За неверные данные в системе маркировки ЛС введут крупные штрафы
3 апреля 2019
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№183, апрель 2019
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За неверные данные в системе маркировки ЛС введут крупные штрафы
2 апреля Государственная дума приняла во втором чтении законопроект о введении штрафов за внесение неверных данных в информационную систему маркировки лекарств или за нарушение сроков подачи такой информации.
Документ предлагает ввести в Кодекс об административных правонарушениях новую статью: «Несвоевременное внесение данных в систему мониторинга движения лекарственных препаратов для медицинского применения либо внесение в нее недостоверных данных».
Штраф за такое нарушение составит от 5 до 10 тысяч рублей для должностных лиц и от 50 до 100 тысяч рублей — для юридических лиц. При этом индивидуальные предприниматели (осуществляющие предпринимательскую деятельность без образования юридического лица) будут приравниваться к юрлицам.
Кроме этого, законопроект дает Росздравнадзору право составлять протоколы об административных правонарушениях, касающихся обращения промаркированных препаратов. Минпромторг, в свою очередь, будет уполномочен составлять протоколы за нарушения требований маркировки при производстве лекарств.
Ранее глава Росздравнадзора Михаил Мурашко высказал предложение ввести штрафы за повторную продажу промаркированных препаратов.
Маркировка всех лекарственных препаратов станет обязательной с 1 января 2020 года. До этого момента аптекам необходимо подключиться к системе мониторинга движения лекарственных средств, иначе с нового года они не смогут полноценно отпускать препараты. Как это сделать — читайте в пошаговой инструкции от оператора системы «Маркировка».
Катрен Стиль
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