The Ministry of Health of Ukraine is negotiating with the U.S. company Moderna regarding the authorization of a vaccine against coronavirus (COVID-19) in Ukraine, the ministry's press service told Interfax-Ukraine.
"In order to register a medicine, a vaccine manufacturer must apply to a government regulator with a relevant application for public authorizaton. Such a norm is valid not only in Ukraine, but also in the EU countries, the United States and during the re-qualification of the medicine by the World Health Organization. The ministry is negotiating with the manufacturer so that this the vaccine has been authorized in Ukraine," the ministry said.
The Health Ministry said that, according to the current legislation, unauthorized medicines can be used in case of an emergency.
"Considering that the vaccine was approved for emergency use by regulators of WHO, the United States and Europe, the ministry decided, if this medicine is received, as humanitarian aid, to allow vaccination against COVID-19 in Ukraine. According to the current legislation, we have the right to use medicines unauthorized in Ukraine in case of an emergency," the ministry said.
In addition, according to the statement, Ukraine has a powerful pharmacovigilance system harmonized with international standards. Pharmacovigilance for the safety of vaccines against COVID-19 in Ukraine is regulated by the pharmacovigilance procedure, the vaccination roadmap and the procedure for prescribing and using medicines for the treatment of COVID-19, approved by Health Ministry decision No. 1482 dated June 30, 2020.