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Появился список дженериков, производителям которых не нужно предоставлять результаты исследования биоэквивалентности
9 ноября 2020
Фото: depositphotos.com
Выпуск: №202, ноябрь 20202334 просмотров
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[NAME] => Береш Май Обзор писем РЗН
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Появился список дженериков, производителям которых не нужно предоставлять результаты исследования биоэквивалентности
Министерство здравоохранения опубликовало перечень воспроизведенных лекарственных препаратов, производителям которых не требуется подавать данные исследований биоэквивалентности и терапевтической эквивалентности по отношению к референтному ЛС. Документ опубликован 6 ноября в Государственном реестре лекарственных средств.
Напомним, что, согласно закону Об обращении лекарственных средств, для установления взаимозаменяемости лекарственных препаратов, производители воспроизведенных ЛС должны указывать в регистрационном досье информацию об исследованиях эквивалентности референтному препарату. Если в досье не указана такая информация, то данные о результатах исследования нужно предоставить в Минздрав.
Наличие таких сведений в регистрационном досье проверяет специальное экспертное учреждение «Научный центр экспертизы средств медицинского применения». По результатам анализа реестра, центр составил список из 121 торгового наименования дженериков, для которых не требуется подавать данные исследований био- и терапевтической эквивалентности для определения их взаимозаменяемости с референтным препаратом, поскольку они уже присутствуют в составе досье.
Напомним, что списком взаимозаменяемых ЛС, который составляется после проведения такой экспертизы, должны пользоваться врачи при назначении ЛС для лечения, а также работники аптек при консультации клиентов о наличии аналогов в рамках одного МНН.
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