Росздравнадзор готовит новые штрафы для производителей за устаревшие инструкции
Наказывать производителей планируется за отсутствие в инструкции информации о выявленных побочных эффектах при применении препарата. Об этом заявил глава ведомства Михаил Мурашко на II съезде Союза «Национальная Фармацевтическая Палата» 19 апреля.
По словам Мурашко, на этапе регистрации препарата от производителя поступает только около 5 % информации, а остальное выясняется уже после выхода лекарства на рынок. Информационные письма о результатах новых клинических испытаний и требовании внесений изменения в инструкции публикуются на сайтах Минздрава и Росздравнадзора.
Однако производители не спешат этого делать. За первый квартал 2018 года Росздравнадзор выписал более 600 предупреждений для фармпроизводителей по поводу того, что они не вносят в инструкции данных о выявленных нежелательных реакциях.
В связи с этим ведомство планирует внести в Госдуму законопроект, который вводит ответственность для фармпроизводителей за несвоевременное внесение изменений в инструкции по применению. Это могут быть как денежные штрафы, так и приостановление оборота препарата и изъятие его с рынка.
Кроме этого Росздравнадзор планирует выпустить мобильное приложение для пациентов, в котором можно будет сообщать о побочных эффектах применяемых лекарств. Таким образом у ведомства появится дополнительный инструмент контроля безопасности лекарственных средств.
19 апреля 2018
Выпуск: №171, апрель 20182292 просмотров
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