Eurasian Economic Union

The Eurasian Economic Union (EAEU)  is an international economic integration organization of 5 member states:

• Armenia,
• Belarus,
• Kazakhstan,
• Kirghizstan,
• Russia.

The EAEU was established for the purpose of comprehensive modernization, cooperation, and competitiveness of national economies and the creation of conditions for stable development in order to improve the living standards of the population of the Member States. The population of the EAEU is 184 million people. The total GDP is $1,838 billion and is the 10th in the world.

In order to create a common market in the EAEU, common principles and rules for the registration and circulation of medicines and common technical regulations for medical devices, foods and cosmetics are being introduced in accordance with the Eurasian Economic Union Agreement of 29 May 2014.

The overall volume of the pharmaceutical market in EAEU countries is more than 17 billion dollars. The Agreement on Common Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union dated December 23, 2014 is a fundamental document for the establishment of a common market of human medicines. Common rules for expert examination of medicines, common rules of GMP, GVP, GCP, GDP, GLP, common rules for inspection, common requirements for labeling of medicines and many other legislative acts have been approved. The Union Pharmacopoeia is in the process of preliminary discussion.

In March 2018, the first Applications for registration of medicines under the Common Rules were submitted, and as of November 2019, 6 medicines were registered under the procedure of bringing them into compliance with the EAEU requirements, and more than 200 Applications are under assessment.

In all EAEU Member States, as of the end of 2019, medicinal products are allowed to be registered both under the national procedure and under the common rules of EAEU. The requirement to register drugs under the Common Rules of the Union will be mandatory for pharmaceutical manufacturers from January 2021. At the same time, all medicinal products registered under the national procedures should be brought into compliance with the EAEU requirements by the end of 2025.

Functioning of the common market of medical devices within the Union is carried out in accordance with the Agreement on the Eurasian Economic Union of May 29, 2014, the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014. Rules for the assessment and registration of medical devices, rules of classification, rules of testing and research have been approved. A special symbol for the circulation of medical devices on the EEU market has been introduced.

As of the end of 2019, all EAEU Member States are allowed to register medical devices both under the national procedure and under common EAEU rules. The requirement to register medical devices and medical equipment under the Unified Rules of the Union will be mandatory from January 2021. At the same time, all medical devices registered according to national procedures should be brought into compliance with EAEU rules by the end of 2021.

It is discussed to postpone the extension of procedures for the national registration of medical devices and equipment, as well as to bring them into line with the unified rules of the EAEU by 2026, with a transitional period until 2031.

The unified market of food products is regulated by a number of Technical regulations, some of which were approved back in 2011 by the regulations of the Customs Union, the legal predecessor of the EAEU: “On the safety of food products”, “Food products in terms of their labeling”, “Safety requirements for food additives, flavorings and technological excipients”, “On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition” and others.

Perfumery and cosmetic products are also regulated by the common legal acts of the Union, the main of which is the Technical Regulations “On Safety of Perfumery and Cosmetic Products”.

Food and perfumery and cosmetic products in all EAEU Member States are subject to state registration only under the “centralized” procedure according to the applicable Technical Regulations.   An obligatory labeling element is a unified symbol of product circulation in the market of the EAEU Member States. At the same time, products must be labeled in the Russian language, as well as in the languages of those countries where they are planned to be placed (if there is a mandatory requirement in the legislation of a Member State).

For food, perfumery, cosmetic, hygienic and household products there is the Unified Register of Certificates of State Registration of the EAEU, which as of the end of 2019 totals about 560 000 certificates.

Competent authorities: 

Eurasian Economic Commission (EEC)
The permanent supranational regulatory body of the Eurasian Economic Union (EAEU)
Web site: http://www.eurasiancommission.org/

EEC Expert Committee on Medicines
The competent authority of the Eurasian Economic Union responsible for the development and implementation of legislation on the circulation, safety, quality and efficiency of medicines
Web site: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/orls.aspx

Authorized bodies or expert organizations of an EAEU Member State:

Academician Emil Gabrielyan Scientific Center of Expertise on Medicines and Medical Technologies under the Ministry of Health of the Republic of Armenia
Web site: http://www.pharm.am/

State Unitary Enterprise “State Centre for Expertise and Testing in Healthcare” of the Ministry of Health of the Republic of Belarus
Web site: https://www.rceth.by/

National Centre for Expertise of Medicines, Medical Devices and Medical Equipment of the Republic of Kazakhstan
Web site: https://www.ndda.kz/

Department of Medicine and Medical Technology of the Ministry of Health of the Kyrgyz Republic
Web site: http://www.pharm.kg/

Federal State Budgetary Institution “Scientific Centre of Expertise of Medical Application Equipment” of the Ministry of Health of Russia
Web site: https://www.regmed.ru/

Basic legislative acts in the sphere of circulation of medicines: 

1. Agreement on common principles and rules for the circulation of medicines within the Eurasian Economic Union dated December 23, 2014;
2. The decision of the Council of the Eurasian Economic Commission No. 75 of November 3, 2016 “On approval of the Regulations on the Expert Committee on Medicines”;
3. The decision of the Council of the Eurasian Economic Commission No. 76 of November 3, 2016 “On approval of the labeling requirements for medicinal products for medical use and veterinary medicines”;
4. The decision of the Council of the Eurasian Economic Commission No. 77 of November 3, 2016 “On approval of Good Manufacturing Practice Rules of the Eurasian Economic Union”;
5. The decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016 “On the rules of registration and expertise of medicines for medical use”;
6. The decision of the Council of the Eurasian Economic Commission No. 79 “On approval of the Rules of Good Clinical Practice of the Eurasian Economic Union” dated November 3, 2016;
7. The decision of the Council of the Eurasian Economic Commission No. 82 of November 3, 2016 “On approval of General requirements for a quality system of pharmaceutical inspectorates of the Eurasian Economic Union member states”;
8. The decision of the Council of the Eurasian Economic Commission No. 83 of November 3, 2016 “On approval of the Rules of pharmaceutical inspections”;
9. The decision of the Council of the Eurasian Economic Commission No. 85 of November 3, 2016 “On approval of the Rules for conducting bioequivalence studies of drugs within the Eurasian Economic Union”;
10. The decision of the Council of the Eurasian Economic Commission No. 87 of November 3, 2016 “On Approval of the Rules of Good Pharmaceutical Inspection Practice of the Eurasian Economic Union”;
11. The decision of the Council of the Eurasian Economic Commission No. 88 of November 3, 2016 “On approval of requirements for guidelines for medicinal products and general characteristics of medicinal products for medical use”;
12. The decision of the Council of the Eurasian Economic Commission No. 93 of November 3, 2016 “On Recognition of the Results of the Inspection of Medicinal Products Production”;
13. The decision of the EEC Collegium No. 151 of September 7, 2018 “On Approval of the Guidelines for Drafting a Regulatory Document on the Quality of Medicinal Products”;
14. EEC Collegium recommendation No. 28 of September 10, 2019 “On Guidelines for determining the scope of laboratory tests during an expert examination of medicines”.

Basic legislative acts in the field of circulation of medical devices: 

1. Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union;
2. The decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”;
3. The decision of the Council of the Eurasian Economic Commission No. 26 of February 12, 2016 “On the special sign of circulation of medical devices”;
4. The decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 27 “On approval of the General requirements for safety and efficiency of medical devices, requirements for their marking and operational documentation on them”;
5. The decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 28 “On approval of the Rules for technical testing of medical devices”;
6. The decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 29 “On the rules of clinical and clinical laboratory tests (researches) of medical devices”;
7. The decision of the Council of the Eurasian Economic Commission No. 30 of February 12, 2016 “On Approval of the Procedure for Formation and Maintenance of Information System in the Sphere of Circulation of Medical Devices”;
8. The decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 42 “On approval of the list of types of medical devices to be referred to measuring instruments during their registration”;
9. The decision of the Council of the Eurasian Economic Commission on May 16, 2016 № 38 “On approval of the Rules of research (testing) to assess the biological effects of medical devices”;
10. The decision of the Council of the Eurasian Economic Commission No. 141 of December 21, 2016 “On approval of the Procedure for application by authorized bodies of the Eurasian Economic Union member states of measures on suspension or prohibition of the use of medical devices that are dangerous for life and/or health of people, malignant, counterfeit or falsified medical devices and their withdrawal from circulation in the territories of the Eurasian Economic Union member states”;
11. The decision of the Council of the Eurasian Economic Commission No. 106 dd. 10.11.2017 “On approval of Requirements for introduction, maintenance, and evaluation of quality management system for medical devices depending on the potential risk of their use”;
12. The decision of the Board of the Eurasian Economic Commission on December 22, 2015 № 173 “On approval of the Rules of classification of medical devices depending on the potential risk of use”;
13. The decision of the Board of the Eurasian Economic Commission on December 22, 2015 № 174 “On approval of the Rules for monitoring the safety, quality and efficiency of medical devices”;
14. The decision of the Collegium of the Eurasian Economic Commission of June 30, 2017 № 78 “On Requirements for the electronic type of applications and registration dossier documents submitted during the registration and examination of the safety, quality and efficiency of medical devices”;
15. The decision of the Board of the Eurasian Economic Commission on September 26, 2017 № 123 “On the Regulations on the advisory committee for medical devices”;
16. The decision of the Board of the Commission No. 47 of April 3, 2018 “On the classifier of types of adverse events related to the use of medical devices”;
17. The decision of the Board of the Commission No. 48 of April 3, 2018 “On Classifier of Medical Device Registration File Types of Documents”;
18. The decision of the Collegium of the Eurasian Economic Commission No. 116 of July 24, 2018 “On Criteria for Delimitation of Elements of a Medical Device Being Components of a Medical Device with the Purpose of its Registration”;
19. The decision of the Collegium of the Eurasian Economic Commission No. 123 of July 24, 2018 “On Criteria for Inclusion in one registration certificate of several modifications of a medical device related to one type of medical device in accordance with the nomenclature of medical devices applied in the Eurasian Economic Union”;
20. Recommendation of the Collegium of the Eurasian Economic Commission of September 4, 2017 № 16 “On the Procedure for the formation of a list of standards, as a result of the application of which on a voluntary basis, fully or partially ensures compliance of medical devices with General requirements for safety and efficiency of medical devices, requirements for their marking and operational documentation on them”;
21. Recommendation of the Collegium of the Eurasian Economic Commission No. 17 of September 4, 2017 “On the list of standards resulting from the application of which, on a voluntary basis, compliance of medical devices with General Safety and Efficiency Requirements for Medical Devices, labeling requirements and operational documentation for them is ensured in full or in part”;
22. Recommendation of the Collegium of the Eurasian Economic Commission of November 12, 2018 № 25 “On the criteria for attributing products to medical devices within the Eurasian Economic Union”;
23. Recommendation of the EEC Collegium of May 21, 2019 No. 14 “On Methodological Recommendations for Examination of Safety, Quality and Efficiency of Medical Devices for Registration within the Eurasian Economic Union”;
24. Recommendation of the Collegium of the Eurasian Economic Commission of October 8, 2019 № 29 “On methodological recommendations on the content and structure of documents of the registration dossier of a medical device”.

Cratia provides professional services of state registration of medical (healthcare) products in the Eurasian Economic Union. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:

• registration of medicinal products in the Eurasian Economic Union;
• establishment and maintenance of the pharmacovigilance system in the EAEU;
• certification (conformity assessment / registration) of medical devices in the EAEU;
• certification of special food products in the EAEU;
• certification of cosmetic products in the EAEU.