Елена Самтынова
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Правительством РФ принято решение об упрощении порядка работы с системой мониторинга движения лекарственных препаратов. Как сообщает сайт кабинета министров, учитывая повышенный спрос на лекарства и эпидемиологическую ситуацию, упрощенный режим будет функционировать до полной готовности всех участников отрасли. Напомним, функционирование системы мониторинга движения лекарственных препаратов на сегодня регулируется специальным положением, утвержденным постановлением Правительства РФ от 14 декабря 2018 г. № 1556.
Изменения, внесенные Правительством РФ в данное постановление, касаются предоставления возможности аптекам и медучреждениям выводить лекарства из оборота через кассы и регистраторы выбытия сразу после уведомления системы о поступивших к ним препаратах, то есть, ждать подтверждения от системы, что сведения о приемке успешно зарегистрированы, не нужно. Датой представления сведений в систему мониторинга в указанных случаях теперь будет считаться дата направления сведений в систему мониторинга указанными субъектами обращения лекарственных средств. Ранее сведения об очередной операции с лекарственным препаратом необходимо было передавать после получения подтверждения об успешной обработке системой мониторинга сведений о предыдущей операции с лекарственным препаратом (поправки внесены в п. 32 Положения о системе мониторинга движения лекарственных препаратов для медицинского применения).
Также до 1 июля 2021 года вводится упрощенный механизм «обратной приемки лекарств» при их ввозе в Россию и обороте внутри страны. В частности, субъекты обращения лекарственых средств вправе не дожидаться от поставщиков подтверждения приемки препаратов и могут самостоятельно оприходовать их и проводить дальнейшие действия с лекарствами. Соответственно, при ввозе лекарств в Россию импортеры могут не ждать от держателей или владельцев регистрационного удостоверения на препараты подтверждения ввоза. Такие сведения будут подтверждаться самой системой путем проверки кода товара и данных участника, что ускорит операции для всех участников, так как снижает зависимость от задержек на стороне поставщиков лекарств.
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Кроме того, обязанность по подаче сведений в систему для участников сохраняется в полном объеме, но участник имеет право производить дальнейшие операции с товаром, если не получил из системы успешного ответа об обработке данных в течение 15 минут. Указанный порядок будет действовать до 1 февраля 2021 года. «Такой режим исключает создание «пробок» и ускоряет движение препаратов. Одновременно это дает возможность участникам более качественно подготовиться к следующим этапам внедрения системы – для исключения сложностей при работе в будущем», – следует из правительственного сообщения.
Указанные изменения порядка мониторинга лекарств распространяются на все действия с их оборотом, начиная с 1 июля текущего года, за исключением препаратов из категории 12 высокозатратных нозологий. Новый порядок вступит в силу со дня официального опубликования постановления Правительства РФ от 2 ноября 2020 г. № 1779.
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