Procedure for harmonizing marketing authorization application for six groups of veterinary medicinal products in accordance with EAEU Rules simplified 24 May 2024 Procedure for harmonizing marketing authorization application for six groups of veterinary medicinal products in accordance with EAEU Rules simplified The Eurasian Economic Commission’s Council has adopted amendments to the Rules for regulating the circulation of veterinary medicines in the Eurasian Economic Union's customs territory. The procedure for harmonizing marketing authorization applications for six groups of veterinary medicinal products has been simplified: these are vitamins, antiparasitic agents for non-productive animals, plant preparations, antiseptics, as well as preparations intended to restore the water-electrolyte balance in the body of animals and preparations containing minerals as active substances. Previously, the procedure for harmonizing the marketing authorization application of these groups of veterinary medicines with the new requirements had to be agreed upon by each authorized body of the Member State in which territory these medicines were planned to be circulated, but after the amendments, no agreement will be required. Along with that, these medicines should be manufactured in the EAEU and be in circulation in its territory for more than five years. The adopted document also corrects certain provisions of the EAEU Rules of a clarifying and technical nature. The EEC Council supported the proposal of the Kyrgyz Republic to study within six months the issue of making amendments to the Rules envisaging the procedure for registration of veterinary medicinal products registered under the Rules in one of the Member States on the initiative of the EAEU country. This will enable to further reduce the risk of shortages in veterinary medicines in the States with “small markets”. Implementing all the adopted amendments will help reduce the financial burden on manufacturers of veterinary medicines, and therefore reduce their cost price. Furthermore, the administrative burden on the Union countries' authorized bodies will be reduced as well.
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.  
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.
17 May 2024 EEC protects single market from products non-compliant with Union's requirements The draft Procedure for interaction between state control (supervision) bodies as well as state control (supervision) bodies and accreditation bodies of the Eurasian Economic Union was considered at a meeting held at the venue of the Eurasian Economic Commission under the chairmanship of Tatiana Nikolaeva, Deputy Director of the EEC Technical Regulation and Accreditation Department. The document was prepared to implement paragraph 4.7.1 of the Strategy-2025. During the discussion, the EAEU Member States' experts considered problematic issues related to the protection of the Union's single market from products that do not meet the requirements of the Union's legislation. These include the sequence of actions of a supervisory authority when such products are detected in its territory for prompt information sharing with other control bodies of the Member States, as well as the required composition of information to be transmitted within the reporting system. Some approaches implemented by control bodies to taking measures in respect of the named products, as well as approaches to termination or suspension of conformity assessment documents by supervisory authorities or other authorized bodies in accordance with the national legislation were considered. The legal status of conformity assessment documents in the Union's unified register of conformity assessment documents in the event of termination or suspension of their validity in the territory of one of the Member States was discussed. “The adoption of the Interaction Procedure will enable the state control bodies of the Union countries to promptly exchange information on non-compliant products within the information system for taking response measures,” Tatiana Nikolaeva noted. Prompt interaction of state control (supervision) bodies, including with accreditation bodies, will help protect the single market from non-compliant products and unreasonably issued conformity assessment documents.  The draft Procedure will be submitted to the Eurasian Economic Commission's Council for consideration by the end of this year.
16 May 2024 Valentin Tataritsky: “It is important to deepen confidence of the Union countries’ consumers in state and public institutions for the protection of their rights” The results of implementing the Joint Action Program of the Eurasian Economic Union countries on consumer rights protection and the prospects for developing the Eurasian integration in this field were considered on May 16 at a meeting of the EAEU States’ Advisory Committee on Consumer Rights Protection chaired by Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Commission. The EEC Minister emphasized the importance of defining the priorities of the Union countries’ joint work until 2030, where special attention should be paid to strengthening public confidence in state and public institutions of consumer rights protection amid the development of digitalization, introduction of innovative technologies and intelligent services in the fields of trade and services. The Advisory Committee members emphasized the importance of exchange of views and experience at the relevant session of the 6th Eurasian Digital Forum to be held as part of the program of the 30th International Forum on Information and Communication Technologies TIBO-2024 on June 5–8 this year in Minsk. The Commission presented an analysis of the EAEU countries’ legislation and the Union’s law, which revealed that the mechanism for respecting the consumer interests is underdeveloped and not regulated. In this regard, the Advisory Committee members proposed to organize a “consumer-entrepreneur” dialogue within the EAEU Business Council, as well as to develop procedures for assessing the consequences of the introduced regulation to respect the consumers’ interests. The next step towards the formation of mechanisms for respecting the consumers’ interests will include the generation of proposals to improve the procedures for elaborating draft regulatory acts relating to the consumers’ interests. The meeting discussed a report on exercising in the EAEU countries the rights of citizens to after-sales service for technically sophisticated goods. The consumers’ risks associated with inadequate post-warranty maintenance, as well as the prospects for establishing requirements to services for operating technically sophisticated goods, were considered. It was noted that consumers face the problem common to all Union countries — misconduct of sellers and service centers that impose additional services, as well as insufficient awareness of citizens in this field. The differences in consumer rights protection mechanisms when buying low-quality goods in the EAEU countries were discussed. In order to minimize the identified differences and to ensure equal conditions for consumer rights protection when buying technically sophisticated goods, the Advisory Committee initiated the preparation of the Commission’s relevant recommendation for the Union countries.
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