Минздрав представил порядок усиления контроля за качеством ЛС
4 апреля 2019
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№183, апрель 2019
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Минздрав представил порядок усиления контроля за качеством ЛС
Ведомство опубликовало проект постановления, в котором перечислены документы, которые производители должны предоставлять в Росздравнадзор перед вводом в оборот каждой серии лекарственного препарата. Документ опубликован 4 апреля на портале проектов нормативных актов.
Согласно принятому Госдумой в прошлом году закону, фармкомпании перед вводом в оборот серии или партии ЛС обязаны предоставить в Росздравнадзор документ, подтверждающий качество лекарственного препарата и его соответствие требованиям, установленным при регистрации. В настоящий момент требований к таким документам и к тому, как они должны подаваться, нет, поскольку исполнение закона станет обязательным только с 29 ноября 2019 года.
Именно для этого Минздрав и разработал проект порядка представления документов и сведений о ЛС, вводимых в гражданский оборот. Данные будут вноситься в автоматическую информационную систему Росздравнадзора. Для ввода серии в обращение необходимо будет предоставить сведения о препарате, а также документ, подтверждающий соответствие требованиям нормативной документации и регистрационным требованиям.
Если на рынок поступает впервые произведенный препарат (или впервые ввезенный в Россию), то для первых трех серий необходимо дополнительно предоставить протоколы клинических испытаний, проведенных в аккредитованных Минздравом организациях.
В качестве дополнительной меры контроля за соблюдением этих требований министерство разработало проект постановления, которое разрешит Росздравнадзору отзывать из обращения серии лекарств, для которых не были поданы необходимые документы.
Напомним, что ранее Минздрав утвердил новый порядок приостановления применения ЛС в России, расширяющий список причин, по которым тот или иной препарат может быть изъят из оборота.
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