13:11 23.01.2021

Biolik does not provide materials for examination, registration of Sputnik V vaccine – State Expert Center

2 min read
Biolik does not provide materials for examination, registration of Sputnik V vaccine – State Expert Center

The pharmaceutical company JSC Biolik (Kharkiv) filed an application on January 6 for registration of the Gam-COVID-Vac (Sputnik V) vaccine against coronavirus (COVID-19) disease produced by the Gamaleya Research Institute of Epidemiology and Microbiology (Russia) through the Health Ministry, but the applicant did not provide materials for the examination as of January 22.

The State Expert Center of the Health Ministry told Interfax-Ukraine about it.

The State Expert Center said that after submitting an application to the Health Ministry, the applicant has 90 days to provide the materials of the registration file to the State Expert Center for examination, which will be carried out within five days, in accordance with the procedure provided for the registration of drugs to counteract the spread of COVID-19.

"Thus, if the applicant submits materials of the registration file to the State Expert Center, their examination will be carried out within the time period established by the legislation," the State Expert Center told Interfax-Ukraine.

The State Expert Center said that if the applicant fails to provide the registration file within 90 days from the date of submission of the application, it, according to the current legislation, will be automatically canceled. After that, the applicant can re-apply for registration.

At the same time, the State Expert Center said that on December 29, 2020, the law of Ukraine on amendments to certain legislative acts of Ukraine aimed to prevent occurrence and spread of the coronavirus disease (COVID-19) came into force, according to which the examination of any drugs against COVID-19, including vaccines, takes place at the State Expert Center for five days.

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