Минздрав представил новый порядок определения взаимозаменяемости ЛС
Ведомство разработало обновленный алгоритм определения взаимозаменяемости лекарственных препаратов, который придет на смену Постановлению Правительства от 28 октября 2015 г. № 1154. Проект новых правил опубликован 19 февраля на портале нормативных актов.
В конце прошлого года Государственная дума приняла поправки в Федеральный закон № 61‑ФЗ «Об обращении лекарственных средств», которые дали производителям возможность не доказывать биоэквивалентность уже зарегистрированных ЛС при определении взаимозаменяемости препаратов. Также поправки позволили автоматически признавать воспроизведенные и биоаналоговые препараты взаимозаменяемыми с референтными ЛС.
В связи с принятием этого закона требуется создание нового порядка признания лекарственных препаратов взаимозаменяемыми, который бы отразил все нововведения.
Проект новых правил устанавливает, что он будет действовать для определения взаимозаменяемости всех ЛС, зарегистрированных до 1 марта 2020 года, если их взаимозаменяемость не была определена по старым правилам.
Также до 1 июля 2020 года на сайте Минздрава должен быть опубликован перечень взаимозаменяемых препаратов, который будет регулярно обновляться по мере регистрации новых ЛС или внесения изменений в регистрационные документы.
Взаимозаменяемость препаратов будет определяться на основе заключения комиссии экспертов в рамках одного международного непатентованного (или химического, или группировочного) наименования. Исключением станут гомеопатические и растительные лекарственные препараты. На них правила определения взаимозаменяемости действовать не будут.
20 февраля 2020
Фото: depositphotos.com
Выпуск: №193, февраль 20202058 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 ) )
2058 просмотров
Поделиться ссылкой с друзьями ВКонтакте Одноклассники
Нашли ошибку? Выделите текст и нажмите Ctrl+Enter.
зарегистрированным пользователям