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of December 23, 2014

About the single principles and rules of drug circulation within the Eurasian Economic Union

The state members of the Eurasian Economic Union which are referred to as further with state members

based on the Agreement on the Eurasian Economic Union of May 29, 2014,

confirming intention to develop economic cooperation and to expand trade and economic relations,

recognizing that medicines belong to socially important products,

for the purpose of forming of the total market of medicines within the Eurasian Economic Union (further - the Union),

setting as the purpose strengthening of health of the population of state members by ensuring access to safe, effective and high-quality medicines,

recognizing feasibility of carrying out the coordinated policy in the field of drug circulation taking into account mutual interest in providing security guarantees, efficiency and quality of medicines for life and human health, environmental protection, life and health of animals and plants, the prevention of the actions misleading consumers

aiming at creation of optimal conditions for development of pharmaceutical industry, to increase in competitiveness of the pharmaceutical products made in the territories of the states - members, and to entry into the world market,

aiming at elimination of unreasonable restrictions in mutual trade,

agreed as follows:

Article 1. Determinations

1. For the purposes of this agreement concepts which mean the following are used:

"medicine" - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and conditions of the person;

"medicine" - medicine in the form of dosage form;

"proper pharmaceutical practicians in the field of drug circulation" (further - proper pharmaceutical practicians) - the rules extending to all stages of drug circulation: proper laboratory practice, proper clinical practice, proper production practice, proper distributor practice, proper pharmaceutical practice, proper practice of pharmakonadzor and other practicians;

"drug circulation" - the activities including processes of development, preclinical researches, clinical trials (testing), examinations, registration, pharmakonadzor, quality control, production, production, storage, transportation, import to customs area of the Union and export from customs area of the Union, movement from the territory of one state member in the territory of other state members, leave, realization, transfer, application, destruction of medicines;

"pharmaceutical substance" - the medicine intended for production and production of medicines.

2. State members when forming the total market of medicines within the Union are guided by the unified concepts and their determinations according to the information reference book of concepts and determinations in the field of drug circulation which forming and maintaining is performed by the Euroasian economic commission (further - the Commission).

Article 2. Scope of the Agreement

1. This agreement establishes the single principles and rules of drug circulation within the Union for the purpose of forming of the total market of medicines within the Union.

2. Action of this agreement extends to the legal relationship arising in the field of drug circulation, being in circulation within the Union.

Article 3. Regulation of drug circulation

1. Regulation of drug circulation within the Union is performed according to this agreement, other international treaties entering the right of the Union, decisions of the Commission and the legislation of state members.

The decisions of the Commission regulating the address, medicines are developed on the basis of the international standards.

2. State members send to the Commission of the offer concerning project development of acts of bodies of the Union in the field of drug circulation.

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