Депутаты приняли новый закон, который усилит контроль за качеством ЛС
22 ноября 2018
Фото: depositphotos.com
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№178, ноябрь 2018
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Депутаты приняли новый закон, который усилит контроль за качеством ЛС
20 ноября Госдума приняла в третьем, окончательном чтении законопроект, который ужесточает порядок ввода в оборот впервые произведенных в России и впервые импортированных лекарственных препаратов. Информация об этом опубликована на официальном сайте Государственной думы.
Законопроект предусматривает, что перед вводом в оборот серии или партии ЛС, произведенных в России, производитель должен будет предоставить в орган исполнительной власти документ, подтверждающий качество лекарственного препарата и его соответствие требованиям, установленным при регистрации.
Помимо этого, при ввозе в Россию партии или серии препарата компания-импортер должна будет предоставить документ о соответствии ЛС требованиям фармакопейной статьи или регистрационным требованиям, если соответствующая фармакопейная статья отсутствует. Эти правила не касаются иммунобиологических лекарственных препаратов.
Кроме этого, для первых трех серий впервые произведенного в России или впервые ввезенного на территорию РФ препарата, необходимо будет предоставлять протокол испытаний на предмет соответствия этой партии или серии нормативной документации. При этом выполнять такие испытания должны специально аккредитованные бюджетные учреждения. Также подобные протоколы об испытаниях необходимо будет предоставлять ежегодно для одной серии каждого препарата, поступившего в оборот в течение года.
Катрен Стиль
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