{"id":764011,"date":"2026-08-18T10:16:15","date_gmt":"2026-08-18T07:16:15","guid":{"rendered":"https:\/\/eba.com.ua\/?p=764011"},"modified":"2026-08-18T10:18:15","modified_gmt":"2026-08-18T07:18:15","slug":"asotsiatsiya-otrymala-ofitsijni-roz-yasnennya-dets-shhodo-praktychnoyi-implementatsiyi-nakazu-moz-302","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/asotsiatsiya-otrymala-ofitsijni-roz-yasnennya-dets-shhodo-praktychnoyi-implementatsiyi-nakazu-moz-302\/","title":{"rendered":"[:ua]\u0410\u0441\u043e\u0446\u0456\u0430\u0446\u0456\u044f \u043e\u0442\u0440\u0438\u043c\u0430\u043b\u0430 \u043e\u0444\u0456\u0446\u0456\u0439\u043d\u0456 \u0440\u043e\u0437\u2019\u044f\u0441\u043d\u0435\u043d\u043d\u044f \u0414\u0415\u0426 \u0449\u043e\u0434\u043e \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u043d\u043e\u0457 \u0456\u043c\u043f\u043b\u0435\u043c\u0435\u043d\u0442\u0430\u0446\u0456\u0457 \u043d\u0430\u043a\u0430\u0437\u0443 \u041c\u041e\u0417 \u2116302[:en]EBA receives official clarifications from the State Expert Center on the practical implementation of MoH Order No. 302[:]"},"content":{"rendered":"<p><\/p>\n<p data-start=\"124\" data-end=\"540\">Following the working meeting held on <a href=\"https:\/\/eba.com.ua\/en\/biznes-obgovoryv-z-dets-moz-ukrayiny-praktychnu-implementatsiyu-onovlenogo-poryadku-provedennya-klinichnyh-vyprobuvan\/\">18 June 2026 between members of the European Business Association\u2019s Clinical Trials Subcommittee and representatives of the State Expert Center of the Ministry of Health of Ukraine<\/a>, the Association requested confirmation of its understanding of certain clarifications provided during the discussion and submitted a number of additional questions requiring written clarification.<\/p>\n<p data-start=\"542\" data-end=\"1038\">During the meeting, participants discussed a wide range of practical issues related to the implementation of amendments to the Procedure for Conducting Clinical Trials of Medicinal Products and the Examination of Clinical Trial Materials, approved by Order No. 302 of the Ministry of Health of Ukraine dated 10 March 2026. To ensure a common understanding of the new regulatory requirements and their proper practical application, the Subcommittee submitted a corresponding request to the Center.<\/p>\n<p data-start=\"1040\" data-end=\"1181\">We are pleased to announce that the State Expert Center has provided official clarifications on the issues raised. In particular, they cover:<\/p>\n<ul data-start=\"1183\" data-end=\"1671\">\n<li data-section-id=\"10u8oon\" data-start=\"1183\" data-end=\"1244\">general aspects of the implementation of MoH Order No. 302;<\/li>\n<li data-section-id=\"17ekyxo\" data-start=\"1245\" data-end=\"1344\">submission of documents to the Ministry of Health of Ukraine and the initial examination process;<\/li>\n<li data-section-id=\"50t9m9\" data-start=\"1345\" data-end=\"1401\">requirements for the composition of the research team;<\/li>\n<li data-section-id=\"a4mdu1\" data-start=\"1402\" data-end=\"1449\">requirements for medicinal product labelling;<\/li>\n<li data-section-id=\"1h8475s\" data-start=\"1450\" data-end=\"1506\">informed consent and the use of electronic signatures;<\/li>\n<li data-section-id=\"176ppb\" data-start=\"1507\" data-end=\"1591\">submission of quality certificates, certificates of analysis and GMP certificates;<\/li>\n<li data-section-id=\"1bsukz3\" data-start=\"1592\" data-end=\"1671\">other practical issues arising from the application of the updated Procedure.<\/li>\n<\/ul>\n<p data-start=\"1673\" data-end=\"1991\">The clarifications received provide an important practical tool for companies already operating, or planning to operate, under the new regulatory requirements. They will contribute to a consistent approach to their application and help minimise the risk of ambiguous interpretation of individual regulatory provisions.<\/p>\n<p data-start=\"1993\" data-end=\"2567\">The Clinical Trials Subcommittee would like to express its sincere gratitude to the State Expert Center of the Ministry of Health of Ukraine for its open and constructive dialogue, willingness to cooperate and provision of additional clarifications for the business community. Special thanks go to the Center&#8217;s experts for promptly addressing the issues raised by members of the Clinical Trials Subcommittee. Such cooperation contributes to greater predictability of regulatory procedures and the effective implementation of new requirements in the field of clinical trials.<\/p>\n<p data-start=\"2569\" data-end=\"2756\"><strong data-start=\"2569\" data-end=\"2756\">We invite members of the Clinical Trials Subcommittee to review the State Expert Center&#8217;s letter and use the clarifications provided in their day-to-day activities \u2014 <a href=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2026\/08\/Vidpovid_DETS_nakaz302.pdf\">available here<\/a>.<\/strong><\/p>\n<p data-start=\"2758\" data-end=\"3024\" data-is-last-node=\"\" data-is-only-node=\"\">The Clinical Trials Subcommittee will continue to work on issues arising from the implementation of the new regulations and maintain dialogue with the Ministry of Health of Ukraine and the State Expert Center to further improve the clinical trials system in Ukraine.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Following the working meeting held on 18 June 2026 between members of the European Business Association\u2019s Clinical Trials Subcommittee and representatives of the State Expert Center of the Ministry of Health of Ukraine, the Association requested confirmation of its understanding of certain clarifications provided during the discussion and submitted a number of additional questions requiring [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":764010,"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 - 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