Description

1

2

3

1

Code

017

2

Type

1 - reference book

3

Name

the reference book of types of the changes made to the registration file of medical product

4

Abbreviation

SVIRDMI

5

Designation

EU 017-2018 (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 August 21, 2018 No. 134

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 August 21, 2018 No. 134

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)

KZ, Ministry of Health of the Republic of Kazakhstan

11

Appointment

it is intended for submission of data on types of the changes made to the registration file of medical product

12

Summary

(scope)

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

13

Keywords

modification of the registration file, medical product

14

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

technical regulation

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