Катрен Стиль
В правила инспекции производителей лекарств внесут изменения
Министерство промышленности и торговли подготовило проект изменений в регламент проверок фармацевтических производителей на предмет соответствия требованиям правил надлежащей производственной практики. В частности, Минпромторг предлагает увеличить сроки, отведенные для выдачи (или отказа в выдаче) заключения о соответствии. Документ опубликован 15 апреля на портале проектов нормативных актов.
Поправки касаются Постановления Правительства от 03.12.15 № 1314 «Об определении соответствия производителей лекарственных средств требованиям правил надлежащей производственной практики».
Министерство предлагает увеличить срок, в который производитель должен получить заключение о соответствии требованиям (или отказ в его выдаче), с 10 рабочих дней до 30 календарных дней с момента завершения инспекции.
Кроме этого, причиной для отказа в проведении инспекции может стать отсутствие соглашения с иностранным производителем, где прописаны процедура инспектирования и связанные с ним расходы, права и обязанности инспекторов и самого производителя.
Также из порядка организации и проведения инспектирования будет исключен обязательный срок, в течение которого должна начаться проверка производителя. Сейчас он не должен превышать 160 рабочих дней со дня принятия уполномоченным органом решения о проведении инспектирования.
Последним изменением является введение планов корректирующих и предупреждающих действий (Corrective and preventive action, CAPA), если в ходе проверки были выявлены несоответствия требованиям. Такой документ, с описанием всех мероприятий по устранению замечаний и отчетом об их выполнении, иностранный производитель направляет в министерство. Минпромторг анализирует план и на его основе принимает решение о выдаче заключения о соответствии.
Ранее Правительство России утвердило изменения в государственную программу «Развитие фармацевтической и медицинской промышленности», продлив срок ее действия до 2024 года.
16 апреля 2019
Фото: depositphotos.com
Выпуск: №183, апрель 20191844 просмотров
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