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22 сентября 2020
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№200, сентябрь 2020
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Утверждены новые правила уничтожения фальсифицированных и недоброкачественных ЛС
Правительство России составило новые правила уничтожения изъятых фальсифицированных, недоброкачественных и контрафактных лекарственных средств. Документ будет действовать в период с 2021 по 2027 год. Соответствующее постановление от 15.09.2020 № 1447 опубликовано 21 сентября.
Напомним, что действующий на данный момент порядок уничтожения ЛС (Постановление Правительства от 3 сентября 2010 г. № 674) попадает под действие «регуляторной гильотины» и теряет свою силу с 1 января 2021 года.
Новые правила уничтожения практически повторяют действующее постановление, однако содержат несколько отличий. Так, со следующего года владелец недоброкачественных фальсифицированных ЛС будет обязан изъять и изолировать такие препараты в течение 30 дней после соответствующего приказа контролирующего органа, а на их уничтожение будет отведено 6 месяцев. Сейчас вся процедура от изъятия до уничтожения не может превышать 30 дней.
Кроме этого, владельцам недоброкачественных лекарственных препаратов будет разрешено самим производить их уничтожение, при наличии соответствующей лицензии на сбор, использование, обезвреживание, транспортировку и размещение отходов I–IV класса опасности. В действующих правилах недоброкачественные ЛС, подлежащие уничтожению, в любом случае необходимо передать специализированной организации.
Ранее Росздравнадзор обнаружил в обороте серию этилового спирта с признаками фальсификации — аптекам и поставщикам необходимо провести проверку на предмет подделки всех имеющихся в ассортименте серий этого лекарственного препарата.
Катрен Стиль
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