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DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of September 22, 2015 No. 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 No. 2 to the Regulations of work of the Euroasian economic commission approved by the Decision of the Supreme Euroasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Euroasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" the Board of the Euroasian economic commission solved No. 108:

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 Euroasian economic commission

V. Khristenko

Approved by the Decision of Board of the Euroasian economic commission of September 22, 2015 No. 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 pharmakopeyny 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 Euroasian economic council of December 23, 2014 No. 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 Pharmakopeyny committee of the Eurasian Economic Union (further - Pharmakopeyny committee of the Union) the harmonized pharmakopeyny Articles (monographs) of the Pharmacopoeia of the Union representing pharmakopeyny Articles (monographs) prepared jointly by specialists of the states - members and approved in accordance with the established procedure by Pharmakopeyny 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 pharmakopeyny 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 pharmakopeyny Articles (monographs) this Concept determines the principles of interaction of Pharmakopeyny 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;

the choice of the main pharmacopeias taking into account which requirements harmonization of pharmacopeias of state members, determination of level of their priority shall be performed;

ensuring use of single procedure for carrying out harmonization of pharmacopeias of state members;

ensuring unity of the principles of development of pharmakopeyny Articles (monographs) of the Pharmacopoeia of the Union.

II. Modern approaches to harmonization of pharmacopeias of state members

The foundation of harmonization of the international pharmacopeias was laid in 1948 when the Secretariat of the World Health Organization (WHO) received the respective mandate. The first volume of the first edition of the International pharmacopeia was published in 1951 for the purpose of harmonization of quality requirements of pharmaceutical substances around the world.

Since 2012 for implementation of harmonization at the global level under the auspices of Expert committee of WHO on specifications of medicines active development of the standard of WHO "Proper pharmakopeyny practice" (GPhP) is performed.

The main objectives of the standard of WHO "Proper pharmakopeyny practice" (GPhP) are:

quality assurance of medicines at the global level by adoption of pharmakopeyny standards;

assistance to recognition of global pharmakopeyny activities; increase in trust of regulatory bodies to the pharmakopeyny quality standards of medicines at the global level;

strengthening of cooperation between all interested persons (national and regional pharmakopeyny committees and other organizations, regulatory bodies, representatives of pharmaceutical industry) and expense reduction, the pharmakopeyny quality standards of medicines connected with development;

simplification of the procedure of harmonization and recognition of the pharmakopeyny quality standards of medicines at the global level;

rendering to pharmakopeyny committees state members of support in their work on creation of the harmonized pharmakopeyny quality standards of medicines.

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