Катрен Стиль
Минздрав назвал новые причины для внеплановых проверок аптек
Министерство здравоохранения утвердило новый перечень индикаторов риска нарушения обязательных требований при проверках в сфере обращения лекарственных средств. Соответствующий приказ от 07.12.2021 № 1130н опубликован 14 декабря.
Напомним, что «индикаторы риска» — это действия аптечных организаций, которые могут стать причинами для внеплановой проверки Росздравнадзора.
В новый перечень вошли два индикатора:
- Приобретение контролируемым лицом этилового спирта в объёме более 200 декалитров за прошедший календарный год.
- Наличие у контролируемого лица лекарственного препарата, в отношении которого по результатам мониторинга официальных интернет-сайтов зарубежных регуляторов получена информация о новых показателях качества такого ЛС, которая отсутствует в фармакопее или требованиях, установленных при его регистрации.
Примерами таких организаций могут служить FDA (Food and Drug Administration, Управление по надзору за качеством пищевых продуктов и медикаментов США), а также EMA (European Medicines Agency, Европейское агентство лекарственных средств).
Ранее индикатором риска, который мог привести к внеплановой проверке, был двукратный и более рост количества приобретённых и отпущенных лекарственных препаратов, подлежащих предметно-количественному учёту. Такие положения содержались в приказе № 893н, который утратил свою силу с утверждением нового перечня индикаторов.
В начале декабря Росздравнадзор подвёл итоги проверок аптек в 2021 году, назвав самые часто выявляемые нарушения.
15 декабря 2021
Фото: depositphotos.com
Выпуск: №216, декабрь 20212762 просмотров
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