Technical regulation

News on «Technical regulation»

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.
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Decisions on «Technical regulation»

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04/09/2024 12:00:00 am Решение Коллегии ЕЭК № 37 О внесении изменений в единую Товарную номенклатуру внешнеэкономической деятельности Евразийского экономического союза и Единый таможенный тариф Евразийского экономического союза в отношении элементов мембранных рулонного типа для фильтрования или очистки жидкостей
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04/09/2024 12:00:00 am Решение Коллегии ЕЭК № 36 Об утверждении Правил реализации общего процесса «Обеспечение информационного взаимодействия между уполномоченными операторами (органами) государств – членов Евразийского экономического союза при отслеживании перевозок с применением навигационных пломб по территориям двух и более государств – членов Евразийского экономического союза»
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04/09/2024 12:00:00 am Рекомендация Коллегии ЕЭК № 8 О внесении изменения в том VI Пояснений к единой Товарной номенклатуре внешнеэкономической деятельности Евразийского экономического союза
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04/09/2024 12:00:00 am Распоряжение Коллегии ЕЭК № 50 О проекте решения Совета Евразийской экономической комиссии «Об особенностях перемещения через таможенную границу Евразийского экономического союза товаров, предназначенных для использования в официальных международных спортивных мероприятиях, условиях их помещения под специальную таможенную процедуру и порядке ее применения»
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04/09/2024 12:00:00 am Распоряжение Коллегии ЕЭК № 49 О проекте Протокола о внесении изменений в Договор о Евразийском экономическом союзе от 29 мая 2014 года в части определения порядка взимания косвенных налогов при осуществлении электронной торговли товарами, реализуемыми физическим лицам

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Author’s article by Deputy Director of the Department of Entrepreneurship of the EEC Samat Aliev in the magazine 23 2015 Author’s article by Deputy Director of the Department of Entrepreneurship of the EEC Samat Aliev in the magazine "Practice of Integration. EEC": "Labour Migration in the Eurasian Economic Union" ​Самат Бикитаевич Алиев — д. т.н., профессор, академик Российской академии есте- ственных наук, заместитель директора Департамента развития предпринимательской деятельности Евразийской экономической комиссии. При участии С.Б. Алиева и под его непосредственным руководством разрабатываются проекты нормативно-право- вых актов Евразийской экономической комиссии и международные законопроекты в сфере интеллектуальной собственности по вопросам товарных знаков, коллектив- ного управления авторскими и смежными правами, единого таможенного реестра объектов интеллектуальной собственности, координации деятельности уполномо- ченных органов. Автор более 110 научных трудов, в том числе 20 монографий. Сфе- ра научной деятельности — реструктуризация угольной промышленности, развитие высшего образования, управление транснациональными корпорациями, стратегия развития интеллектуальной собственности, миграционные процессы.
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