Лицензирование производства ЛС переведут на «реестровую модель»
6 декабря 2020
Фото: depositphotos.com
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№203, декабрь 2020
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Лицензирование производства ЛС переведут на «реестровую модель»
Правительство России внесло изменения в Положение о лицензировании производства лекарственных средств. Со следующего года выдача лицензий на производство будет производиться по «реестровой модели». Соответствующее постановление от 02.12.2020 г. № 1986 опубликовано 4 декабря.
Реестровая модель предусматривает отказ от бумажных версий документов и замену их специальной базой данных (реестром), в которой хранится вся необходимая информация. Согласно постановлению, с 2021 года такой специальный реестр будет использоваться и для производителей лекарственных средств.
Вся информация о выданных или переоформленных лицензиях, а также сведения о их аннулировании, приостановлении, прекращении или возобновлении действия будут размещены в специальном регистре, доступном в интернете.
Вместо дубликатов или копий лицензий производители смогут получить выписку из реестра лицензий. Примечательно, что эта услуга останется платной. За выписку придётся заплатить пошлину, размер которой будет установлен «органом, определяющим государственную политику в сфере лицензирования».
Ранее на «реестровую модель» был переведён процесс выдачи лицензий на осуществление
фармацевтической деятельности.
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