In addition to bringing an effective and safe coronavirus vaccine into Ukraine, the issue of its registration remains no less important. The head of the Center, Mykhailo Babenko, commented on the procedural issues to “Interfax-Ukraine” and provided clarifications on the possible timeframes.
The timeframe for expert evaluation of registration dossier materials for vaccines, depending on the procedure under which they are submitted to the Center, is from 7 to 210 working days. If a vaccine has been licensed by the European Medicines Agency or has passed the WHO prequalification procedure, the registration period at the Center is no more than 45 working days.
Mykhailo Babenko stressed that registration of a coronavirus vaccine under a simplified procedure is possible only within the framework of shortened timelines during the expert evaluation. A product registered through the centralized procedure by a competent authority of the European Union (EMA) or in countries with a strict regulatory policy is registered within 10 days.
“In any case, the applicant chooses on their own under which procedure to submit the registration dossier materials for expert evaluation. For its part, the Center will promptly review all materials within the shortest possible time,” said Mykhailo Babenko.
More details at the link
