Аптеку оштрафовали на полмиллиона за продажу препарата с фенспиридом
Территориальный орган Росздравнадзора по Ростовской области добился крупного штрафа для аптеки за реализацию лекарственного препарата «Эреспал», регистрация которого была прекращена в марте 2019 года. Сообщение об этом опубликовано на официальном сайте ростовского отделения ведомства.
Территориальный орган Росздравнадзора по Ростовской области выявил факты продажи препарата «Эреспал» после прекращения его регистрации. За такое правонарушение арбитражный суд постановил привлечь аптеку к административной ответственности по ч. 2 ст. 6.33 КоАПП «Продажа или ввоз на территорию РФ незарегистрированных лекарственных средств». Сумма штрафа составила 500 тысяч рублей. Отметим, что максимальный штраф за такое нарушение для юридических лиц — 5 миллионов рублей.
Напомним, что в феврале этого года компания «Сервье», производитель «Эреспала», приняла решение отозвать с рынка все серии препарата и отозвать регистрационные удостоверения из‑за возможного побочного действия фенспирида — действующего вещества препарата. Окончательно «Эреспал» был исключен из реестра 22 марта.
Кроме «Эреспала», в феврале с рынка были отозваны и другие препараты с фенспиридом: «Эпистат» и «Эриспирус». При этом производитель «Эриспируса» компания «Сандоз» также приняла решение аннулировать регистрацию препарата.
Ранее комитет Европейского агентства по лекарственным средствам (EMA) принял решение запретить продажу препаратов с фенспиридом во всех европейских странах.
23 мая 2019
Фото: depositphotos.com
Выпуск: №184, май 20194012 просмотров
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