of November 2, 2021 No. 1843-IX
About introduction of amendments to article 9-2 of the Law of Ukraine "About medicines" rather state registration of medicines under obligations
The Verkhovna Rada of Ukraine decides:
1. Article 9-2 of the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86; 2021, No. 16, Art. 146; with the changes made by the Law of Ukraine of March 19, 2021 No. 1353-IX) to state in the following edition:
"Article 9-2. Features of state registration of medicines under obligations for the emergency medical application and vaccines or other medical immunobiological supplies for specific prevention under obligations for the emergency medical application
1. Due to the distribution of pandemic of koronavirusny disease (COVID-19) for possibility of the emergency medical application of separate medicines, vaccines or other medical immunobiological supplies for the period of action of emergency situation and/or quarantine according to the procedure established by the Cabinet of Ministers of Ukraine, such medicine, vaccine or other medical immunobiological supply for treatment and/or specific prevention of koronavirusny disease (COVID-19) can be subject to the accelerated state registration in case of acceptance by the central executive body which provides forming and realizes state policy in the field of health care, decisions on state registration of medicine, vaccine or other medical immunobiological supply for treatment and/or specific prevention of koronavirusny disease (COVID-19) for the purpose of the emergency medical application taking into account certain obligations if the applicant can prove that it has no opportunities for provision of complete data about efficiency and safety of medicine, vaccine or other medical immunobiological supply for treatment and/or specific prevention of koronavirusny disease (COVID-19) under normal conditions of application for the objective reasons and if:
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