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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 22, 2015 №119

About the Concept of harmonization of pharmacopeias of state members of the Eurasian Economic Union

According to article 5 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 27 of appendix № 2 to the Regulations of work of the Euroasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 №98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 №108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" the Board of the Eurasian economic commission decided:

1. Approve the enclosed Concept of harmonization of pharmacopeias of state members of the Eurasian Economic Union.

2. This Decision becomes effective from the effective date Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014.

Chairman of Board of the Eurasian economic commission

V. Khristenko

Approved by the Decision of Board of the Eurasian economic commission of September 22, 2015 №119

Concept of harmonization of pharmacopeias of state members of the Eurasian Economic Union

I. Introduction

Harmonization of requirements to medicines is necessary process in operating conditions of the total market of medicines within the Eurasian Economic Union (further - the Union). At the present stage of regulation of the total market harmonization is one of methods of development of pharmacopoeian standards of state members of the Union (further - state members).

This Concept is developed according to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 5 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and the Decision of the Supreme Eurasian economic council of December 23, 2014 № 108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union".

This Concept determines model and the principles of development of the Pharmacopoeia of the Eurasian Economic Union (further - the Pharmacopoeia of the Union) on the basis of pharmacopeias of state members and the main pharmacopeias, approval by Pharmacopoeial committee of the Eurasian Economic Union (further - Pharmacopoeial committee of the Union) the harmonized pharmacopoeia lArticles (monographs) of the Pharmacopoeia of the Union representing pharmacopoeial Articles (monographs) prepared jointly by specialists of the states - members and approved in accordance with the established procedure by Pharmacopoeial committee of the Union, and approval of the Pharmacopoeia of the Union by Board of the Euroasian economic commission for the purpose of establishment of transparency of all procedures in this sphere, and also providing continuity of process of development of the new harmonized pharmacopoeial Articles (monographs).

The concept covers questions of harmonization of pharmacopeias of state members both regarding medicines for medical application, and regarding veterinary medicines.

For the purpose of implementation of proper development, modification, updating and approval of the harmonized pharmacopoeial Articles (monographs) this Concept determines the principles of interaction of Pharmacopoeial committee of the Union and authorized bodies of state members in the sphere of drug circulation regarding creation of single Pharmacopoeia of the Union.

This Concept is directed to realization of the following tasks:

forming of model of harmonization of pharmacopeias of the states - members;

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