23 May 2024 Valentin Tataritsky: “The EEC acts have provided a stable platform for functioning of the EAEU common market of medicines” This was stated by Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Commission, at the strategic session “Integration processes for establishing the EAEU common market of medicines” as part of the scientific-practical conference “Regulatory Practice and Registration of Medicines – RegLek 2024”, held on May 21-23 in Moscow. The session was devoted to the results of work to ensure the functioning of the Union's common market of medicines and discussion of proposals to improve the Commission's acts shortly before the end of the transition period on December 31, 2025, according to which all medicines circulating in the EAEU market should be harmonized with the Eurasian single regulatory framework. The event was opened with a welcoming speech by Mikhail Murashko, Minister of Health of the Russian Federation. The session was attended by Deputy Ministers of Health of the EAEU States and representatives of the pharmaceutical business. They presented their experience in the common market of medicines and shared their vision of its development prospects. According to Valentin Tataritsky, more than 15,000 applications for registration of medicines under the Union's rules have been submitted by March of this year, including more than 6,500 applications under the harmonization procedure. About 5,700 marketing authorizations have been issued. All the EAEU States joined the work. Russia accounts for most of this work, but this year the number of applications from other Union countries for registration of medicinal products and harmonization of their marketing authorization applications has increased significantly. The EEC Minister touched upon the main stages of evolution of the Marketing Authorization Rules in 2016-2024. In particular, they were supplemented with provisions on the registration of pandemic and pre-pandemic vaccines, defined terms for the sale of medicine residues after their compliance with the Union's requirements, simplified a number of procedures, including the procedures for harmonizing the marketing authorization applications, and introduced the possibility of “remote” testing in the manufacturer's laboratory, which made it possible to overcome logistical COVID restrictions. The list of registration procedures was also supplemented with procedures for simplified and accelerated access to the market for breakthrough and high-performance medicinal products. In 2023, the Marketing Authorization Rules were updated with sections on high-technology medicinal products, the possibility to submit a marketing authorization application without a GMP certificate with inspection during registration or in the post-registration period was extended until December 31, 2024, and the number of documents to be submitted in marketing authorization applications for previously registered medicinal products was significantly reduced. In 2024, the procedure for making amendments to the marketing authorization application has already been updated, and by the end of the year it is planned to make further clarifications in terms of requirements for products placed in the packaging of a medicinal product and provisions for determining the confidentiality of expert report data. Valentin Tataritsky emphasized that today the EAEU system of GxP practices, which constitute the life cycle of any medicine, and inspection procedures to confirm compliance with these practices are developing in a rather dynamic way. In 2018, in addition to the five basic good practices (GLP, GCP, GMP, GDP, GVP), the Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin was adopted, and in April 2024, the Pharmaceutical Inspection Regulations were supplemented with an inspection procedure for pharmacovigilance systems. The EEC Minister noted the evolution of pharmacopoeial cooperation between the EAEU countries, which is of particular importance in terms of its scientific and practical potential. At the meeting of the Commission's Board in June-July 2024, it is planned to adopt the third part of the first volume of the Union Pharmacopoeia devoted to the quality analysis of radiopharmaceutical medicinal products and biological (biotechnological) pharmaceuticals. The conference thematic sections included reports from representatives of the EAEU Member States' authorized bodies and organizations on developing medicines circulation and medicine provision, control and supervision activities in this field, and bringing the legislation in compliance with the EEC acts and the practice of their application in the Union countries. In their reports, employees of the EEC Technical Regulation and Accreditation Department informed the conference attendees about special aspects of the adopted and planned changes in registration procedures, as well as development of the GxP system and research. The Scientific and Practical Conference “RegLek”, organized by the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia, is one of the main annual events in the pharmaceutical sector. Subjects of the EAEU pharmaceutical market consider relevant matters of medicine circulation and law enforcement practice.  
23 May 2024 Representatives of Commission's Industrial Unit participated in Metalworking-2024 Exhibition Representatives of the Eurasian Economic Commission's Industrial Unit headed by Nikolay Rogozhnik, Deputy Director of Industrial Policy Department, visited the international specialized exhibition of equipment, devices and tools for the metalworking industry “Metalworking-2024”, during which they took part in the plenary session “Future of Machine Tool Building. Trends and Prospects”, as well as thematic round tables. On the sidelines of the event, Nikolay Rogozhnik informed on the new mechanism of financial support to the EAEU industrial cooperation, as well as the conditions and opportunities for its use. “For the first time since the existence of the Eurasian Economic Commission, an efficient support mechanism in the field of industrial cooperation has been launched, which enables the Union countries' enterprises to implement significant strategic projects”, Nikolay Rogozhnik noted. The Commission's delegation got acquainted with the exhibition exposition of the Gomel Machine Tools and Assemblies Plant, where a high-tech numerically controlled lathe, model 16GS25FZ was presented. The machine was assembled in the Republic of Belarus, the share of localized Russian components in the machine was 61% and the Belarusian components accounted for 30%. According to Nikolay Rogozhnik, the high-tech lathe is an excellent result of close cooperation between Russia and Belarus on the way to achieving technological sovereignty of the Eurasian Economic Union.
23 May 2024 Authorized economic operators may receive new simplifications Draft decisions of the Commission aimed at expanding the benefits of the authorized economic operator (AEO) concept in the Eurasian Economic Union, were discussed on May 23 at the meeting of the relevant Working Group under the Advisory Committee on developing the AEO concept headed by Sergei Vladimirov, Director of the Eurasian Economic Commission's Department for Customs Legislation and Law Enforcement Practice. “AEOs are a low-risk category”, Sergei Vladimirov noted. “The requirements we place on AEOs should be fully offset for them by the ability to apply the full range of simplifications”. One of them is the decision related to the provision of an opportunity for AEOs to store goods placed under the customs procedure of a customs warehouse at their facilities, which will significantly improve the logistics of the movement and use of goods in different economic sectors of the Union States. Another decision will allow AEOs to apply the simplifications granted to operators in relation to excisable goods subject to marking, i.e. to eliminate the exemptions that have existed for many years. The Authorized Economic Operator concept is an internationally recognized standard of the partnership program. The AEOs are specially designated persons granted with simplifications during customs operations and customs control as persons meeting specified requirements. The Working Group for developing the AEO concept in the EAEU Member States was established in 2014. It elaborates proposals to improve and develop the Authorized Economic Operator concept in the Union.
22 May 2024 EAEU and Mongolia strengthen trade and economic interaction and expand cooperation Intensifying trade and economic cooperation between the EAEU countries and Mongolia was discussed at the scientific conference “Prospects for developing trade, economic and investment cooperation between Mongolia and the EAEU countries” on May 21 in Ulaanbaatar. The plenary discussion was addressed by Sergei Glazyev, Minister in charge of Integration and Macroeconomics. “Mongolia became the first State among third countries to formalize contacts with the Eurasian Economic Commission in 2015, having concluded the relevant Memorandum,” Sergei Glazyev said. “Next year it will be 10 years since the systematic work of the EEC and the Government of Mongolia was launched, the purpose of which is to promote the development of comprehensive cooperation between the Union countries and Mongolia, as well as to increase the efficiency of mutual trade and the implementation of measures aimed at eliminating barriers hindering its development”. The EEC Minister also noted that implementing the Memorandum encouraged the development of sector-specific interaction between the EEC and the Mongolian state administration bodies, primarily in the fields of technical regulation and SPS-measures, and provided the groundwork for the work on preparing a temporary trade agreement between Mongolia, the Union and the EAEU Member States. According to the EEC Minister, the key objectives for the near future include the intensification of work on eliminating barriers to developing trade and economic cooperation between the EAEU and Mongolia. He emphasized the importance of transiting to national currencies when making payments, using own payment and settlement platforms, reviving cooperation ties and building up joint investments through establishing joint ventures in geological exploration, mining, processing of raw materials, as well as implementing infrastructure and transport and logistics projects. “The problem of trade imbalance can be compensated by increasing cooperation ties, establishing joint ventures in Mongolia and investments by corporations from the EAEU,” Sergei Glazyev summarized. These and other issues of trade and economic cooperation will be the focus of attention of the joint Working Group on interaction between the EEC and the Government of Mongolia, created in accordance with the above Memorandum. The Working Group actively involves not only representatives of the EEC and Mongolian state administration bodies, but also representatives of interested ministries and agencies, as well as business circles of the EAEU States. The event was organized by the Russian Academy of National Economy and Public Administration under the President of the Russian Federation. The conference was attended by representatives of the diplomatic corps of the EAEU Member States, public authorities, business circles and academia of the EAEU States and Mongolia.
22 May 2024 Prospects for industrial cooperation between EAEU and Mongolia discussed at international conference Nikolay Kushnarev, Director of the Industrial Policy Department of the Eurasian Economic Policy, addressed the international conference “Prospects for developing trade, economic and investment cooperation between Mongolia and EAEU countries” in Ulaanbaatar. During the panel session “Developing cooperation in the industrial and agricultural sectors of the Eurasian Economic Union countries and Mongolia” Nikolay Kushnarev noted the long-standing trusting relations and close ties between the EAEU States and Mongolia, including in the field of industrial and technological cooperation, as well as the possibility to deepen interaction by drafting an agreement on creating a free trade area between Mongolia and the EAEU. “The growth of Mongolia's economy in the basic mining industry supports stable demand for equipment, machinery and spare parts. At the same time, Mongolia's course for developing and expanding infrastructure and transport projects, as well as the need to build new power generation facilities, creates the need to attract technologies and competencies. Such demand and needs are good prerequisites for deepening cooperation in the manufacturing industry between Mongolia and the EAEU countries and can act as one of the key drivers for achieving ambitious development goals and economic growth”, noted the Director of the Department. Nikolay Kushnarev informed the conference attendees on the possibilities and mechanisms of cooperation in mastering the manufacture of products using more sophisticated technological processes with high added value, including in relation to the industrial recovery program of Mongolia within the national “Policy of Economic Recovery”. Among such mechanisms, he noted the Eurasian Technological Platforms, which can become a systemic tool in scientific and technological and innovation cooperation and technology transfer. The mechanism of the EAEU industrial zones in third countries is another possible option for developing and deepening interaction between the Eurasian “five” countries and Mongolia.
20 May 2024 Valentin Tataritsky: “The EAEU has long felt need to strengthen Union integration in the field of standardization and metrology” Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Union, informed on cooperation between the Eurasian Economic Union countries in the field of standardization and metrology at the meeting of the final Board of the Federal Agency for Technical Regulation and Metrology (Rosstandart). The Board of Rosstandart was attended by more than 200 people, including the central office and all subordinate organizations of Rosstandart, representatives of the Eurasian Economic Commission, ministries and relevant institutions of the Russian Federation.  Valentin Tataritsky reminded that May 29 will mark the 10th anniversary of signing the Treaty on the EAEU, noting that during this period much has been achieved in the field of technical regulation and Rosstandart has played an active role in this process. According to the EEC Minister, the objective of standardization in the near future is to implement the Procedure for coordinating standardization work within the Union, as well as the Procedure for conducting mandatory periodic assessment of the scientific and technical level of enacted regulations and lists of standards thereto. These documents are aimed at keeping the requirements up to date, as well as their coordinated and timely preparation. Besides, Valentin Tataritsky informed that this year it is planned to discuss the results of implementing the pilot project to perfect a mechanism of the admission of measuring instruments within the EAEU. Specific proposals for settling legal gaps identified in the pilot project will be formulated to amend the Union's acts. The EEC Minister stressed that, despite the work done, there is already an urgent need to strengthen the Union integration in the field of standardization and metrology in the current realities. “Joint ambitions for developing these blocks should have been included in the action plan for implementing the Declaration on further development of economic processes within the Union until 2030 and for the period until 2045,” he noted. In his speech, Valentin Tataritsky noted that digitalization plays a significant role in developing technical regulation. According to him, implementing the most ambitious project on the Union platform – “Digital Technical Regulation within the Union” – is the first step towards “technical regulation of the future”. “The expert team that directly implements this project, which is a whole consortium, is now "laying down" the prospects for filling the single digital platform being created with the Union's services already functioning or still being created,” Valentin Tataritsky said. “Subsequently, such a system will enable us to move step by step towards digitizing the very process of conformity assessment and issuance of authorizations, as well as automation of supervisory activities in the field of technical regulation”. The event was also timed to coincide with the World Metrology Day celebrated annually by the metrology professional community on May 20. This date will be celebrated in 2024 under the motto “We measure today for a sustainable future”. The Eurasian Economic Commission joins, within its powers, to implementing this motto.
Display more