Катрен Стиль
Росздравнадзор анонсировал изменения в проверочных листах
Ведомство опубликовало проект приказа о внесении изменений в приказ о проверочных листах, используемых при плановых проверках оборота медицинских изделий (приказ № 10449 от 20.12.17). Росздравнадзор планирует убрать несколько вопросов, касающихся маркировки медизделий на русском языке. Проект приказа опубликован 6 июля на портале проектов нормативных актов.
Необходимость изменений обоснована тем, что в разделах проверочных листов, посвященных обязательной маркировке на русском языке, указана ссылка на Постановление Правительства № 1037 от 15.08.97. Это Постановление утратило силу в марте 2018 года, из‑за чего проверка соблюдения этих требований при контрольных мероприятиях попросту невозможна.
Таким образом, Росздравнадзор планирует полностью исключить все упоминания Постановления № 1037 из проверочных листов, а также убрать связанные с ним обязательные вопросы. Это пункты 6.1 и 6.2 из Приложения № 4 приказа о проверочных листах (форма проверочного листа для проверок производителей).
Речь идет о вопросах:
«Имеется ли маркировка медицинских изделий на русском языке?»
«Имеется ли инструкция по применению медицинских изделий на русском языке?»
Вопросы с 1 по 5 включительно из Приложения № 7, связанные с маркировкой на русском языке (формы проверочных листов при проверках хранения и реализации медизделий).
Напомним, что отмена Постановления № 1037 не означает отсутствия требований маркировки на русском языке при обращении медицинских изделий. В настоящий момент требования к маркировке установлены решением Совета Евразийской экономической комиссии № 27 от 12.02.16.
9 июля 2018
Фото: www.istockphoto.com
Выпуск: №174, июль 20183513 просмотров
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