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Ukrainian legislation on preclinical studies and clinical trials

29.08.2019 Updated 30.06.2026 45327 views
MoH order of 23.09.2009 No. 690 "On approval of the Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials and the Model Regulations on ethics committees" as amendedDOCX · 98 KB · 05.06.2023
Download MoH of Ukraine order of 23.09.2009 No. 690 “On approval of the Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials and the Model Regulation on ethics committees”, as amended (DOCX, 98 KB)
MoH of Ukraine order No.1169 of 26 September 2017 'Medicinal products. Good Clinical Practice 42-7.0:2008'DOC · 767 KB · 25.01.2021
Download MoH of Ukraine Order No.1169 of 26 September 2017 'Medicinal Products. Good Clinical Practice 42-7.0:2008' (DOC, 767 KB)
MoH order No. 944 of 14 December 2009 ‘On Approval of the Procedure for Conducting Preclinical Study of Medicinal Products and Expert Evaluation of Preclinical Study Materials of Medicinal Products’DOC · 36 KB · 25.01.2021
Download MoH of Ukraine Order No. 944 of 14 December 2009 'On Approval of the Procedure for Conducting Preclinical Study of Medicinal Products and Expert Evaluation of Preclinical Study Materials of Medicinal Products' (DOC, 36 KB)
Procedure for conducting preclinical study of medicinal products and expert evaluation of preclinical study materials of medicinal productsDOC · 243 KB · 25.01.2021
Download Procedure for conducting preclinical studies of medicinal products and expert evaluation of materials of preclinical studies of medicinal products (DOC, 243 KB)
MoH of Ukraine order of 23.09.2009 No. 690 “On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulation on Ethics Committees,” as amended, and its annexes.DOCX · 105 KB · 30.06.2026
Download MoH Order of 23.09.2009 No. 690 "On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees", as amended, and its annexes. (DOCX, 105 KB)
FORM of Application of the Responsible InvestigatorDOC · 44 KB · 30.06.2026
Download FORM of the Statement of the Responsible Investigator (DOC, 44 KB)
Information on healthcare facilities and the clinical trial siteDOCX · 22 KB · 30.06.2026
Download Information on the healthcare institution and the clinical trial site (DOCX, 22 KB)
FORM Notification of the start of clinical trials in UkraineDOCX · 20 KB · 30.06.2026
Download FORM Notification of the start of a clinical trial in Ukraine (DOCX, 20 KB)
FORM of the Application for a clinical trial of a medicinal productDOCX · 67 KB · 30.06.2026
Download FORM of Application for conducting a clinical trial of a medicinal product (DOCX, 67 KB)
FORM of the Cover letter to the application for a clinical trial of a medicinal productDOCX · 21 KB · 30.06.2026
Download FORM of the Cover letter to the application for conducting a clinical trial of a medicinal product (DOCX, 21 KB)
FORM of Application for a Substantial AmendmentDOCX · 23 KB · 30.06.2026
Download FORM of the Application for a Substantial Amendment (DOCX, 23 KB)
FORM of the Cover Letter on Substantial AmendmentsDOCX · 13 KB · 30.06.2026
Download Cover Letter FORM for Substantial Amendments (DOCX, 13 KB)
FORM of the Periodic Report on the Status of a Clinical Trial in UkraineDOCX · 21 KB · 30.06.2026
Download FORM of the Periodic Report on the Status of a Clinical Trial in Ukraine (DOCX, 21 KB)
FORM Notification of completion of a clinical trialDOCX · 20 KB · 30.06.2026
Download FORM Notification of completion of a clinical trial (DOCX, 20 KB)

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# Заявникам # Експертиза матеріалів доклінічних та клінічних випробувань # Накази МОЗ про проведення КВ / СП
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List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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Registration certificates to order No. 1340
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