{"id":790752,"date":"2026-11-12T16:50:32","date_gmt":"2026-11-12T14:50:32","guid":{"rendered":"https:\/\/eba.com.ua\/?p=790752"},"modified":"2026-11-12T16:58:37","modified_gmt":"2026-11-12T14:58:37","slug":"ua-eba-ta-ministr-ohorony-zdorov-ya-obgovoryly-zapusk-ukrfarmagentstva-j-regulyatorni-zminy","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/ua-eba-ta-ministr-ohorony-zdorov-ya-obgovoryly-zapusk-ukrfarmagentstva-j-regulyatorni-zminy\/","title":{"rendered":"[:ua]EBA \u0442\u0430 \u043c\u0456\u043d\u0456\u0441\u0442\u0440 \u043e\u0445\u043e\u0440\u043e\u043d\u0438 \u0437\u0434\u043e\u0440\u043e\u0432\u2019\u044f \u043e\u0431\u0433\u043e\u0432\u043e\u0440\u0438\u043b\u0438 \u0437\u0430\u043f\u0443\u0441\u043a \u0423\u043a\u0440\u0444\u0430\u0440\u043c\u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u0430 \u0439 \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u043d\u0456 \u0437\u043c\u0456\u043d\u0438[:en]EBA and the Minister of Health discussed the launch of the Ukrainian Pharmaceutical Agency and regulatory changes[:]"},"content":{"rendered":"<p><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-790751\" src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-300x196.jpeg\" alt=\"\" width=\"650\" height=\"424\" srcset=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-300x196.jpeg 300w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-1024x668.jpeg 1024w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-768x501.jpeg 768w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-650x424.jpeg 650w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-136x90.jpeg 136w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-800x522.jpeg 800w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378-100x65.jpeg 100w, https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/11\/IMG_0378.jpeg 1187w\" sizes=\"(max-width: 650px) 100vw, 650px\" \/><\/p>\n<p data-pm-slice=\"1 1 []\">On 10 November, representatives of the European Business Association\u2019s Health Care Committee met with <strong>Viktor Liashko, Minister of Health of Ukraine, and the Ministry\u2019s team<\/strong>. The meeting was also attended by the management and representatives of the State Expert Center of the Ministry of Health of Ukraine and the Ukrainian Pharmaceutical Agency.<\/p>\n<p>The key topics of discussion included the launch of the Ukrainian Pharmaceutical Agency, preparations for the entry into force of the new Law of Ukraine \u201cOn Medicinal Products\u201d, and ensuring the continuity of medicinal product supplies amid the war.<\/p>\n<p>Business representatives emphasised that the implementation of large-scale regulatory changes requires clear transitional arrangements, the timely adoption of regulatory acts, and open dialogue between the government and business. Companies need to understand the new operating rules well in advance to plan their activities and ensure uninterrupted supplies of medicinal products at the beginning of 2027, while maintaining patients\u2019 access to the treatment they need.<\/p>\n<p>The meeting addressed the pharmaceutical market\u2019s preparations for operating under the new regulatory framework, as well as other pressing industry issues, including:<\/p>\n<ul>\n<li><strong>Launch of the Ukrainian Pharmaceutical Agency.<\/strong> The discussion focused on ensuring the continuity of regulatory procedures during the transition to the new system, completing the review of previously submitted applications, and selecting the new agency\u2019s team through an open competition.<\/li>\n<li><strong>Funding and independence of the regulator.<\/strong> The participants emphasised the importance of ensuring adequate financial and human resources for the Ukrainian Pharmaceutical Agency. Particular attention was paid to business contributions and the need for a transparent and economically justified approach to setting service fees.<\/li>\n<li><strong>Preparation of the regulatory framework.<\/strong> The participants discussed the timelines for adopting regulations on medicinal product registration, the assessment of registration dossiers, and the confirmation of manufacturing sites\u2019 compliance with Good Manufacturing Practice (GMP) requirements. Companies stressed the importance of having access to final versions of the documents in a timely manner to prepare for the new requirements.<\/li>\n<li><strong>Clinical trials.<\/strong> Particular attention was paid to the need to regulate the application of the 7% VAT rate to the import of medicinal products, medical devices, and equipment for clinical trials following the transfer of authorisation powers to the Ukrainian Pharmaceutical Agency. Ministry of Health representatives confirmed that this issue requires resolution and announced their intention to hold consultations with the Ministry of Finance of Ukraine and the relevant Committee of the Verkhovna Rada of Ukraine to develop the necessary solutions.<\/li>\n<li><strong>Transition to eCTD and medicinal product verification.<\/strong> The discussion covered the practical implementation of the new requirements, clear timelines, and the need to take into account companies\u2019 technical readiness and the additional burden on businesses under martial law.<\/li>\n<li><strong>Continuity of supply.<\/strong> The participants raised the issue of maintaining the agreed mechanisms during martial law, including the use of alternative warehouse facilities and the performance of certain wholesale trade operations under an import licence. Difficulties related to the supply of medical devices and equipment were also discussed.<\/li>\n<li><strong>Price regulation and access to treatment.<\/strong> The discussion covered the operation of the National Price Catalogue, application review timelines, and opportunities to streamline the process. The participants also discussed the development of the reimbursement system, updates to the National List of Essential Medicines, and health technology assessment.<\/li>\n<\/ul>\n<p>The Ministry of Health informed the participants about its ongoing work on a number of issues raised by the Association and the preparation of decisions to address them. Further discussions will take place at separate meetings focusing on the Ukrainian Pharmaceutical Agency\u2019s service fees, the transition to eCTD, and the implementation of the medicinal product verification system.<\/p>\n<p>The European Business Association thanks the Minister and all meeting participants for the open and constructive dialogue. We look forward to further cooperation and joint efforts to develop solutions aimed at advancing the industry and improving patients\u2019 access to treatment.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>On 10 November, representatives of the European Business Association\u2019s Health Care Committee met with Viktor Liashko, Minister of Health of Ukraine, and the Ministry\u2019s team. The meeting was also attended by the management and representatives of the State Expert Center of the Ministry of Health of Ukraine and the Ukrainian Pharmaceutical Agency. The key topics [&hellip;]<\/p>\n","protected":false},"author":4489,"featured_media":790751,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EBA and the Minister of Health discussed the launch of the Ukrainian Pharmaceutical Agency and regulatory changes - 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\/ua-eba-ta-ministr-ohorony-zdorov-ya-obgovoryly-zapusk-ukrfarmagentstva-j-regulyatorni-zminy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EBA and the Minister of Health discussed the launch of the Ukrainian Pharmaceutical Agency and regulatory changes - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On 10 November, representatives of the European Business Association\u2019s Health Care Committee met with Viktor Liashko, Minister of Health of Ukraine, and the Ministry\u2019s team. 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