Катрен Стиль
Опубликован проект нового проверочного листа для аптек (скачать)
Росздравнадзор представил проект нового проверочного листа (списка контрольных вопросов), который будет использоваться при проверке соблюдения лицензионных требований фармацевтической деятельности. Документ опубликован 10 марта на портале проектов нормативных актов.
Напомним, что сейчас Росздравнадзор использует проверочные листы при проведении плановых проверок по контролю безопасности медицинской деятельности, а также при проверках в сфере обращения лекарственных средств и медицинских изделий. Новый приказ позволит использовать проверочные листы при проверках выполнения обязательных требований, установленных законодательством к фармацевтической деятельности.
Вопросы в новом проверочном листе разделены на две части — для проверок оптовых поставщиков и организаций, занимающихся розничной торговлей. В аптеках будут проверять соблюдение обязательных требований, содержащихся в следующих нормативно-правовых актах:
- Правила надлежащей аптечной практики
- Правила надлежащей практики хранения и перевозки лекарственных препаратов
- Правила отпуска лекарственных препаратов, наркотических и психотропных средств, а также ЛС, содержащих такие вещества
- Правила регистрации операций, связанных с обращением ЛС, подлежащих предметно-количественному учету
- Правила ведения и хранения специальных журналов учета операций, связанных с обращением лекарственных препаратов
- Соблюдение установленных предельных размеров розничных надбавок к отпускным ценам ЖНВЛП
Также в списке контрольных вопросов будут пункты, касающиеся фармацевтического образования и сертификатов. Росздравнадзор будет проверять соответствие классификационным требованиям руководителей аптек, а также всех остальных сотрудников. Кроме этого, отдельным вопросом в документе указано наличие повышения квалификации специалистов с фармацевтическим образованием не реже 1 раза в 5 лет.
11 марта 2020
Фото: depositphotos.com
Выпуск: №194, март 202016110 просмотров
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