Катрен Стиль
Изменен порядок выдачи разрешения на проведение клинических исследований ЛС
Министерство здравоохранения внесло изменения в процедуру получения разрешения на проведение клинических исследований лекарственных препаратов, а также в порядок аккредитации медицинских организаций на право проведения таких исследований. Соответствующий приказ № 880н от 24.10.2019 официально опубликован 25 февраля на портале правовой информации.
Новый приказ вносит поправки в регламент Минздрава по предоставлению государственной услуги по выдаче разрешения на проведение клинического исследования лекарственного препарата, утвержденный приказом от 19 января 2018 г. № 20н. Также правки коснулись приказа от 13 февраля 2018 г. № 67н, утвердившего Административный регламент Минздрава по аккредитации медицинских организаций на право проведения клинических исследований.
Теперь вся необходимая справочная информация (график работы министерства, справочные телефоны структурных подразделений) будет размещена на официальном сайте Минздрава, на Едином портале «Госуслуги» и в информационной системе «Федеральный реестр государственных и муниципальных функций».
Также приостановление услуги по разрешению проведения испытаний, вызванное неправильно оформленными документами или уточнением необходимой информации, теперь не может превышать 90 дней. Ранее разрешение могло быть приостановлено на срок 106 рабочих дней.
Кроме этого, в регламент внесены поправки, касающиеся досудебного обжалования решений или действий Минздрава. Теперь вся информация, касающаяся подачи жалобы и хода ее рассмотрения, должна быть размещена на Едином портале госуслуг, даже если сама жалоба не была подана в электронной форме.
Ранее Правительство России составило план по переходу министерств и ведомств на оформление разрешительных документов в электронном виде. Так, к 2021 году через портал «Госуслуги» можно будет получить выписку о прохождении аккредитации.
26 февраля 2020
Фото: depositphotos.com
Выпуск: №193, февраль 20201720 просмотров
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