The Committee on Public Health, Medical Assistance and Medical Insurance considered the draft Law No. 4613 “On Amendments to the Law of Ukraine ‘On Medicinal Products’ regarding the state registration of medicinal products under the obligation.”
Mykhailo Radutskyi, Chairperson of the Committee on Public Health, Medical Assistance and Medical Insurance and one of the authors of the bill, said: “The development of this law is due to the need to begin vaccination of our citizens against coronavirus infection as soon as possible.” He also said that for objective reasons, no vaccine developed in the world from COVID-19 has passed the full cycle of tests. Vaccinations in the EU, USA and other countries have started in emergency use regime. At the same time, Ukrainian legislation does not provide for such a regime. Therefore, there is a need for legislative changes to register vaccines in Ukraine. European law provides for the so-called registration under the obligation. “This procedure allows them to respond quickly to threatening situations and use medicines for treatment at the same time as completing certain stages of clinical trials,” said Mykhailo Radutskyi.
The bill proposes to introduce into national law a rule similar to European legislation on the registration of medicinal products under the obligation. At the same time, it is proposed to allow such a procedure to be applied only to medicines that have undergone clinical trials in countries such as the United States, Great Britain, Switzerland, Japan, Australia, Canada, China, Israel, India, Mexico, Brazil or the European Union.
During the discussion, MP Olga Stefanyshyna proposed to change the approach by which the Government can register the vaccine under the obligation. The MP proposes to focus not on the country where the clinical trials were conducted, but to register the vaccine, which already has a permit for emergency use in at least one of the defined list of countries.
After a long discussion, which was attended by representatives of the Ministry of Health, the National Security and Defense Council and the State Expert Center of the Ministry of Health of Ukraine, it was determined that the medicine may be subject to accelerated state registration if: “emergency authorization has been granted by the competent authorities of one of the following countries: the United States of America, the United Kingdom, the Swiss Confederation, Japan, Australia, Canada, the People's Republic of China, India or the European Union.”
The Committee decided to recommend to include the draft law in the agenda and, based on the results of the first reading, to adopt it as a basis and in general, taking into account the proposals submitted by the Committee.
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