LAW OF UKRAINE

of January 29, 2021 No. 1159-IX

About modification of the Law of Ukraine "About medicines" rather state registration of medicines under obligations for the emergency medical application

The Verkhovna Rada of Ukraine decides:

I. "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, of Art. 86 with subsequent changes) to add the Section II of the Law of Ukraine with Article 9-2 of the following content:

"Article 9-2. Features of state registration of vaccines or other medical immunobiological supplies for specific prevention of koronavirusny disease (COVID-19) 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 vaccines or other medical immunobiological supplies for specific prevention of koronavirusny disease (COVID-19) according to the procedure of state registration under obligations established by the Cabinet of Ministers of Ukraine such vaccines or other medical immunobiological supplies 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 vaccines or other medical immunobiological supplies for the purpose of the emergency medical application taking into account certain obligations, if the applicant can prove lack at it of opportunities for provision of data in full on efficiency and safety of vaccines or other medical immunobiological supplies under normal conditions of application for the objective reasons and if:

1) there are data on successful carrying out preclinical testing / researches, separate phases of clinical testing / researches and the received results contain in total evidence-based proofs, including data of adequate and well controlled researches which allow to consider that vaccines or other medical immunobiological supplies can be effective for prevention of koronavirusny disease (COVID-19);

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