Verkhovna Rada could allow emergency use of vaccines before third stage of clinical trials

Source : 112 Ukraine

Thanks to the adoption of this law, Ukraine can expect to receive the first batches of vaccine in early February
12:15, 28 January 2021


Verkhovna Rada upheld in the first reading bill #4613 on amendments to the Law “On medicines” stipulating state registration of medicines under the obligations to open opportunities for registration of vaccines from Covid-19.

The parliamentary session was broadcasted by 112 Ukraine TV channel.

Chairman of the committee Mykhailo Radutsky on his Facebook page noted that this document will allow the use of vaccines produced in Ukraine by such companies as Pfizer / BioNTech, Sinovac Biotech, Moderna, Sinopharm, AstraZeneca.

“To this date, no vaccine from Covid-19 has passed a full cycle of clinical trials. Vaccinations in the EU, the United States, and other countries began in emergency use. Ukrainian legislation does not provide for such a regime. Therefore, for the registration of vaccines in our country there is a need to make changes to the legislation,” Radutsky wrote.

The document provides for the possibility of registration of vaccines in Ukraine and using it if there is evidence of successful preclinical trials, if clinical trials were conducted with the permission of the relevant competent authorities of the United States, Great Britain, Swiss Confederation, Japan, Australia, Canada, China, India or European Union (at least one of these countries) in accordance with the national legislation of the country of authorization or if the medicinal product was reclassified by the World Health Organization.

In such circumstances, the vaccine may be registered for emergency medical use during the time an applicant completes the clinical trials.

Related: Ukraine’s government simplifies purchase of drugs, vaccines

Earlier, Servant of the People MP Oleksandr Kornienko noted that thanks to the adoption of this legislation, Ukraine can to count on receiving the first batches of the vaccine in early February.

Earlier, Ukraine's Health Minister announced when Ukraine to get the anti-Covid-19 vaccine.

On December 4, 2020, Ukrainian parliament adopts law on accelerated access to Covid-19 vaccine.

Related: Ukraine not to get large-scale access to vaccine against Covid-19 until 2023, - media

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