Катрен Стиль
Для выдачи фармлицензии будут использоваться особые оценочные листы
Федеральная служба по надзору в сфере здравоохранения подготовила проект оценочных листов, по которым ведомство будет оценивать кандидатов для получения лицензии на фармацевтическую деятельность. Документ опубликован 21 декабря на портале нормативных актов.
Оценочный лист — это новый тип документа, введённый Федеральным законом от 11.06.2021 № 170‑ФЗ. По своей структуре он похож на проверочный лист, которые используется контролирующими органами при проведении проверок. Оценочный лист состоит из 50 вопросов, ответы на которые должны будут подтверждать соответствие заявителя требованиям для осуществления фармацевтической деятельности.
Такие листы будут использоваться Росздравнадзором для оценки не только желающих получить лицензию на фармацевтическую деятельность, но и тех, кто её уже имеет и хочет переоформить.
Для каждого вопроса указан нормативный документ, содержащий обязательные лицензионные требования. Большинство вопросов связаны с исполнением приказа от 31 августа 2016 г. № 646н «Об утверждении Правил надлежащей практики хранения и перевозки лекарственных препаратов для медицинского применения». В частности, о соответствии помещений, имеющихся у соискателя лицензии, условиям для хранения лекарственных средств. Например, о наличии отдельной карантинной зоны или об утверждённых стандартных операционных процедурах.
Ранее Роспотребнадзор подготовил проект приказа об утверждении проверочных листов, которые будут использованы при рейдовых осмотрах и выездных проверках помещений организаций.
22 декабря 2021
Фото: depositphotos.com
Выпуск: №216, декабрь 20212122 просмотров
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