Катрен Стиль
Минздрав обратился к производителям ЛС без вторичной упаковки
Министерство здравоохранения 24 мая опубликовало информационное письмо для производителей лекарственных препаратов, получивших ранее разрешение на выпуск ЛС без вторичной упаковки. Ведомство рекомендует компаниям прекратить такую практику.
Минздрав напоминает, что согласно действующим положениям закона № 61‑ФЗ «Об обращении лекарственных средств» и Решения Совета Евразийской экономической комиссии от 03.11.2016 № 78 «О Правилах регистрации и экспертизы лекарственных средств для медицинского применения» отсутствие вторичной (потребительской) упаковки для лекарственных препаратов не предусмотрено.
В связи с этим всем производителям лекарственных препаратов, которые ранее получили разрешение на их реализацию без потребительской упаковки, необходимо предусмотреть внесение соответствующих изменений в регистрационные досье на такие ЛС с целью включения вторичной упаковки.
Министерство отмечает, что такой тип изменений можно сделать по российским правилам. В этом случае добавление вторичной упаковки будет отнесено к изменениям, не требующим проведения экспертизы качества или экспертизы отношения ожидаемой пользы к возможному риску применения лекарственного препарата.
25 мая 2023
Фото: © sanjagrujic (istockphoto.com)
Выпуск: №233, май 2023764 просмотров
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