{"id":652589,"date":"2025-06-20T15:57:53","date_gmt":"2025-06-20T12:57:53","guid":{"rendered":"https:\/\/eba.com.ua\/?p=652589"},"modified":"2025-06-20T17:40:12","modified_gmt":"2025-06-20T14:40:12","slug":"biznes-spilnota-doluchylas-do-obgovorennya-dorozhnoyi-karty-stvorennya-novogo-regulyatora-u-farmatsevtychnij-sferi-organu-derzhavnogo-kontrolyu","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/biznes-spilnota-doluchylas-do-obgovorennya-dorozhnoyi-karty-stvorennya-novogo-regulyatora-u-farmatsevtychnij-sferi-organu-derzhavnogo-kontrolyu\/","title":{"rendered":"[:ua]\u0411\u0456\u0437\u043d\u0435\u0441 \u0441\u043f\u0456\u043b\u044c\u043d\u043e\u0442\u0430 \u0434\u043e\u043b\u0443\u0447\u0438\u043b\u0430\u0441\u044c \u0434\u043e \u043e\u0431\u0433\u043e\u0432\u043e\u0440\u0435\u043d\u043d\u044f \u0434\u043e\u0440\u043e\u0436\u043d\u044c\u043e\u0457 \u043a\u0430\u0440\u0442\u0438 \u0441\u0442\u0432\u043e\u0440\u0435\u043d\u043d\u044f \u043d\u043e\u0432\u043e\u0433\u043e \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u0430 \u0443 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0456\u0439 \u0441\u0444\u0435\u0440\u0456 \u2013 \u041e\u0440\u0433\u0430\u043d\u0443 \u0434\u0435\u0440\u0436\u0430\u0432\u043d\u043e\u0433\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e[:en]Business \u0441ommunity joins discussion on the roadmap for establishing a new pharmaceutical regulator, the State Control Authority[:]"},"content":{"rendered":"<p><\/p>\n<div class=\"slider__outer-container\">\n\t<div class=\"slider\">\n\n\t\t<div class=\"slider__container\">\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2176-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2176-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2176-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_1787-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_1787-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_1787-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2707-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2707-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2707-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2186-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2186-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/DSC_2186-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t<div class=\"slider__panel\">\n\n\t\t\t<div class=\"slider__info-container\">\n\n\t\t\t\t<div class=\"slider__counters\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__counter slider__counter--current\">01<\/span>\/<span class=\"slider__counter slider__counter--total\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\t<div class=\"slider__title\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__title__text\" style=\"display:none\">Photo: <\/span>\n\t\t\t\t\t\t<span class=\"slider__title__description\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__nav slider__nav--prev icon icon-long-arrow\">\n\t\t\t\t<span class=\"icon icon-arrow-l-thin\"><\/span>\n\t\t\t<\/div>\n\t\t\t<div class=\"slider__nav slider__nav--next icon icon-long-arrow arrow-right\">\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__fullscreen icon icon-full-size js_slick-fullscreen\"><\/div>\n\n\t\t<\/div>\n\n\t\t<span class=\"close-full-size\"><\/span>\n\n\t<\/div>\n<\/div>\n<p data-start=\"197\" data-end=\"837\">On 6 June 2025, representatives of the Ministry of Health of Ukraine met with the business community of the European Business Association to discuss the implementation of the provisions of the Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX, which will come into force on 1 January 2027. Ahead lies a year and a half during which a new and effective State Control Authority in the pharmaceutical sector must be established, alongside new procedures for businesses as stipulated by the law. Consequently, both the Ministry of Health and market participants are increasingly focused on the practical implementation of these new approaches.<\/p>\n<p data-start=\"839\" data-end=\"963\">One of the key topics of the meeting was the creation of the new State Control Authority (SCA), as envisaged by the Law.<\/p>\n<p data-start=\"965\" data-end=\"1230\">The event was attended by representatives of the European Business Association \u2013 Anna Bezruk, Manager of the Health Care Committee; Iryna Mahdik, Executive Director of the Clinical Trials Subcommittee; and Yevhen Kudriavets, Member of the Health Care Committee Board.<\/p>\n<p data-start=\"1232\" data-end=\"1427\">Representatives of the Ministry of Health presented the key stages of the roadmap for the establishment of the SCA to the business community, outlining the tasks planned for 2025, 2026, and 2027.<\/p>\n<p data-start=\"1429\" data-end=\"1484\"><strong>Key Stages of the Roadmap for Establishing the SCA:<\/strong><\/p>\n<p data-start=\"1486\" data-end=\"1495\"><strong data-start=\"1486\" data-end=\"1495\">2025:<\/strong><\/p>\n<ul data-start=\"1496\" data-end=\"1769\">\n<li data-start=\"1496\" data-end=\"1565\">\n<p data-start=\"1498\" data-end=\"1565\">Harmonisation of the Law \u201cOn Medicinal Products\u201d with the EU acquis<\/p>\n<\/li>\n<li data-start=\"1566\" data-end=\"1615\">\n<p data-start=\"1568\" data-end=\"1615\">Completion of calculations for fees and charges<\/p>\n<\/li>\n<li data-start=\"1616\" data-end=\"1662\">\n<p data-start=\"1618\" data-end=\"1662\">Finalisation of the organisational structure<\/p>\n<\/li>\n<li data-start=\"1663\" data-end=\"1769\">\n<p data-start=\"1665\" data-end=\"1769\">Self-assessment of the SCA within the framework of benchmarking with the European Medicines Agency (EMA)<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1771\" data-end=\"1780\"><strong data-start=\"1771\" data-end=\"1780\">2026:<\/strong><\/p>\n<ul data-start=\"1781\" data-end=\"1999\">\n<li data-start=\"1781\" data-end=\"1873\">\n<p data-start=\"1783\" data-end=\"1873\">Formation of the selection commission and holding of a competition for the Head of the SCA<\/p>\n<\/li>\n<li data-start=\"1874\" data-end=\"1918\">\n<p data-start=\"1876\" data-end=\"1918\">Termination of the State Medicines Service<\/p>\n<\/li>\n<li data-start=\"1919\" data-end=\"1955\">\n<p data-start=\"1921\" data-end=\"1955\">Transfer of real estate to the SCA<\/p>\n<\/li>\n<li data-start=\"1956\" data-end=\"1999\">\n<p data-start=\"1958\" data-end=\"1999\">Recruitment of civil servants and experts<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2001\" data-end=\"2010\"><strong data-start=\"2001\" data-end=\"2010\">2027:<\/strong><\/p>\n<ul data-start=\"2011\" data-end=\"2166\">\n<li data-start=\"2011\" data-end=\"2053\">\n<p data-start=\"2013\" data-end=\"2053\">Start of operations of the new regulator<\/p>\n<\/li>\n<li data-start=\"2054\" data-end=\"2166\">\n<p data-start=\"2056\" data-end=\"2166\">Transitional period for the Ministry of Health, the State Expert Centre (SEC), and the State Medicines Service<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2168\" data-end=\"2588\">The Ministry also presented preliminary calculations regarding the fees and charges to fund the new authority. Tentatively, approximately 70% of the SCA\u2019s budget will be funded by companies, with the remaining 30% coming from the state budget. Continued dialogue with the business community is expected to refine the approach to calculating these fees and determining their actual cost for businesses in Ukraine.<\/p>\n<p data-start=\"2590\" data-end=\"3168\">During the meeting, Anna Bezruk emphasised the importance of the Health Care Committee\u2019s position on ensuring a transparent selection process not only for the Head of the SCA but for the recruitment of all staff members. She also stressed the need for a clearly planned staffing structure aligned with the authority\u2019s functions. Additionally, the business community expects a clear and predictable roadmap for the transition period, including the adoption of secondary legislation, to prevent a legal vacuum during the transfer of powers from current bodies to the new regulator.<\/p>\n<p data-start=\"3170\" data-end=\"3447\">Yevhen Kudriavets highlighted the critical importance of a predictable and consistent transfer of functions from the SEC to the new regulator to ensure the continuity and predictability of registration procedures, which directly impact timely access to medicines on the market.<\/p>\n<p data-start=\"3449\" data-end=\"3881\">Iryna Mahdik, in turn, drew attention to the need for the timely creation and launch of the State Register of Clinical Trials, which is also mandated by the new Law. According to the legislation, no trial may be conducted without being entered into this register. Iryna noted that the launch of the register must coincide with the SCA&#8217;s operational start and that this requires the development of relevant secondary legislation.<\/p>\n<p data-start=\"3883\" data-end=\"4269\">The EBA thanks the Ministry of Health for facilitating this important discussion on a reform that will influence medicine availability for patients, the investment appeal of the sector for pharmaceutical producers, the entry of new medicines to the Ukrainian market, and continued industry contributions towards improving patient access to vital treatments and medical services.<\/p>\n<p data-start=\"4271\" data-end=\"4612\" data-is-last-node=\"\" data-is-only-node=\"\">We hope that cooperation between the government and business will intensify, allowing for the timely resolution of all concerns currently facing the business community. We are confident that effective collaboration between the state and business is key to successful reform and look forward to its continuation to achieve meaningful results.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>On 6 June 2025, representatives of the Ministry of Health of Ukraine met with the business community of the European Business Association to discuss the implementation of the provisions of the Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX, which will come into force on 1 January 2027. Ahead lies a year and a half [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":652597,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Business \u0441ommunity joins discussion on the roadmap for establishing a new pharmaceutical regulator, the State Control Authority - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/biznes-spilnota-doluchylas-do-obgovorennya-dorozhnoyi-karty-stvorennya-novogo-regulyatora-u-farmatsevtychnij-sferi-organu-derzhavnogo-kontrolyu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Business \u0441ommunity joins discussion on the roadmap for establishing a new pharmaceutical regulator, the State Control Authority - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On 6 June 2025, representatives of the Ministry of Health of Ukraine met with the business community of the European Business Association to discuss the implementation of the provisions of the Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX, which will come into force on 1 January 2027. 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\u0434\u043e\u0440\u043e\u0436\u043d\u044c\u043e\u0457 \u043a\u0430\u0440\u0442\u0438 \u0441\u0442\u0432\u043e\u0440\u0435\u043d\u043d\u044f \u043d\u043e\u0432\u043e\u0433\u043e \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u0430 \u0443 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0456\u0439 \u0441\u0444\u0435\u0440\u0456 \u2013 \u041e\u0440\u0433\u0430\u043d\u0443 \u0434\u0435\u0440\u0436\u0430\u0432\u043d\u043e\u0433\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e[:en]Business \u0441ommunity joins discussion on the roadmap for establishing a new pharmaceutical regulator, the State Control Authority[:] - European Business 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