The Verkhovna Rada has registered the draft law of Ukraine “amending certain legislative acts of Ukraine concerning the provision of treatment against coronaviruses (Covid-19)”.
The corresponding document is available on the Verkhovna Rada website.
“It is advisable to introduce in Ukraine the practice of using drugs registered according to indications not included in the approved instructions for use, as one of the ways to solve the problem of the availability of pharmacotherapy for the period of the Covid-19 coronavirus disease epidemic, “said the bill’s explanatory note.
It should be noted that questions of analysis of evidence and, therefore, decision-making regarding the possibility of using registered medicines for indications not included in the approved instructions for use, it would be desirable to combine with the ” development of medical and technological documents for the standardization system (clinical guidelines and medical care protocols).
The bill was drafted with the aim of preventing the spread of Covid-19 coronavirus disease among the population of Ukraine and creating a legal basis for the rapid implementation by the state of a set of measures measures to prevent and treat coronavirus disease (Covid-19).
In particular, the bill will allow the use of unregistered drugs recommended by the official body of the United States of America, member countries of the European Union, Great Britain, the Swiss Confederation, the Japan, Australia, Canada and the Chinese people for the treatment of a person with coronavirus confirmed by laboratory tests Republic, the State of Israel for the treatment of coronavirus disease, as well as drugs registered, if indicated, not indicated annym in the instructions for use in the presence of proven efficacy in the treatment of coronavirus diseases and / or recommended by an official American body, the countries – members of the EU, the United Kingdom , the Swiss Confederation, Japan, Australia, Canada, China, Israel, for the treatment of coronavirus diseases in the country. The procedure for the appointment and use of these drugs within a week should be established by the Ministry of Health of Ukraine.
In addition, the bill provides for the approval of protocols for clinical trials of drugs for the treatment of coronaviruses and significant changes to the latter up to 5 calendar days, as well as the review of registration documents and documents concerning changes to registration documents of drugs for the treatment of coronavirus diseases, conditions for filing registration documents and documents concerning changes to registration documents stated and Ukrainian or English, up to 5 calendar days.
The document also provides for the adoption of decisions on state registration or the refusal of state registration of these medicines within a period not exceeding two working days from the date of receipt by the Ministry of Health of Ukraine conclusions regarding the quality, safety and efficacy of medicines compiled by the State Enterprise State Expert Center of the Ministry of Health of Ukraine “according to the results of the examination of registration documents (dossier registration) prov material evaluation of clinical trials of drugs for the treatment of coronavirus disease and their significant modifications up to 5 calendar days.
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The bill also provides for the implementation by the Ministry of Health of Ukraine of an urgent and continuous updating of medical care protocols for the treatment of coronaviruses, drugs for the treatment of coronaviruses and control the safety and efficacy of drugs for the treatment of coronaviruses.
As Ukrinform reported, at 10:00 p.m. on March 29 in Ukraine, 475 laboratory-confirmed PCR studies on Covid-19 cases.
According to the materials: ukrinform.ru