Катрен Стиль
Утвержден порядок регистрации препаратов для обращения в ЕАЭС
Министерство здравоохранения утвердило регламент по регистрации препаратов, предназначенных для обращения на общем рынке ЛС в рамках Евразийского экономического союза. Соответствующий приказ № 23н от 25.01.19 зарегистрирован в Минюсте и опубликован 15 марта.
В регламенте содержится полный перечень документов, которые необходимо подать заявителю для получения регистрации. Перечислены случаи, когда в регистрации препарата может быть отказано или когда она может быть приостановлена.
Во многом приказ базируется на действующем административном регламенте по предоставлению государственной услуги по регистрации лекарственных препаратов для медицинского применения (приказ Минздрава от 21.09.2016 № 725н).
Основные различия состоят в использовании нормативной базы Евразийского экономического союза, а также сроках, которые будут занимать процедуры, связанные с регистрацией. Срок регистрации и экспертизы лекарственного препарата по регламенту не должен превышать 210 календарных дней, срок внесения изменений в поданные документы — 90 дней, срок перерегистрации препарата — не более 120 дней.
Приказ вступит в силу 25 марта 2019 года.
Ранее в ЕАЭС было принято Руководство по выбору торговых наименований для препаратов, готовящихся к регистрации и обороту на рынке внутри Союза.
19 марта 2019
Фото: depositphotos.com
Выпуск: №182, март 20191519 просмотров
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