Russia's COVID-19 Vaccine For Animals Can Become 1st Such Drug Approved In EU - EMA
Mohammad Ali (@ChaudhryMAli88) Published April 15, 2021 | 03:08 PM
Russia's coronavirus vaccine for animals can become the first vaccine of this type approved in the European Union, since the bloc's drug regulator currently has no such vaccines under evaluation, the European Medicines Agency (EMA) told Sputnik on Thursday, adding that evaluation can take up to 210 days
BRUSSELS (UrduPoint News / Sputnik - 15th April, 2021) Russia's coronavirus vaccine for animals can become the first vaccine of this type approved in the European Union, since the bloc's drug regulator currently has no such vaccines under evaluation, the European Medicines Agency (EMA) told Sputnik on Thursday, adding that evaluation can take up to 210 days.
In late March, Russia registered the first vaccine against COVID-19 for animals. The Carnivac-Cov vaccine was developed by the Federal Center for Animal Health. It is already available for orders.
"At the moment, no COVID-19 vaccines for animals are under evaluation by EMA. Developers of COVID-19 vaccines for animals can submit an application for a marketing authorisation in the EU if the applicant is established in the EU (e.
g. have a subsidiary in a EU Member State). They would also need to adhere to the EU standards and requirements for quality, safety and efficacy," EMA said.
The evaluation process may take up to 210 days, it is interrupted after day 120 and possibly also after day 180 by a so-called "clock stop" period, during which the company prepares answers to questions from the EMA's Committee for Medicinal Products for Veterinary Use, the regulator explained.
"Clock stops can be of variable duration - depending on the questions raised and the time needed by applicants to prepare their responses - and do not count towards the 210 evaluation days," EMA specified.
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