Катрен Стиль
Утверждены оценочные листы для получения фармацевтической лицензии
Федеральная служба по надзору в сфере здравоохранения официально утвердила формы оценочных листов, по которым ведомство будет проводить оценку соответствия соискателя на получение лицензии на осуществление фармацевтической деятельности. Соответствующий приказ от 19.01.2022 № 195 опубликован 25 февраля.
Напомним, что оценочные листы близки по своей сути к «проверочным листам», которые Росздравнадзор использует при проведении контрольных мероприятий. Это списки вопросов, подразумевающих ответ «да» или «нет», которые позволяют проверить организацию (или ИП) на соответствие требованиям для получения фармлицензии.
Итоговый приказ не отличается от проекта, представленного в декабре прошлого года. Документ состоит из двух форм листов — для получения лицензии на оптовую торговлю ЛС и для розничных аптек. Для оптовиков предусмотрено 49 вопросов, для аптек — 46. Вопросы касаются наличия необходимых помещений, утверждённых СОПов и соблюдения требований Надлежащих практик. Для каждого вопроса указан пункт нормативного акта, требования которого он оценивает.
Оценочные листы будут использоваться Росздравнадзором не только для выдачи новых лицензий, но и при переоформлении уже действующих.
Полный разбор оценочных листов и предположение о том, как они будут применяться на практике, читайте в нашей статье «Листы для лицензирования».
28 февраля 2022
Фото: depositphotos.com
Выпуск: №219, март 20221558 просмотров
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