Производитель «Лоперамида» отзывает серии ЛС, оставшиеся в обороте после отмены регистрации
17 мая 2021
Фото: depositphotos.com
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№208, май 2021
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Производитель «Лоперамида» отзывает серии ЛС, оставшиеся в обороте после отмены регистрации
Федеральная служба по надзору в сфере здравоохранения сообщает об отзыве из обращения трёх серий препарата «Лоперамид», регистрация которого была прекращена весной этого года. Информационное письмо об этом опубликовано 14 мая.
Речь идёт о сериях 10419, 20819 и 30819 лекарственного препарата «Лоперамид, таблетки, 2 мг 10 шт., упаковки ячейковые контурные (2), пачки картонные» производства ООО «ФАРМАКОР ПРОДАКШН» (Россия). Регистрация этого ЛС была отменена в апреле по обращению владельца регистрационного удостоверения.
Напомним, что реализация ЛС после отмены их государственной регистрации является административным нарушением и расценивается как «Продажа или ввоз на территорию Российской Федерации недоброкачественных лекарственных средств, либо реализация или ввоз недоброкачественных медицинских изделий, либо незаконные производство, продажа или ввоз незарегистрированных лекарственных средств» (ч. 2 статьи 6.33 КоАП РФ). Наказанием за это нарушение может служить крупный штраф в несколько сотен тысяч рублей.
Ранее компания ООО «Верваг Фарма» объявила об отзыве нескольких серий препарата «Метфогамма», которые также остались в обороте после прекращения регистрации.
«Катрен-Стиль» регулярно публикует обзоры информационных писем Росздравнадзора, посвящённых отзыву и изъятию ЛС, а также списки препаратов, лишившихся регистрации в течение месяца. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие таких ЛС. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
Катрен Стиль
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