Представлен новый порядок определения взаимозаменяемости лекарственных средств
21 августа 2019
Фото: depositphotos.com
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№187, август 2019
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Представлен новый порядок определения взаимозаменяемости лекарственных средств
Министерство здравоохранения составило новые правила по определению взаимозаменяемости лекарственных препаратов. Они придут на смену действующему порядку, утвержденному Постановлением Правительства № 1154 от 28 октября 2015 года. Проект документа опубликован 20 августа на портале проектов нормативных актов.
В соответствии с новым порядком, взаимозаменяемость ЛС будут оценивать экспертные учреждения путем сравнения препарата с референтным по нескольким параметрам:
— эквивалентности качественных и количественных характеристик субстанции, лекарственной формы и вспомогательных веществ;
— идентичности способа введения и применения;
— соответствию производителя требованиям правил надлежащей производственной практики.
Сравнение будет проходить путем сверки сведений, содержащихся в нормативных документах на препарат: регистрационном досье, отчетах о проведенных исследованиях по терапевтической эквивалентности и инструкциях по применению. При этом если в инструкциях у взаимозаменяемых препаратов будут обнаружены различия в показаниях к применению или противопоказаниях, то производители в течение шести месяцев должны будут внести изменения в документ, чтобы он соответствовал инструкции по применению референтного препарата.
Также взаимозаменяемыми будут автоматически признаны воспроизведенные биоаналоги (по отношению к референтному ЛС) и фармацевтически эквивалентные препараты с одним МНН.
Напомним, что уточнить порядок взаимозаменяемости лекарственных препаратов правительству и министерствам поручил президент России в июле прошлого года. Также ранее представители Федеральной антимонопольной службы заявляли, что наличие четких правил по взаимозаменяемости ЛС должно помочь отечественным производителям при госзакупках.
Катрен Стиль
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