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Вышла новая версия правил, по которым спиртосодержащие медизделия освободят от 171‑ФЗ
Вышла новая версия правил, по которым спиртосодержащие медизделия освободят от 171‑ФЗ
Минздрав опубликовал новую версию проекта правил, по которым отдельные спиртосодержащие медицинские изделия будут исключены из‑под действия закона 171‑ФЗ «О государственном регулировании производства и оборота этилового спирта». Документ доступен на портале проектов нормативных актов.
Напомним, что, согласно законодательству, правительство может создавать перечни медицинских изделий, содержащих фармацевтическую субстанцию этанол (этиловый спирт), на которые не распространяются положения закона 171‑ФЗ. В настоящий момент такого перечня не существует.
В связи с этим Минздрав в декабре прошлого года начал разработку правил составления подобного списка медизделий. В перечень будут включены изделия со следующими характеристиками:
- их нельзя использовать в качестве заменителя алкоголя из‑за объемов тары;
- цена на них на 20 % выше розничной стоимости алкогольной продукции;
- использование медизделия по инструкции не связано с употреблением внутрь.
Новая версия правил не меняет критериев по включению в перечень медицинских изделий, но вносит другие корректировки. Теперь в список предлагается включать конкретные наименования медизделий с указанием модели и номера регистрационного удостоверения, а не виды изделий, как это было в прошлой версии. Также все полномочия по формированию перечня и его дальнейшему контролю будут переданы от Минздрава к Росздравнадзору.
Общественное обсуждение проекта продлится до 11 марта. Согласно тексту документа, первый перечень спиртосодержащих медизделий, освобожденных от 171‑ФЗ, должен быть утвержден не позднее 15 декабря 2019 года.
20 февраля 2019
Фото: depositphotos.com
Выпуск: №181, февраль 20193612 просмотров
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