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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 29, 2015 №177

About Rules of maintaining the nomenclature of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, the paragraph the 2 Item 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 24 of appendix №2 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Euroasian economic council of December 23, 2014 № 98, and for the purpose of execution of the Decision of the Supreme Euroasian economic council of December 23, 2014 №109"About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" the Board of the Eurasian economic commission decided:

1. Approve the enclosed Rules of maintaining the nomenclature of medical products.

2. Determine the operator of the nomenclature of medical products of the Eurasian Economic Union the Federal Service by supervision in the field of health care.

3. The Eurasian economic commission together with authorized bodies of state members of the Eurasian Economic Union in the field of health care to consider question of creation of working group for coordination of works on creation and maintaining the nomenclature of medical products of the Eurasian Economic Union.

4. This Decision becomes effective after 30 calendar days from the effective date of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 or from the effective date the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 depending on what date is later, but not earlier than after 30 calendar days from the date of official publication of this Decision.

Chairman of Board of the Eurasian economic commission

V. Khristenko

Approved by the Decision of Board of the Eurasian economic commission from __________ 20 __ years №. _____

Rules of maintaining nomenclature of medical products

I. General provisions

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and the paragraph the 2 Item 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, extend to the medical products registered within the Eurasian Economic Union (further - the Union), and determine procedure for forming and maintaining the nomenclature of medical products of the Union.

2. For the purposes of these rules concepts which mean the following are used:

"The agency of the Global nomenclature of medical products" - the organization responsible for forming and maintaining the Global nomenclature of medical products;

"type of medical product" - set of the medical products having similar or similar appointment and (or) the device;

"The global nomenclature of medical products" (Global Medical Device Nomenclature) - the systematized nomenclature qualifier of types of medical products used for the purpose of identification of medical products;

"the nomenclature of medical products of the Union" - the systematized nomenclature qualifier of types of medical products harmonized with the Global nomenclature of medical products and used within the Union.

II. Procedure for forming and maintaining nomenclature of medical products of the Union

3. The nomenclature of medical products of the Union contains list of types of medical products with indication of nomenclature names, unique codes and descriptions of types of the medical products including classification signs of medical products depending on purpose of medical products and (or) their devices.

4. The name and the description of each type of medical products included in the nomenclature of medical products of the Union shall match the name and the description of type of medical products included in the Global nomenclature of medical products.

5. For the purposes of systematization of types of the medical products included in the nomenclature of medical products of the Union the categories of medical products included in the Global nomenclature of medical products are used.

6. The nomenclature of medical products of the Union is part of single system of the normative reference information of the Union created according to Items 4,5 and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix № 3 to the Agreement on the Eurasian Economic Union of May 29, 2014).

7. The nomenclature of medical products of the Union is created and kept by the operator of the nomenclature of medical products of the Union in electronic form, is placed the Eurasian economic commission (further - the Commission) on information portal of the Union on the Internet (further - the Internet), is public and is provided to users on non-paid and non-discriminatory basis.

8. The operator of the nomenclature of medical products of the Union performs the following functions:

a) provides transfer into Russian of names of types of medical products and descriptions of their types included in the Global nomenclature of medical products and brings them in the nomenclature of medical products of the Union with assignment of unique codes;

b) provides transfer into Russian of the medical products of names of new types of medical products and descriptions of their types, and also data on the changes made to the names of types of medical products included in the Global nomenclature of medical products and the description of their types received from the Agency of the Global nomenclature and makes corresponding changes to the nomenclature of medical products of the Union;

c) provides assignment of unique codes to the new types of medical products included in the nomenclature of medical products of the Union;

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