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.
21 апреля 2022
Фото: © Irina1_Nikolaenko/Фотобанк Фотодженика
Выпуск: №220, апрель 2022487 просмотров
Array ( [0] => Array ( [ID] => 16466 [~ID] => 16466 [NAME] => apteka.ru/search/?q=%D1%81%D1%82%D0%B5%D0%BB%D0%BB%D0%B0%D0%BD%D0%B8%D0%BD&order=products%2Cmaterials&vendor= [~NAME] => apteka.ru/search/?q=%D1%81%D1%82%D0%B5%D0%BB%D0%BB%D0%B0%D0%BD%D0%B8%D0%BD&order=products%2Cmaterials&vendor= [DATE_ACTIVE_FROM] => 01.09.2019 11:17:00 [~DATE_ACTIVE_FROM] => 01.09.2019 11:17:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 8171 [~PREVIEW_PICTURE] => 8171 ) [PROPERTIES] => Array ( [SWF] => Array ( [ID] => 99 [TIMESTAMP_X] => 2018-08-19 19:34:17 [IBLOCK_ID] => 12 [NAME] => Ссылка во флеше (link1) [ACTIVE] => Y [SORT] => 500 [CODE] => SWF [DEFAULT_VALUE] => [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 50 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Ссылка во флеше (link1) [~DEFAULT_VALUE] => ) [LINK] => Array ( [ID] => 100 [TIMESTAMP_X] => 2018-08-19 19:34:17 [IBLOCK_ID] => 12 [NAME] => Ссылка (без протокола) [ACTIVE] => Y [SORT] => 500 [CODE] => LINK [DEFAULT_VALUE] => [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 50 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => 320465417 [VALUE] => apteka.ru/search/?q=%D0%B1%D0%B5%D1%80%D0%B5%D1%88&order=products%2Cmaterials&vendor=0 [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => apteka.ru/search/?q=%D0%B1%D0%B5%D1%80%D0%B5%D1%88&order=products%2Cmaterials&vendor=0 [~DESCRIPTION] => [~NAME] => Ссылка (без протокола) [~DEFAULT_VALUE] => ) [WEBINARS] => Array ( [ID] => 102 [TIMESTAMP_X] => 2020-11-05 08:23:57 [IBLOCK_ID] => 12 [NAME] => Вебинары [ACTIVE] => Y [SORT] => 500 [CODE] => WEBINARS [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 5 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => Y [multiple] => Y ) [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Вебинары [~DEFAULT_VALUE] => ) [TYPES] => Array ( [ID] => 103 [TIMESTAMP_X] => 2018-08-20 03:08:52 [IBLOCK_ID] => 12 [NAME] => Где показывать [ACTIVE] => Y [SORT] => 500 [CODE] => TYPES [DEFAULT_VALUE] => [PROPERTY_TYPE] => L [ROW_COUNT] => 20 [COL_COUNT] => 30 [LIST_TYPE] => C [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => Array ( [0] => 320482201 ) [VALUE] => Array ( [0] => Страница статьи (273px) ) [DESCRIPTION] => Array ( [0] => ) [VALUE_ENUM] => Array ( [0] => Страница статьи (273px) ) [VALUE_XML_ID] => Array ( [0] => ade3837e8e0b9a67adab1fec2bc57639 ) [VALUE_SORT] => Array ( [0] => 500 ) [VALUE_ENUM_ID] => Array ( [0] => 458 ) [~VALUE] => Array ( [0] => Страница статьи (273px) ) [~DESCRIPTION] => Array ( [0] => ) [~NAME] => Где показывать [~DEFAULT_VALUE] => ) [RUBRICS] => Array ( [ID] => 104 [TIMESTAMP_X] => 2018-08-20 03:09:12 [IBLOCK_ID] => 12 [NAME] => Рубрики [ACTIVE] => Y [SORT] => 500 [CODE] => RUBRICS [DEFAULT_VALUE] => [PROPERTY_TYPE] => G [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 20 [TMP_ID] => [LINK_IBLOCK_ID] => 2 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Рубрики [~DEFAULT_VALUE] => ) [VIEWS] => Array ( [ID] => 105 [TIMESTAMP_X] => 2018-08-19 23:38:24 [IBLOCK_ID] => 12 [NAME] => Показы [ACTIVE] => Y [SORT] => 500 [CODE] => VIEWS [DEFAULT_VALUE] => [PROPERTY_TYPE] => N [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Показы [~DEFAULT_VALUE] => ) [CLICKS] => Array ( [ID] => 106 [TIMESTAMP_X] => 2018-08-19 23:38:24 [IBLOCK_ID] => 12 [NAME] => Клики [ACTIVE] => Y [SORT] => 500 [CODE] => CLICKS [DEFAULT_VALUE] => [PROPERTY_TYPE] => N [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Клики [~DEFAULT_VALUE] => ) [ARTICLE] => Array ( [ID] => 116 [TIMESTAMP_X] => 2019-05-17 13:18:54 [IBLOCK_ID] => 12 [NAME] => Статьи [ACTIVE] => Y [SORT] => 500 [CODE] => ARTICLE [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 2 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => N [multiple] => Y ) [HINT] => [PROPERTY_VALUE_ID] => Array ( [0] => 320482202 ) [VALUE] => Array ( [0] => 32724 ) [DESCRIPTION] => Array ( [0] => ) [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [0] => 32724 ) [~DESCRIPTION] => Array ( [0] => ) [~NAME] => Статьи [~DEFAULT_VALUE] => ) [CRIB] => Array ( [ID] => 117 [TIMESTAMP_X] => 2019-05-30 07:53:16 [IBLOCK_ID] => 12 [NAME] => Шпаргалки [ACTIVE] => Y [SORT] => 500 [CODE] => CRIB [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 3 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => N [multiple] => N ) [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Шпаргалки [~DEFAULT_VALUE] => ) ) [1] => Array ( [ID] => 15705 [~ID] => 15705 [NAME] => Стелланин апрель [~NAME] => Стелланин апрель [DATE_ACTIVE_FROM] => 01.04.2019 13:37:00 [~DATE_ACTIVE_FROM] => 01.04.2019 13:37:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 7449 [~PREVIEW_PICTURE] => 7449 ) [2] => Array ( [ID] => 32741 [~ID] => 32741 [NAME] => Береш Май Обзор писем РЗН [~NAME] => Береш Май Обзор писем РЗН [DATE_ACTIVE_FROM] => 28.05.2020 08:53:00 [~DATE_ACTIVE_FROM] => 28.05.2020 08:53:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 10191 [~PREVIEW_PICTURE] => 10191 ) )
487 просмотров
Поделиться ссылкой с друзьями ВКонтакте Одноклассники
Нашли ошибку? Выделите текст и нажмите Ctrl+Enter.
зарегистрированным пользователям