12 Apr 2024 Sports equipment and inventory included in Unified list of products regulated within EAEU At its meeting held on April 12, the Eurasian Economic Commission's Council supplemented the Unified List of products regulated within the Eurasian Economic Union with certain types of sports equipment and inventory. In particular, the List includes sports and fitness equipment and inventory – gates for football, mini-football, handball, and hockey, targets for skeet shooting and sporting events, as well as gymnastic equipment and inventory – combined asymmetric/parallel bars, parallel bars, crossbars, gymnastic devices for vaulting, balance beams, trampolines, rings, wall bars, lattice ladders, frame structures for climbing, wooden horses, goats, ropes, jumping tables, benches and mats, and tumbling tracks. "Unfortunately, injuries are not uncommon in physical activities, including sports competitions," noted Valentin Tataritsky, EEC Minister in charge of Technical Regulation. "As practice shows, existing but non-binding mechanisms to ensure the safety of sports equipment, for example voluntary certification, do not eliminate the problem. The decision adopted by the Commission's Council will certainly help improve the situation". The addition of certain types of sports equipment and inventory to the Unified List is the legal basis for establishing mandatory requirements to them. Now such requirements can be established either in the Union's technical regulations or in the relevant national legal acts.
12 Apr 2024 Rules for conducting bioequivalence studies of medicinal products amended On April 12, the Eurasian Economic Commission's Council amended the Rules for conducting bioequivalence studies of pharmaceuticals within the Eurasian Economic Union. The amendments concern two procedures – the selection of a reference preparation in conducting bioequivalence studies of medicinal products and the procedure for replacing human bioequivalence studies with model laboratory studies (conducting a biowaiver). The procedure for selecting reference medicinal products includes the possibility of selecting additional alternatives. As Valentin Tataritsky explained to the EEC Council members, "the amendment is due to the difficulties that arise with the supply of original pharmaceuticals, selected as reference ones, to the Union's customs territory". These options make it easier to procure pharmaceuticals in third countries as well as allow for the wider use of copied pharmaceuticals (generics) as reference medicines. Changes in the requirements to the biowaiver procedure include the possibility of using this procedure for prodrugs – medicines that contain initially inactive molecules, and their transformation into medicines occurs in the human body. There is another possibility - using this procedure for 3rd class medicines (poorly soluble but well absorbed medicines) without obtaining the approval of the Expert Committee on Medicines. The amendments are in line with similar regulations used in the European region, Asia and America countries, as well as approaches used by the World Health Organization to allow the circulation of generics.
12 Apr 2024 EAEU adopted uniform Rules for pharmaceutical inspections of pharmacovigilance systems of medicine manufacturers At its meeting held on April 12, the Eurasian Economic Commission's Council supplemented Decision No. 83 of the EEC Council dated November 3, 2016 with the Rules for pharmaceutical inspections for compliance with the requirements of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union. Valentin Tataritsky, EEC Minister in charge of Technical Regulation, noted: "The amendments are aimed at preserving medicines with a proven positive benefit-risk profile in circulation in the Union's pharmaceutical market and excluding from circulation and production those medicines that pose a threat to public health and well-being of the population". Nowadays, the authorized bodies of the Eurasian Economic Union States inspect the pharmacovigilance system of marketing authorization holders in accordance with the Member States' legislation. This creates the prerequisites for different approaches to pharmaceutical inspections of the pharmacovigilance system and possible non-recognition of the inspection results in some EAEU countries. The document adopted by the EEC Council establishes unified approaches to the procedures for conducting inspections of pharmacovigilance systems and interaction between the Member States' authorized bodies. Repeated (duplicate) inspections of medicine manufacturers by each of the Member States' inspectorates are eliminated, which will make it possible to optimize inspection resources. The Rules for pharmaceutical inspections of the pharmacovigilance system are harmonized with the current version of the European Rules and are based on the best practice and use of experience in assessing real issues of safety and efficacy of medicinal products circulating in the Union's pharmaceutical market.
10 Apr 2024 Valentin Tataritsky: "It is important to deepen the Eurasian integration in ensuring the uniformity of measurement” On April 9-10 in Minsk, Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Commission, took part in the international scientific and technical conference "Metrology 2024", dedicated to the 100th anniversary of establishing the Belarusian Chamber of Weights and Measures. More than 200 representatives of the metrology community from nine countries, including the Eurasian Economic Union States, discussed the issues of determining the prospects of metrology development, expanding the ways of interaction and cooperation, promoting quality improvement, introducing the metrology achievements in the real economy and others. "The technical regulation forms the basis of the Eurasian integration, where ensuring the uniformity of measurements predetermines the feasibility of taking certain technical measures," the EEC Minister noted. According to Valentin Tataritsky, the coordinated policy is currently implemented in 11 acts of the Commission. For example, since December last year a new edition of the Procedure for organizing interlaboratory comparative tests has been in effect, which creates the same conditions for interlaboratory comparisons and ensures comparability of product test results conducted as part of conformity assessment. In June 2023, the final document in the series of founding acts of the Union's law – the Procedure for calibration of measuring instruments – was adopted. The Commission started finalizing the rules of mutual recognition in order to extend it to the results of calibration of measuring instruments.Valentin Tataritsky emphasized that more than eight years had passed since the adoption of metrological procedures, so there was a practical need for their adjustment. The Commission jointly with the EAEU States ensured the elaboration and approval of a number of amendments to the Treaty on the Union. In particular, the updated versions of the terms "national standard" and "reference quantity value" have been elaborated. They are included in the "Third Major" Protocol on amendments to the Treaty on the Union, which has already been signed and is at the stage of ratification by the EAEU countries. A number of terminological adjustments in the metrological block are envisaged by the "Fourth Major" Protocol on amendments to the Treaty of the Union ("metrological traceability" and "standard sample"), which undergoes the internal legal procedures in the Member States. The draft "Fourth Major" Protocol also includes amendments that will regulate the possibility of single-source procurement in truly justified cases, which is of utmost importance for metrologists. This entails the procurement of goods for comparisons, verification, calibration of measurement unit standards and measuring instruments from the measurement standards, as well as the procurement of reference materials by testing laboratories carrying out works for compliance with the Union's regulations. In order to find the reason of low demand for the Union Procedures for conducting metrological works on the example of the most demanded metrological procedure – type approval, a pilot project on perfecting the mechanism of admission of measuring instruments (MI) for use within the EAEU is implemented within the Union. The project participants include Armenia, Belarus, Kyrgyzstan and Russia. The basic and the most in-demand MIs were selected for implementing the "pilot": electric power meters, non-automatic scales, heat meters, flow meters, and ultrasonic current transformers. To date, tests for type approval and verification of selected measuring instruments have already been completed in the Union countries participating in the pilot project. The project results have been discussed so far by the Working Group on updating the Union's law in the field of ensuring the uniformity of measurements. The results of the work carried out in Russia were considered on February 22, and the Belarusian results are scheduled to be considered on April 18. Then the dates for discussing the Armenian and Kyrgyz results will be determined. The EEC Minister has noted that the main problem of low demand for the Union Procedures for conducting metrological works is that without recognizing the approved type of measuring instruments in at least one Member State the type approval certificate will not be issued to the applicant. Accordingly, it is necessary to regulate the problem of issuing such a certificate when the metrological procedure results are not recognized by all the Union countries. For this purpose, the pilot project participants have worked out appropriate solutions. Despite the creation of the EAEU unified system of technical regulation, the Commission jointly with the Union countries still has a lot to do to ensure the uniformity of measurements. The EEC Minister is convinced: "The current stage of integration development in ensuring the uniformity of measurements has objective need to expand the areas in which this line should be developed. Nowadays, many people realize the need for a coordinated policy in such areas as the Union's common energy market, the Union's common market for medical products and medicines, the application of veterinary and phytosanitary measures, trade and the social sphere". According to Valentin Tataritsky, de facto development of the uniformity of measurements in these spheres is already underway. Along with that, the preparation of relevant amendments to the Treaty on the Union is being discussed today by the Commission. For example, three draft recommendations are being elaborated today in cooperation with metrologists and energy specialists from all the EAEU States. These are general approaches to measuring the quantity and quality parameters of electric power, oil and gas in the Union's common markets. The Eurasian Economic Commission takes an active position in discussing and developing various initiatives and scenarios aimed at deepening integration processes, including in the field of ensuring the uniformity of measurements. "An active dialogue with the Union countries' authorized bodies on forming an action plan for the Declaration on further development of the EAEU until 2030 and for the period until 2045 is conducted at the Commission's platform. We invite the Union States' metrology community to become more actively involved in this discussion," the EEC Minister suggested. "The issue is very important, and in its solution we should rely on a whole set of internal and external factors, and proceed from complex tasks, including those aimed at protecting the market from unsafe products and creating favourable conditions for developing the Union's business". On April 9, there was a working meeting between Valentin Tataritsky and Alexander Rogozhnik, Minister of Industry of the Republic of Belarus. They discussed relevant matters related to the functioning of the electronic passport systems for vehicles (vehicle chassis), self-propelled machines and other types of machinery. Arrangements were reached to further improve information exchange in this field. The topic is scheduled to be discussed at the next meeting of the Commission's Council on April 12. The international scientific and technical conference "Metrology 2024" dedicated to the 100th anniversary of the Belarusian Chamber of Weights and Measures was attended by representatives of the metrology community of Armenia, Azerbaijan, Belarus, Kazakhstan, China, Kyrgyzstan, Russia, Uzbekistan and Tajikistan.  
04 Apr 2024 Amendments to technical regulation for meat and meat products come into force from April 7 The amendments adopted by Decision No. 98 of the Eurasian Economic Commission's Council dated September 27, 2023, correct the requirements set in the technical regulation of the Customs Union On Safety of Meat and Meat Products (TR CU 034/2013) concerning information on the nutritional value of slaughter products and meat products indicated in the labeling. The relevance of the amendments is due to the fact that meat of slaughter animals and slaughter products, including those used as raw materials, are characterized by natural heterogeneity in protein and fat content. The amendments set permissible deviation limits of actual values of the nutritional substance content (nutritional value indicators) from those specified in the labeling: protein must be not less than 80% of the value specified in the labeling; fat, carbohydrates, energy value (caloric value) must not be more than 120% of the values specified in the labeling. For example, if an average protein value of 17 g (100%) per 100 g of product is indicated in the labeling of meat products, the actual protein value, taking into account the new requirements, must not be less than 13.6 g (80%) per 100 g of product. With an average fat value of 18 g (100%) per 100 g of product, the actual fat value must not be more than 21.6 g (120 %) per 100 g of product. A similar approach is stipulated by the requirements of the technical regulation of the Eurasian Economic Union On Safety of Poultry Meat and Poultry Products (TR EAEU 051/2021), effective from January 1, 2023. Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Commission, notes that the amendments are aimed at solving problems related to controlling the content of nutritional substances, taking into account the features of raw materials and specifics of the meat processing industry, as well as to prevent actions that mislead consumers by discrepancies in the actual values of protein, fat, carbohydrates and caloric content, specified in the labeling. According to Valentin Tataritsky, introduction of new requirements will have a positive impact on the business environment in the Union countries. Decision No. 15 of the Board of the Commission dated March 5, 2024 sets out a transitional period. It is stipulated that documents on conformity assessment of slaughter products and meat products, in respect of which amendments have been made, issued or adopted before April 7, 2024, are valid until the end of their validity period. Production and release into circulation of these products are allowed until the expiration of such documents; circulation of products is allowed within the shelf life established by the manufacturer.
01 Apr 2024 EEC develops cooperation with EAEU regional consumer association Promising areas of cooperation, as well as relevant matters of developing integration processes in the field of consumer rights protection were discussed at the meeting between Natalia Zhukova, Director of the EEC Department for Sanitary, Phytosanitary and Veterinary Measures, and the founders of the Eurasian Consumer Union. "Creating conditions for the activities of consumer public associations in the largest region of the world is one of the key directions of the coordinated policy of consumer rights protection enshrined in the Treaty on the EAEU," Natalia Zhukova noted. "Public organizations provide substantial assistance to public authorities in the legal protection of citizens, and help in solving many consumer problems, which is especially important during economic transformations". Svetlana Romanovskaya, Head of the Eurasian Consumer Union, informed that this organization was established in Kazakhstan to protect the interests of citizens and assist in settling transboundary consumer disputes in the Union's single market. It united more than 200 consumer public organizations of the EAEU and CIS countries. The founders of the Eurasian Consumer Union are the Belarusian Society of Consumers Protection, the National League of Consumers of Kazakhstan, the Consumers Union of the Russian Federation and the International Confederation of Consumer Societies. As Natalia Zhukova reported, the conducted research made it possible to assess the development of consumer public associations and identify problems to be addressed by the Commission's recommendations for the Union countries. Creating the Eurasian Consumer Association is the best example of practical application of the Commission's recommendations, which will enable to consolidate the efforts of society under a single banner and offer citizens new opportunities to assert their rights in the Union's market.  The meeting attendees exchanged views on the prospects of interaction within the Joint Action Program of the EAEU Member States in the field of consumer rights protection. The meeting noted the importance of strengthening interaction in terms of conducting a study on forming mechanisms to consider the interests of consumers in the Union's law. Following the events, the participants agreed to intensify work on deepening cooperation in all areas related to consumer rights protection in the EAEU, including in the context of the tasks of further development of economic processes within the EAEU until 2030 and for the period until 2045, envisaged in the Declaration "The Eurasian Economic Path". The meeting was attended by representatives of the Eurasian Consumer Union – Anna Susha, Chairman of the Belarusian Society of Consumers Protection, Svetlana Romanovskaya, Chairman of the National League of Consumers of Kazakhstan, Petr Shelishch, Chairman of the Consumers Union of the Russian Federation, and Dmitry Yanin, Chairman of the Board of the International Confederation of Consumer Societies. About 1.3 thousand consumer public associations are registered and operating in the EAEU, 95% of which are located in the Russian Federation. Along with that, given the total population of the Union countries, there are about 140 ths consumers per 1 consumer public organization.  
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