Елена Самтынова
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Правительством РФ установлены новые правила определения взаимозаменяемости лекарственных препаратов, одновременно прежний порядок признан утратившим силу. Соответствующее Постановление Правительства РФ от 5 сентября 2020 г. № 1360 вступило в силу 9 сентября.
Новый порядок раскрывает критерии, по которым должна определяться взаимозаменяемость, в том числе для отдельных видов препаратов. В частности, учитываются:
эквивалентность качественных и количественных характеристик фармсубстанций и сопоставимость антигенного состава вакцин; эквивалентность лекарственной формы (одинаковый способ введения и применения лекарства); эквивалентность и сопоставимость состава вспомогательных веществ; идентичность способа введения и применения препарата; соответствие производителя лекарства требованиям правил надлежащей производственной практики.
Определение параметров препарата, их соответствие указанным критериям осуществляется комиссией экспертов экспертного учреждения посредством сравнения нормативной документации, отчетов о проведенных исследованиях о биоэквивалентности или терапевтической эквивалентности препарата.
При этом взаимозаменяемые комбинированные препараты (содержащие два и более действующих веществ) должны быть зарегистрированы в РФ по результатам проведения исследований по эквивалентности с соответствующим референтным комбинированным препаратом или референтными препаратами, имеющими международное непатентованное наименование, входящие в состав соответствующего комбинированного препарата.
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Документ также устанавливает особенности определения взаимозаменяемости недозированных препаратов, препаратов для парентерального питания и т. д.
Утверждена форма экспертного заключения. Заключение подлежит размещению на портале по ведению государственного реестра лекарственных средств в личном кабинете держателя или владельца регистрационного удостоверения в течение трех рабочих дней со дня получения Минздравом России заключения от экспертного учреждения
Перечень взаимозаменяемых препаратов размещается на сайте Минздрава России и обновляется не реже одного раза в месяц.
Заключение экспертной комиссии может быть обжаловано держателем или владельцем регистрационного удостоверения лекарственного препарата в течение 20 дней со дня размещения заключения в личном кабинете заявителя путем подачи жалобы через личный кабинет.
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