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Business welcomes the extension of the “emergency use” procedure for the authorization of drugs against COVID-19

03/ 11/ 2021
  On November 2, 2021, the Verkhovna Rada of Ukraine adopted as a basis and as a whole draft law №6121 on amendments to Article 9-2 of the Law of Ukraine On Medicinal Products regarding the emergency use authorization. The adopted draft law expands the already existing authorization mechanism for medicines used in the treatment of COVID-19. Currently, the emergency use authorization procedure can only be applied to vaccines for the prevention of COVID-19. Experts from the EBA Health Care Committee note that countries with strict regulatory systems have already granted permits for the emergency use of certain drugs for the treatment of COVID-19, as well as conducting clinical trials of drugs that could potentially obtain such a permit. Moreover, according to the Ministry of Health of Ukraine, these drugs are already available in Ukraine as part of humanitarian aid. Thus, the draft law will provide a complete mechanism for the accelerated arrival of relevant drugs to Ukraine, so that Ukrainians can receive the most advanced treatment in a global pandemic. The EBA Health Care Committee thanks the MPs of Ukraine, the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance, and the Ministry of Health of Ukraine for their hard work in overcoming the COVID-19 pandemic in Ukraine.

On November 2, 2021, the Verkhovna Rada of Ukraine adopted as a basis and as a whole draft law №6121 on amendments to Article 9-2 of the Law of Ukraine “On Medicinal Products” regarding the emergency use authorization”.

The adopted draft law expands the already existing authorization mechanism for medicines used in the treatment of COVID-19. Currently, the emergency use authorization procedure can only be applied to vaccines for the prevention of COVID-19. Experts from the EBA Health Care Committee note that countries with strict regulatory systems have already granted permits for the emergency use of certain drugs for the treatment of COVID-19, as well as conducting clinical trials of drugs that could potentially obtain such a permit. Moreover, according to the Ministry of Health of Ukraine, these drugs are already available in Ukraine as part of humanitarian aid.

Thus, the draft law will provide a complete mechanism for the accelerated arrival of relevant drugs to Ukraine, so that Ukrainians can receive the most advanced treatment in a global pandemic.

The EBA Health Care Committee thanks the MPs of Ukraine, the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance, and the Ministry of Health of Ukraine for their hard work in overcoming the COVID-19 pandemic in Ukraine.

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