Катрен Стиль
Минпромторг поменяет регламент проведения лицензионных проверок
Министерство промышленности и торговли разработало проект нового регламента, по которому будет проводиться лицензионный контроль производства лекарств. Проект документа был официально опубликован 19 сентября.
Административный регламент содержит подробное описание процедуры проведения проверок на соответствие производства ЛС лицензионным требованиям — последовательность действий, сроки выполнения и возможные результаты проверок. Кроме этого, в регламенте перечислены те требования к производителям препаратов, которые будут проверяться.
Документ вносит некоторые изменения в действующий регламент. Так, например, среди обязательных условий для производства фармацевтической субстанции этилового спирта появилось требование о том, что производственные линии должны быть оснащены средствами учета и контроля, а также оборудованием для передачи информации в систему ЕГАИС. Соответствующее постановление правительства было принято в июне этого года.
Также в новом регламенте перечислены все необходимые документы, которые Минпромторг вправе требовать у лицензиата (производителя) при проведении лицензионных проверок. Кроме того, документ впервые разрешает привлекать к участию в проверке уполномоченного по защите прав предпринимателей.
Напомним, что ранее Минпромторг опубликовал проект нового регламента, согласно которому будет проходить процедура лицензирования производства ЛС.
24 сентября 2018
Фото: depositphotos.com
Выпуск: №176, сентябрь 20182683 просмотров
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