Катрен Стиль
Разрешение на оборот незарегистрированных ЛС будет выдавать специальная комиссия
Министерство здравоохранения составило регламент работы комиссии, которая будет принимать решение о временном введении в оборот незарегистрированных лекарственных препаратов в ряде экстренных случаев. Соответствующий приказ от 21.04.2020 № 358н опубликован на портале раскрытия правовой информации.
Комиссия будет принимать заявки на возможность временного обращения серий ЛС, которые предназначены для применения в условиях угрозы, возникновения и ликвидации чрезвычайной ситуации, а также для профилактики и лечения «заболеваний, представляющих опасность для окружающих».
Перечень таких заболеваний утвержден Постановлением Правительства от 1 декабря 2004 года № 715. В него входят: чума, малярия, сибирская язва и другие опасные заболевания. В начале 2020 года в этот список также была включена коронавирусная инфекция COVID-19.
В состав комиссии войдут представители Минздрава, Минпромторга, Росздравнадзора, Федеральной таможенной службы и Научного центра экспертизы средств медицинского применения. Заседания будут проводиться по мере поступления в Минздрав заявлений на допуск в обращение незарегистрированных ЛС.
На рассмотрение будут принимать заявки на обращение препаратов, предназначенных для диагностики, патогенетического лечения или профилактики заболеваний, представляющих опасность для окружающих.
Отдельным пунктом, по которому комиссия будет оценивать поступившие предложения, является наличие в России зарегистрированных аналогов по действующему веществу и лекарственной форме.
Напомним, что ранее на фоне пандемии коронавирусной инфекции правительство в 6 раз сократило допустимые сроки регистрации новых препаратов, предназначенных для борьбы с опасными заболеваниями.
24 апреля 2020
Фото: depositphotos.com
Выпуск: №195, апрель 20201804 просмотров
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