Катрен Стиль19 ноября 2021
Фото: depositphotos.com
Выпуск: №215, ноябрь 2021743 просмотров
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Действие упрощённых правил регистрации ЛС от коронавируса продлено ещё на год
Правительство России внесло изменения в правила упрощённой регистрации ЛС, ещё на один год продлив действие регистрационных удостоверений, выданных по ускоренной процедуре. Соответствующее постановление 17.11.2021 г. № 1961 опубликовано на портале раскрытия правовой информации.
Напомним, что с прошлого года действует постановление от 3 апреля 2020 г. № 441, согласно которому срок регистрации лекарственных средств, предназначенных для применения в условиях чрезвычайной ситуации, а также для профилактики и лечения заболеваний, представляющих опасность для окружающих, может быть сокращён со 120 до 20 рабочих дней. Такие меры были предприняты для скорейшего доступа на рынок препаратов для борьбы с пандемией коронавируса COVID-19.
Для ускорения процесса регистрации производителям таких ЛС разрешено вместо подробных отчётов о результатах клинических исследований предоставить краткий отчёт об имеющихся на момент подачи заявления результатах изучения эффективности и безопасности лекарственного препарата в рамках КИ.
При этом срок действия таких «упрощённых» регистрационных удостоверений ЛС ограничен. После его истечения производители должны перерегистрировать препарат по базовым правилам, предоставив полный пакет необходимых документов.
Изначально предполагалось, что упрощённые удостоверения будут действовать до 2021 года. Затем их срок действия был увеличен ещё на один год. Теперь же удостоверения, выданные по упрощённой схеме, будут действительны до 1 января 2023 года. До этой даты также будут действовать и сами правила ускоренной регистрации.
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