Катрен Стиль
В ЕАЭС предложили упростить маркировку орфанных препаратов
Коллегия Евразийской экономической комиссии подготовила проект изменений в Требования к маркировке лекарственных средств для медицинского применения и ветеринарных лекарственных средств, которые касаются маркировки ЛС, предназначенных для лечения редких заболеваний. Документ опубликован для общественного обсуждения 20 сентября.
Комиссия предлагает упростить маркировку орфанных и высокотехнологичных препаратов. Для таких ЛС можно будет использовать маркировку на русском языке без перевода на государственный язык страны Союза, на рынок которой поступит этот препарат. В исключительных случаях маркировка может быть только на английском языке.
Переведённая информация может быть дополнительно нанесена на вторичную упаковку в виде стикера.
Напомним, что в рамках общих требований, установленных в ЕЭАС, на упаковку ЛС должна наноситься маркировка на русском языке и на государственном языке государства — члена Союза, на территории которого препарат будет реализован. В ЕАЭС, помимо России, также входят Армения, Белоруссия, Казахстан и Киргизия.
Ранее Коллегией Евразийской экономической комиссии было подготовлено единое Руководство по фармацевтической разработке лекарственных средств для применения в педиатрической практике. Этим документом должны будут пользоваться производители ЛС из стран — участниц ЕАЭС при создании препаратов для детей.
21 сентября 2021
Фото: depositphotos.com
Выпуск: №213, сентябрь 2021834 просмотров
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