Минздрав представил порядок усиления контроля за качеством ЛС
4 апреля 2019
Фото: depositphotos.com
Выпуск:
№183, апрель 2019
2191 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
)
)
Минздрав представил порядок усиления контроля за качеством ЛС
Ведомство опубликовало проект постановления, в котором перечислены документы, которые производители должны предоставлять в Росздравнадзор перед вводом в оборот каждой серии лекарственного препарата. Документ опубликован 4 апреля на портале проектов нормативных актов.
Согласно принятому Госдумой в прошлом году закону, фармкомпании перед вводом в оборот серии или партии ЛС обязаны предоставить в Росздравнадзор документ, подтверждающий качество лекарственного препарата и его соответствие требованиям, установленным при регистрации. В настоящий момент требований к таким документам и к тому, как они должны подаваться, нет, поскольку исполнение закона станет обязательным только с 29 ноября 2019 года.
Именно для этого Минздрав и разработал проект порядка представления документов и сведений о ЛС, вводимых в гражданский оборот. Данные будут вноситься в автоматическую информационную систему Росздравнадзора. Для ввода серии в обращение необходимо будет предоставить сведения о препарате, а также документ, подтверждающий соответствие требованиям нормативной документации и регистрационным требованиям.
Если на рынок поступает впервые произведенный препарат (или впервые ввезенный в Россию), то для первых трех серий необходимо дополнительно предоставить протоколы клинических испытаний, проведенных в аккредитованных Минздравом организациях.
В качестве дополнительной меры контроля за соблюдением этих требований министерство разработало проект постановления, которое разрешит Росздравнадзору отзывать из обращения серии лекарств, для которых не были поданы необходимые документы.
Напомним, что ранее Минздрав утвердил новый порядок приостановления применения ЛС в России, расширяющий список причин, по которым тот или иной препарат может быть изъят из оборота.
Катрен Стиль
зарегистрированным пользователям