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В России изменились лицензионные требования для производства спирта как фармсубстанции
В России изменились лицензионные требования для производства спирта как фармсубстанции
Правительство РФ ввело дополнительные требования для получения лицензии на производство этилового спирта в качестве фармацевтической субстанции. Соответствующее Постановление под номером 702 от 20.06.18 опубликовано 22 июня на Официальном портале правовой информации.
Теперь для производства этилового спирта (этанола) как фармсубстанции производственные линии должны быть оснащены автоматическими средствами измерения и учета, соответствующими требованиям Постановления № 396 от 28.06.06. Ранее они применялись для производства спирта, не являющегося фармацевтической субстанцией. Кроме этого, оборудование по производству должно быть оснащено средствами передачи информации в ЕГАИС об объеме производства и оборота этилового спирта. Такие требования вносятся в Положение о лицензировании производства лекарственных средств.
Также наличие систем учета и средств передачи информации в ЕГАИС становится обязательным лицензионным требованием, исполнение которого будет проверяться при проверках.
Это уже второе важное законодательное новшество для производителей ЛС за последние месяцы. Так, в мае этого года Государственная дума приняла закон, упростивший регистрацию лекарственных средств и разрешающий нескольким производителям использовать одну площадку для изготовления препаратов с одним МНН, но разными торговыми наименованиями.
26 июня 2018
Фото: www.istockphoto.com
Выпуск: №173, июнь 20183626 просмотров
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