Катрен Стиль
Вступил в силу закон о взаимозаменяемости ЛС
1 марта вступил в силу Федеральный закон от 27.12.2019 № 475‑ФЗ «О внесении изменений в Федеральный закон «Об обращении лекарственных средств» и Федеральный закон «О внесении изменений в Федеральный закон «Об обращении лекарственных средств».
Новый нормативно-правовой акт ввел понятия «терапевтически эквивалентные» и «фармацевтически эквивалентные» лекарственные препараты, а также изменил существующие определения оригинального и референтного препаратов.
«Оригинальным» теперь называется препарат с новым действующим веществом, который был зарегистрирован в любой стране мира первым и появился на рынке раньше. «Референтный препарат» — это ЛС, которое используется для оценки биоэквивалентности или терапевтической эквивалентности, качества, эффективности и безопасности воспроизведенного или биоаналогового препарата.
Кроме этого, документ вносит поправки в процедуру признания лекарств взаимозаменяемыми. Теперь производители не обязаны доказывать биоэквивалентность зарегистрированных ЛС при определении взаимозаменяемости препаратов.
Также воспроизведенные или биоаналоговые препараты, зарегистрированные по результатам исследования биоэквивалентности или терапевтической эквивалентности, автоматически будут признаны взаимозаменяемыми с референтными препаратами.
Помимо этого, закон разрешает ввоз в Россию конкретных партий незарегистрированных лекарственных препаратов, содержащих наркотические средства или психотропные вещества. Делать это можно для оказания медицинской помощи по жизненным показаниям конкретного пациента в случае, если имеется решение врачебной комиссии о неэффективности или невозможности применения иных зарегистрированных лекарственных препаратов.
Напомним, что для исполнения нового закона Минздрав ранее разработал новый порядок определения взаимозаменяемости лекарственных препаратов.
5 марта 2020
Фото: depositphotos.com
Выпуск: №194, март 20208592 просмотров
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