Постанова Кабінету Міністрів України від 29 грудня 2021 р. № 1446 Деякі питання державної реєстрації лікарських засобів, вакцин або інших медичних імунобіологічних препаратів для лікування та/або специфічної профілактики гострої респіраторної хвороби COVID-19, спричиненої коронавірусом SARS-CoV-2, під зобов’язання для екстреного медичного застосування

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 use
ANNEX 1: Application for state registration of medicinal product, vaccine or other medical immunobiological product subject to obligations for emergency medical use
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 use
ANNEX 3: Registration certificate for medicinal product (medical immunobiological product) for emergency medical use
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 use
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 use