Минздрав представил новый порядок определения взаимозаменяемости ЛС
20 февраля 2020
Фото: depositphotos.com
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№193, февраль 2020
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Минздрав представил новый порядок определения взаимозаменяемости ЛС
Ведомство разработало обновленный алгоритм определения взаимозаменяемости лекарственных препаратов, который придет на смену Постановлению Правительства от 28 октября 2015 г. № 1154. Проект новых правил опубликован 19 февраля на портале нормативных актов.
В конце прошлого года Государственная дума приняла поправки в Федеральный закон № 61‑ФЗ «Об обращении лекарственных средств», которые дали производителям возможность не доказывать биоэквивалентность уже зарегистрированных ЛС при определении взаимозаменяемости препаратов. Также поправки позволили автоматически признавать воспроизведенные и биоаналоговые препараты взаимозаменяемыми с референтными ЛС.
В связи с принятием этого закона требуется создание нового порядка признания лекарственных препаратов взаимозаменяемыми, который бы отразил все нововведения.
Проект новых правил устанавливает, что он будет действовать для определения взаимозаменяемости всех ЛС, зарегистрированных до 1 марта 2020 года, если их взаимозаменяемость не была определена по старым правилам.
Также до 1 июля 2020 года на сайте Минздрава должен быть опубликован перечень взаимозаменяемых препаратов, который будет регулярно обновляться по мере регистрации новых ЛС или внесения изменений в регистрационные документы.
Взаимозаменяемость препаратов будет определяться на основе заключения комиссии экспертов в рамках одного международного непатентованного (или химического, или группировочного) наименования. Исключением станут гомеопатические и растительные лекарственные препараты. На них правила определения взаимозаменяемости действовать не будут.
Катрен Стиль
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