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Clinical trials

06.05.2021 Updated 30.06.2026 125689 views

Laws of Ukraine

Law of Ukraine “On Medicinal Products” of April 4, 1996 No. 123/96-VRDOCX · 79 KB · 22.10.2026
Download Law of Ukraine "On Medicinal Products" of April 4, 1996 No. 123/96-VR (DOCX, 79 KB)

Orders of the Ministry of Health of Ukraine

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, MoH order of 23 September 2009 No. 690 (as amended by the order of the Ministry of Health of Ukraine of 12 July 2012 No. 523)DOCX · 152 KB · 22.10.2026
Download 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, MoH order of 23 September 2009 No. 690 (as amended by the order of the Ministry of Health of Ukraine of 12 July 2012 No. 523) (DOCX, 152 KB)
On Approval of the Regulations on the Council for the Development and Implementation of Good Manufacturing (GMP), Distribution (GDP), Laboratory (GLP), and Clinical (GCP) Practices and the Program for the Development and Phased Implementation of Good Practices, order of the Ministry of Health of Ukraine of 4 April 2007 No. 162DOCX · 36 KB · 22.10.2026
Download On approval of the Regulations on the Council for the Development and Implementation of Good Manufacturing (GMP), Distribution (GDP), Laboratory (GLP) and Clinical (GCP) Practices and the Program for the Development and Phased Implementation of Good Practices, order of the Ministry of Health of Ukraine of 4 April 2007 No. 162 (DOCX, 36 KB)
On approval of documents on quality assurance of medicinal products, order of the Ministry of Health of Ukraine of 16 February 2009 No. 95DOCX · 1.4 MB · 22.10.2026
Download On approval of documents on quality assurance of medicinal products, order of the Ministry of Health of Ukraine of 16 February 2009 No. 95 (DOCX, 1.4 MB)
FORM of Application of the Responsible InvestigatorDOC · 44 KB · 22.10.2026
Download FORM of the Statement of the Responsible Investigator (DOC, 44 KB)
Information on healthcare facilities and the clinical trial siteDOCX · 22 KB · 22.10.2026
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 · 22.10.2026
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 · 22.10.2026
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 · 22.10.2026
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 · 22.10.2026
Download FORM of the Application for a Substantial Amendment (DOCX, 23 KB)
FORM of the Cover Letter on Substantial AmendmentsDOCX · 13 KB · 22.10.2026
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 · 22.10.2026
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 · 22.10.2026
Download FORM Notification of completion of a clinical trial (DOCX, 20 KB)
Useful resources
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Registration certificates to order No. 1583
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