Катрен Стиль
Отменена регистрация импортной разогревающей мази
Министерство здравоохранения сообщает об отмене государственной регистрации и исключении из реестра местнораздражающей мази «Никофлекс». Приказ об этом опубликован 11 июня в Государственном реестре лекарственных средств.
Речь идет о мази для наружного применения «Никофлекс» (МНН отсутствует) производства ЗАО «Реанал» (Венгрия), регистрационное удостоверение П № 011978/11 от 14.09.2012, выдано ЗАО «Медимпэкс». Решение об отмене регистрации принято на основании подачи заявления от ООО «ЭГИС-РУС» — уполномоченного представителя держателя 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 служит крупный штраф: для должностных лиц — от ста тысяч до шестисот тысяч рублей; для индивидуальных предпринимателей — от ста тысяч до шестисот тысяч рублей или административное приостановление деятельности на срок до девяноста суток, а для юридических лиц — от одного миллиона до пяти миллионов рублей или административное приостановление деятельности на срок до девяноста суток.
Ранее была отменена государственная регистрация импортного интерферона «Реальдирон».
«Катрен-Стиль» ежемесячно публикует обзоры информационных писем Росздравнадзора, посвященных отзыву и изъятию ЛС, а также последним изменениям в ГРЛС. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие «карантинных» или лишившихся регистрации препаратов. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
15 июня 2020
Фото: depositphotos.com
Выпуск: №197, июнь 20208213 просмотров
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