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.
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 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 EAEU expands list of light industry goods subject to marking with identification means The Eurasian Economic Commission's Council has considered a proposal submitted by the Russian Federation to expand the list of light industry goods subject to marking with identification means and has decided to amend existing regulatory legal acts of the Eurasian Economic Union. The amendments concern only the types of products subject to marking approved by Decision No. 127 of the Commission's Council "On the introduction of marking of certain light industry goods with identification means" dated November 18, 2019. The marking will be extended to suits, shirts, knitwear, articles made from faux fur and certain other types of clothing. In respect of these goods, the Union Member States may impose a ban on the circulation of unmarked products from April 1, 2024. "The gradual inclusion of new goods in the number of goods subject to marking is a logical step in developing the common system, enabling the consumer to make sure of their authenticity and increasing the competitiveness of honest market participants by reducing the share of illegal trade," emphasized Andrey Slepnev, EEC Minister in charge of Trade. It should be noted that the new commodity groups will be marked, as before, according to the unified rules. Along with that, the provisions of the basic technological organizational model of the EAEU system for marking goods with identification means, approved by Decision No. 19 of the Commission's Council dated March 5, 2019, shall be taken into account. Therefore, it will not be necessary to re-mark goods when they are circulated in the Union's territory.
12 Apr 2024 Entrepreneurs from EAEU countries and Iran to continue cooperation within Free Trade Agreement The Eurasian Economic Commission's Council approved an action plan aimed at implementing the Free Trade Agreement between the Eurasian Economic Union and the Islamic Republic of Iran dated December 25, 2023. The document envisages, inter alia, deepening cooperation between the parties' business communities.   "In particular, the issue of Iran's participation as a partner in the next Eurasian Economic Forum will be explored. As part of the meeting it is planned to organize and conduct the EAEU – Iran business dialogue," said Andrey Slepnev, EEC Minister in charge of Trade. In order to create a platform for business dialogue between the parties, it is planned to amend the current Memorandum of Cooperation between the Business Council of the Eurasian Economic Union and the Iran Chamber of Commerce, Industry, Mines and Agriculture dated September 25, 2019 or conclude a new memorandum. The activities within this platform will take into account such areas of sector-specific interaction as cooperation in transport, development of multimodal transportation, joint projects in research and development, establishment of cooperation ties between enterprises, projects of the fuel and energy complex, as well as energy efficiency, energy saving and renewable energy sources, education, medicine, and telecommunications. Proposals received from the business community will be elaborated and considered by the Joint Committee, a governing body established to discuss issues related to the application of the Agreement and further development of trade relations between the EAEU and Iran. Additionally, the parties will prepare a joint action plan of trade facilitation organizations, including business forums, exhibitions, business missions, etc.
11 Apr 2024 EAEU and Myanmar developing industrial cooperation The prospects for cooperation between the countries of the Eurasian Economic Union and Myanmar in the industrial sector were discussed at the first meeting of the joint working group on interaction between the Eurasian Economic Commission and the Government of the Republic of the Union of Myanmar, featuring Georgy Arzumanyan, Deputy Director of the EEC Industrial Policy Department. “The Eurasian Economic Union is open to mutually beneficial cooperation with Myanmar. About a year ago, the Commission and the Government of Myanmar signed a Memorandum of Cooperation and now we are actively discussing promising areas of work, including in industry,” emphasized Georgy Arzumanyan. He introduced his foreign colleagues to the activities of the Commission in this area, spoke about priority areas of work, joint projects of the EAEU states and tools for deepening industrial cooperation in the Union. Representatives of the Myanmar Ministry of Industry noted that the share of industry and construction in Myanmar's GDP was about 20%. The most developed industries in Myanmar are the extractive, textile and woodworking industries. In each of them, for example in light industry, it is possible to deepen mutually beneficial cooperation. It should be noted that in recent years, trade between the Union countries and Myanmar has been developing more and more actively. Russia mainly exports finished metal products, computer, electronic and optical equipment, petroleum products, chemical products and electrical equipment. Other Member States supply to Myanmar software and hardware, medicines, etc. Clothing and footwear are the main imports from Myanmar to Armenia, Belarus, Kazakhstan and Kyrgyzstan. Imports of manufacturing products to the EAEU market increased by almost a third over the year. The Memorandum of Interaction between the Eurasian Economic Commission and the Government of the Republic of the Union of Myanmar was signed on June 15, 2023. It contemplates the interaction in customs and technical regulation, industry, energy, transport, and a number of other areas.
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