Катрен Стиль21 апреля 2022
Фото: © Irina1_Nikolaenko/Фотобанк Фотодженика
Выпуск: №220, апрель 2022373 просмотров
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В России могут упростить регистрацию ветеринарных ЛС
Депутаты Государственной думы в первом чтении приняли поправки в законодательство, которые позволят существенно сократить срок регистрации лекарственных препаратов, предназначенных для лечения животных. Информация об этом опубликована на сайте Думы 20 апреля.
Сейчас, согласно закону «Об обращении лекарственных средств» ускоренную процедуру регистрации можно применять к орфанным ЛС, первым дженерикам и лекарственными препаратам, предназначенным для применения исключительно несовершеннолетними пациентами. Для таких ЛС максимальный срок с момента подачи заявления до выдачи регистрационного удостоверения не может превышать 80 дней.
Законопроект предлагает расширить этот перечень, добавив в него ветеринарные препараты, если их действующее вещество уже зарегистрировано в качестве лекарственного средства для медицинского применения.
В таком случае, вместо отчета о результатах доклинического исследования можно будет предоставлять результаты доклинического исследования соответствующего ЛС для медицинского применения, а вместо отчета о клинических исследованиях — обзор научных данных о результатах испытаний на видах животных, которым предназначается исследуемый лекарственный препарат.
Ранее депутаты Госдумы также утвердили законопроект, который допускает применять «упрощённую схему» регистрации для ЛС, которые рискуют уйти с рынка в связи с введением в отношении Российской Федерации ограничительных мер экономического характера.
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