Росздравнадзор пояснил процедуру введения ЛС в оборот по новым правилам
2 декабря 2019
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№191, декабрь 2019
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Росздравнадзор пояснил процедуру введения ЛС в оборот по новым правилам
Федеральная служба по надзору в сфере здравоохранения дала разъяснения по новому порядку ввода лекарственных препаратов в оборот. Ведомство пояснило, как производители должны подавать данные о своих ЛС в информационную систему по новым правилам. Информационное письмо Росздравнадзора опубликовано 29 ноября.
Напомним, что с 28 ноября в России изменилась процедура ввода в обращение лекарственных препаратов. Начиная с этой даты, производителям больше не требуется получение сертификатов соответствия и регистрации деклараций о соответствии.
В информационном письме Росздравнадзор дает ряд пояснений об особенностях внесения сведений в Автоматизированную информационную систему (это необходимо, чтобы лекарственный препарат мог поступить в оборот). Например, ведомство уточняет, что в АИС необходимо указывать 14‑значный GTIN, чтобы обеспечить взаимодействие системы Росздравнадзора и системы Мониторинга движения лекарственных препаратов.
Также в документе отмечается, что для фармацевтических субстанций сохраняется ввод данных в объеме, предусмотренном приказом Росздравнадзора от 07.08.2015 № 5539. Для лекарственных препаратов (за исключением иммунобиологических) вход в систему Росздравнадзора осуществляется по ссылке на сайте Росздравнадзора.
Для получения разрешения на ввод в гражданский̆ оборот иммунобиологического лекарственного препарата необходимо заполнить электронную форму подачи заявления на получение государственной̆ услуги с использованием Единой̆ системы идентификации и аутентификации (ЕСИА).
Также Росздравнадзор напоминает, что внесение в систему сведений в ручном режиме невозможно. Поэтому если данные производителя или импортера не совпадают с информацией, указанной в государственном реестре лекарственных средств, или необходимые данные отсутствуют, то компании-производителю (или импортеру) необходимо сообщить об этом в техническую поддержку ведомства по адресу: [email protected]
Катрен Стиль
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