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:
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 Eurasian economic commission (further - the Commission).
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.
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.
3. For the purpose of ensuring fulfillment of requirements in the field of drug circulation within the Union the Commission has the right to accept the recommendations concerning determination of optimum approaches which realization will allow to provide accomplishment of such requirements.
1. State members create the total market of the medicines conforming to requirements proper pharmaceutical the practician according to the principles specified in article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014.
a) taking measures, necessary for harmonization and standardization of the legislation of state members in the field of drug circulation;
b) adoptions of single rules and requirements of regulation of drug circulation;
c) ensuring unity of mandatory requirements to safety, efficiency and quality of medicines in the territories of state members and their observance;
d) ensuring single approaches to creation of system of quality assurance of medicines;
e) harmonizations of the legislation of state members in the field of control (supervision) in the field of drug circulation.
3. For the purposes of implementation of this agreement state members determine the public authorities authorized on implementation and (or) coordination of activities in the field of drug circulation.
4. Coordination of the activities directed to harmonization of the legislation of state members in the field of drug circulation is performed by the Commission.
5. The public authorities of state members specified in Item 3 of this Article hold the consultations sent for approval of line items of state members concerning regulation of drug circulation.
1. State members take measures for establishment of pharmacopoeian requirements of the Union by means of consecutive harmonization of pharmacopoeian Articles (general and private) the state pharmacopeias of state members.
2. Harmonization of the state pharmacopeias of state members is carried out with use of the international experience of harmonization of national pharmacopoeian requirements according to the concept approved by the Commission.
3. The pharmacopoeian Articles (general and private) approved by Pharmacopoeian committee of the Union in total form the Pharmacopoeia of the Union which affirms the Commission.
4. The private pharmacopoeian articles of the Pharmacopoeia of the Union establishing quality requirements of the medicines intended for the address within the Union are drafted according to the concept specified in Item 2 of this Article.
5. The procedure for activities of Pharmacopoeian committee of the Union is determined by the Commission.
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