Adopted the Law of Ukraine "On Amendments to Article 9-2 of the Law of Ukraine 'On Medicinal Products' Concerning State Registration of Medicinal Products Under Obligations" (No. 6121).
The Law provides for the possibility of emergency medical use of certain drugs, vaccines or other medical immunobiological products intended for the treatment and / or specific prevention of Coronavirus disease (COVID-19), in the procedure of state registration under the obligation if the applicant can prove that he does not have the capacity to provide complete data on the efficacy and safety of the medicinal product, vaccine or other medical immunobiological product under normal conditions of use for objective reasons.
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The Law provides for the possibility of emergency medical use of certain drugs, vaccines or other medical immunobiological products intended for the treatment and / or specific prevention of Coronavirus disease (COVID-19), in the procedure of state registration under the obligation if the applicant can prove that he does not have the capacity to provide complete data on the efficacy and safety of the medicinal product, vaccine or other medical immunobiological product under normal conditions of use for objective reasons.
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