Resolution of the Cabinet of Ministers of Ukraine of December 29, 2021 No. 1446 Certain issues of state registration of medicinal products, vaccines, or other medical immunobiological preparations for the treatment and/or specific prevention of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2, under obligation for emergency medical use – State Expert Center of the Ministry of Health of Ukraine

PROCEDURE for the state registration of medicinal products, vaccines or other medical immunobiological products for treatment and/or specific prevention of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2 subject to obligations for emergency medical useDOCX · 24 KB · 22.10.2026

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ANNEX 1: Application for state registration of medicinal product, vaccine or other medical immunobiological product subject to obligations for emergency medical useDOCX · 19 KB · 22.10.2026

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ANNEX 2: Opinion based on the results of expert assessment of the benefit/risk balance and authenticity verification of registration materials for a medicinal product, vaccine or other medical immunobiological product subject to obligations for emergency medical useDOCX · 19 KB · 22.10.2026

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ANNEX 3: Registration certificate for medicinal product (medical immunobiological product) for emergency medical useDOCX · 20 KB · 22.10.2026

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ANNEX 4: Application for state registration of vaccine or other medical immunobiological product for specific prevention of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2, which has a full production cycle or manufactured from 'in bulk' in Ukraine, subject to obligations for emergency medical useDOCX · 17 KB · 22.10.2026

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ANNEX 5: Opinion based on the results of expert assessment of the benefit/risk balance, expert evaluation of registration materials and results of quality control of vaccine or other medical immunobiological product for specific prevention of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2, which has a full production cycle or is manufactured from 'in bulk' in Ukraine, subject to obligations for emergency medical useDOCX · 17 KB · 22.10.2026

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