В ФАС рассказали, как ускорить процедуру признания ЛС взаимозаменяемыми
Федеральная антимонопольная служба считает, что завершить работу по признанию взаимозаменяемости большинства лекарственных средств можно уже в 2019 году. Для этого необходимо считать взаимозаменяемыми референтный и воспроизведенный препараты. Об этом 13 октября пишет пресс-служба ведомства со ссылкой на заявление начальника Управления контроля социальной сферы и торговли Тимофея Нижегородцева.
По мнению ФАС, если какой‑либо лекарственный препарат зарегистрирован как воспроизведенный, то этот факт служит доказательством его эквивалентности референтному препарату, а, следовательно, они должны признаваться взаимозаменяемыми. Таким образом оборот препарата на рынке ФАС предлагает считать «своеобразным видом клинического исследования».
Что касается воспроизведенных ЛС, зарегистрированных в отсутствие референтного (активированный уголь, вода для инъекций), то такие препараты ФАС предлагает считать взаимозаменяемыми в рамках одного МНН с одинаковыми лекарственными формами и дозировками.
Таким образом, большинство необходимых мероприятий по признанию взаимозаменяемости лекарств можно провести уже в 2019 году, — такого мнения придерживаются в ведомстве.
Напомним, что в 2017 году Верховный суд запретил ФАС самостоятельно определять взаимозаменяемость лекарств, постановив, что правом на это могут обладать только подведомственные Министерству здравоохранения эксперты.
Разработка мер по уточнению порядка признания взаимозаменяемости лекарств — одно из поручений президента правительству и министерствам, опубликованных в начале июля этого года.
16 октября 2018
Фото: depositphotos.com
Выпуск: №177, октябрь 20181844 просмотров
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