С 29 ноября 2019 года вводится новый порядок ввода в гражданский оборот лекарственных препаратов для медицинского применения

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**Подробности**
**Категория: Прокуратура информирует**
**Опубликовано **30.12.2019 04:55****
**Автор: Администратор**
**Просмотров: 304**

С 29 ноября 2019 года вводится новый порядок ввода в гражданский оборот лекарственных препаратов для медицинского применения

 

Федеральный закон от 28.11.2018 № 449-ФЗ «О внесении изменений в отдельные законодательные акты Российской Федерации по вопросу ввода в гражданский оборот лекарственных препаратов для медицинского применения» устанавливается порядок:

представления документов и сведений о лекарственных препаратах, вводимых в гражданский оборот;

выдачи протокола испытаний о соответствии первых трех серий или партий лекарственного препарата (за исключением иммунобиологического), впервые произведенного в РФ или впервые ввозимого в РФ, показателям качества, предусмотренным нормативной документацией;

выдачи разрешения на ввод в гражданский оборот серии или партии иммунобиологического лекарственного препарата, выдачи заключения о соответствии серии или партии такого лекарственного препарата требованиям, установленным при его государственной регистрации;

принятия решения о прекращении гражданского оборота серии или партии лекарственного препарата.

В частности, производителям и импортерам лекарственных препаратов будет обеспечен авторизованный доступ посредством предоставления личного кабинета в АИС Росздравнадзора для представления ими необходимых документов и сведений о каждой серии или партии лекарственного препарата (за исключением иммунобиологического), вводимых в гражданский оборот.

Установлены размеры платы за выдачу протокола испытаний о соответствии первых трех серий или партий лекарственного препарата (за исключением иммунобиологического), впервые произведенного в РФ или впервые ввозимого в РФ, показателям качества, предусмотренным нормативной документацией, а также заключения о соответствии серии или партии иммунобиологического лекарственного препарата требованиям, установленным при его государственной регистрации.

Постановление вступило в силу с 29 ноября 2019 года.

 

Помощник прокурора Д.И. Панасюк

**Результаты профилирования**

Application 0.000 seconds (+0.000); 0.34 MB (+0.341) - afterLoad
Application 0.813 seconds (+0.812); 1.42 MB (+1.084) - afterInitialise
Application 1.588 seconds (+0.775); 7.01 MB (+5.583) - afterRoute
Application 2.195 seconds (+0.607); 8.05 MB (+1.044) - afterDispatch
Application 2.199 seconds (+0.005); 8.09 MB (+0.042) - afterRender

**Использование памяти**

8.11 MB (8,502,368 Bytes)

**30 SQL-запросов зафиксировано**

  1. SELECT `data`
      FROM `eiw83_session`
      WHERE `session_id` = 'c31ae6165d0c531321b718348cde0568'
  2. DELETE
      FROM `eiw83_session`
      WHERE `time` < 1749445917
  3. SELECT `session_id`
      FROM `eiw83_session`
      WHERE `session_id` = 'c31ae6165d0c531321b718348cde0568'
      LIMIT 0, 1
  4. INSERT INTO `eiw83_session` (`session_id`, `client_id`, `time`)
      VALUES ('c31ae6165d0c531321b718348cde0568', 0, 1749446817)
  5. SELECT extension_id AS "id", element AS "option", params, enabled
      FROM eiw83_extensions
      WHERE `type` = 'component'
      AND `element` = 'com_users'
  6. SELECT id, rules
      FROM `eiw83_viewlevels`
  7. SELECT folder AS type, element AS name, params
      FROM eiw83_extensions
      WHERE enabled >= 1
      AND type ='plugin'
      AND state >= 0
      AND access IN (1,1)
      ORDER BY ordering
  8. SELECT extension_id AS "id", element AS "option", params, enabled
      FROM eiw83_extensions
      WHERE `type` = 'component'
      AND `element` = 'com_languages'
  9. SELECT extension_id AS "id", element AS "option", params, enabled
      FROM eiw83_extensions
      WHERE `type` = 'component'
      AND `element` = 'com_kunena'
  10. select id, title, alias
      from eiw83_jumi
      where published = 1
  11. SELECT m.id, m.menutype, m.title, m.alias, m.path AS route, m.link, m.type, m.level, m.language,m.browserNav, m.access, m.params, m.home, m.img, m.template_style_id, m.component_id, m.parent_id,e.element as component
      FROM eiw83_menu AS m
      LEFT JOIN eiw83_extensions AS e
      ON m.component_id = e.extension_id
      WHERE m.published = 1
      AND m.parent_id > 0
      AND m.client_id = 0
      AND m.access IN (1,1)
      ORDER BY m.lft
  12. SELECT extension_id AS "id", element AS "option", params, enabled
      FROM eiw83_extensions
      WHERE `type` = 'component'
      AND `element` = 'com_content'
  13. SELECT c.*,CASE WHEN CHAR_LENGTH(c.alias) THEN CONCAT_WS(":", c.id, c.alias) ELSE c.id END as slug
      FROM eiw83_categories as c
      LEFT JOIN eiw83_categories AS s
      ON (s.lft <= c.lft
      AND s.rgt >= c.rgt) OR (s.lft > c.lft
      AND s.rgt < c.rgt)
      LEFT JOIN (SELECT cat.id as id
      FROM eiw83_categories AS cat JOIN eiw83_categories AS parent
      ON cat.lft BETWEEN parent.lft
      AND parent.rgt
      WHERE parent.extension = 'com_content'
      AND parent.published != 1
      GROUP BY cat.id) AS badcats
      ON badcats.id = c.id
      WHERE (c.extension='com_content' OR c.extension='system')
      AND c.access IN (1,1)
      AND c.published = 1
      AND s.id=7648
      AND badcats.id is null
      GROUP BY c.id
      ORDER BY c.lft
  14. SELECT alias, catid
      FROM eiw83_content
      WHERE id = 7648
  15. SELECT a.rules
      FROM eiw83_assets AS a
      WHERE a.id = 1
  16. SELECT b.rules
      FROM eiw83_assets AS a
      LEFT JOIN eiw83_assets AS b
      ON b.lft <= a.lft
      AND b.rgt >= a.rgt
      WHERE a.id = 1
      ORDER BY b.lft
  17. SELECT *
      FROM eiw83_jcomments_settings
  18. SELECT id, home, template, s.params
      FROM eiw83_template_styles as s
      LEFT JOIN eiw83_extensions as e
      ON e.element=s.template
      AND e.type='template'
      AND e.client_id=s.client_id
      WHERE s.client_id = 0
      AND e.enabled = 1
  19. SELECT *
      FROM eiw83_languages
      WHERE published=1
      ORDER BY ordering ASC
  20. SELECT b.rules
      FROM eiw83_assets AS a
      LEFT JOIN eiw83_assets AS b
      ON b.lft <= a.lft
      AND b.rgt >= a.rgt
      WHERE a.name = 'com_content'
      ORDER BY b.lft
  21. SELECT a.id, a.asset_id, a.title, a.alias, a.title_alias, a.introtext, a.fulltext, CASE WHEN badcats.id is null THEN a.state ELSE 0 END AS state, a.mask, a.catid, a.created, a.created_by, a.created_by_alias, a.modified, a.modified_by, a.checked_out, a.checked_out_time, a.publish_up, a.publish_down, a.images, a.urls, a.attribs, a.version, a.parentid, a.ordering, a.metakey, a.metadesc, a.access, a.hits, a.metadata, a.featured, a.language, a.xreference,c.title AS category_title, c.alias AS category_alias, c.access AS category_access,u.name AS author,contact.id as contactid,parent.title as parent_title, parent.id as parent_id, parent.path as parent_route, parent.alias as parent_alias,ROUND( v.rating_sum / v.rating_count ) AS rating, v.rating_count as rating_count
      FROM eiw83_content AS a
      LEFT JOIN eiw83_categories AS c
      on c.id = a.catid
      LEFT JOIN eiw83_users AS u
      on u.id = a.created_by
      LEFT JOIN eiw83_contact_details AS contact
      on contact.user_id = a.created_by
      LEFT JOIN eiw83_categories as parent
      ON parent.id = c.parent_id
      LEFT JOIN eiw83_content_rating AS v
      ON a.id = v.content_id
      LEFT
      OUTER JOIN (SELECT cat.id as id
      FROM eiw83_categories AS cat JOIN eiw83_categories AS parent
      ON cat.lft BETWEEN parent.lft
      AND parent.rgt
      WHERE parent.extension = 'com_content'
      AND parent.published <= 0
      GROUP BY cat.id) AS badcats
      ON badcats.id = c.id
      WHERE a.id = 7648
      AND (a.publish_up = '0000-00-00 00:00:00' OR a.publish_up <= '2025-06-09 05:26:58')
      AND (a.publish_down = '0000-00-00 00:00:00' OR a.publish_down >= '2025-06-09 05:26:58')
      AND (a.state = 1 OR a.state =2)
  22. SELECT c.*,CASE WHEN CHAR_LENGTH(c.alias) THEN CONCAT_WS(":", c.id, c.alias) ELSE c.id END as slug
      FROM eiw83_categories as c
      LEFT JOIN eiw83_categories AS s
      ON (s.lft <= c.lft
      AND s.rgt >= c.rgt) OR (s.lft > c.lft
      AND s.rgt < c.rgt)
      LEFT JOIN (SELECT cat.id as id
      FROM eiw83_categories AS cat JOIN eiw83_categories AS parent
      ON cat.lft BETWEEN parent.lft
      AND parent.rgt
      WHERE parent.extension = 'com_content'
      AND parent.published != 1
      GROUP BY cat.id) AS badcats
      ON badcats.id = c.id
      WHERE (c.extension='com_content' OR c.extension='system')
      AND c.access IN (1,1)
      AND c.published = 1
      AND s.id=107
      AND badcats.id is null
      GROUP BY c.id
      ORDER BY c.lft
  23. SHOW FULL COLUMNS
      FROM `eiw83_users`
  24. SELECT *
      FROM eiw83_users
      WHERE id = 42
  25. SELECT g.id, g.title
      FROM eiw83_usergroups AS g JOIN eiw83_user_usergroup_map AS m
      ON m.group_id = g.id
      WHERE m.user_id = 42
  26. SELECT b.id
      FROM eiw83_user_usergroup_map AS map
      LEFT JOIN eiw83_usergroups AS a
      ON a.id = map.group_id
      LEFT JOIN eiw83_usergroups AS b
      ON b.lft <= a.lft
      AND b.rgt >= a.rgt
      WHERE map.user_id = 42
  27. SELECT *
      FROM eiw83_fsj_plg_plugin
      WHERE type = 'include'
  28. SELECT *
      FROM eiw83_fsj_includes_alias
      WHERE state = 1
  29. UPDATE eiw83_content
      SET hits = hits + 1
      WHERE id = 7648
  30. UPDATE `eiw83_session`
      SET `data` = '__default|a:8:{s:15:\"session.counter\";i:1;s:19:\"session.timer.start\";i:1749446817;s:18:\"session.timer.last\";i:1749446817;s:17:\"session.timer.now\";i:1749446817;s:24:\"session.client.forwarded\";s:12:\"10.1.115.107\";s:22:\"session.client.browser\";s:103:\"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)\";s:8:\"registry\";O:9:\"JRegistry\":1:{s:7:\"\0*\0data\";O:8:\"stdClass\":0:{}}s:4:\"user\";O:5:\"JUser\":23:{s:9:\"\0*\0isRoot\";b:0;s:2:\"id\";i:0;s:4:\"name\";N;s:8:\"username\";N;s:5:\"email\";N;s:8:\"password\";N;s:14:\"password_clear\";s:0:\"\";s:8:\"usertype\";N;s:5:\"block\";N;s:9:\"sendEmail\";i:0;s:12:\"registerDate\";N;s:13:\"lastvisitDate\";N;s:10:\"activation\";N;s:6:\"params\";N;s:6:\"groups\";a:0:{}s:5:\"guest\";i:1;s:10:\"\0*\0_params\";O:9:\"JRegistry\":1:{s:7:\"\0*\0data\";O:8:\"stdClass\":0:{}}s:14:\"\0*\0_authGroups\";a:1:{i:0;s:1:\"1\";}s:14:\"\0*\0_authLevels\";a:2:{i:0;i:1;i:1;i:1;}s:15:\"\0*\0_authActions\";N;s:12:\"\0*\0_errorMsg\";N;s:10:\"\0*\0_errors\";a:0:{}s:3:\"aid\";i:0;}}', `time` = 1749446818
      WHERE `session_id` = 'c31ae6165d0c531321b718348cde0568'

**25 типов SQL-запросов зафиксировано, отсортировано по вхождениям**

**Запросы типа SELECT:**
  1. **4 × SELECT extension_id AS "id", element AS "option", params, enabled FROM eiw83_extensions**
  2. **2 × SELECT b.rules FROM eiw83_assets AS a LEFT JOIN eiw83_assets AS b ON b.lft <= a.lft AND b.rgt >= a.rgt**
  3. **2 × SELECT c.*,CASE WHEN CHAR_LENGTH(c.alias) THEN CONCAT_WS(":", c.id, c.alias) ELSE c.id END as slug FROM eiw83_categories as c LEFT JOIN eiw83_categories AS s ON (s.lft <= c.lft AND s.rgt >= c.rgt) OR (s.lft > c.lft AND s.rgt < c.rgt) LEFT JOIN (SELECT cat.id as id FROM eiw83_categories AS cat JOIN eiw83_categories AS parent ON cat.lft BETWEEN parent.lft AND parent.rgt**
  4. **1 × SELECT a.id, a.asset_id, a.title, a.alias, a.title_alias, a.introtext, a.fulltext, CASE WHEN badcats.id is null THEN a.state ELSE 0 END AS state, a.mask, a.catid, a.created, a.created_by, a.created_by_alias, a.modified, a.modified_by, a.checked_out, a.checked_out_time, a.publish_up, a.publish_down, a.images, a.urls, a.attribs, a.version, a.parentid, a.ordering, a.metakey, a.metadesc, a.access, a.hits, a.metadata, a.featured, a.language, a.xreference,c.title AS category_title, c.alias AS category_alias, c.access AS category_access,u.name AS author,contact.id as contactid,parent.title as parent_title, parent.id as parent_id, parent.path as parent_route, parent.alias as parent_alias,ROUND( v.rating_sum / v.rating_count ) AS rating, v.rating_count as rating_count FROM eiw83_content AS a LEFT JOIN eiw83_categories AS c on c.id = a.catid LEFT JOIN eiw83_users AS u on u.id = a.created_by LEFT JOIN eiw83_contact_details AS contact on contact.user_id = a.created_by LEFT JOIN eiw83_categories as parent ON parent.id = c.parent_id LEFT JOIN eiw83_content_rating AS v ON a.id = v.content_id LEFT OUTER JOIN (SELECT cat.id as id FROM eiw83_categories AS cat JOIN eiw83_categories AS parent ON cat.lft BETWEEN parent.lft AND parent.rgt**
  5. **1 × SELECT * FROM eiw83_languages**
  6. **1 × SELECT * FROM eiw83_users**
  7. **1 × SELECT g.id, g.title FROM eiw83_usergroups AS g JOIN eiw83_user_usergroup_map AS m ON m.group_id = g.id**
  8. **1 × SELECT * FROM eiw83_fsj_includes_alias**
  9. **1 × SELECT * FROM eiw83_fsj_plg_plugin**
  10. **1 × SELECT b.id FROM eiw83_user_usergroup_map AS map LEFT JOIN eiw83_usergroups AS a ON a.id = map.group_id LEFT JOIN eiw83_usergroups AS b ON b.lft <= a.lft AND b.rgt >= a.rgt**
  11. **1 × SELECT id, home, template, s.params FROM eiw83_template_styles as s LEFT JOIN eiw83_extensions as e ON e.element=s.template AND e.type='template' AND e.client_id=s.client_id**
  12. **1 × SELECT a.rules FROM eiw83_assets AS a**
  13. **1 × SELECT folder AS type, element AS name, params FROM eiw83_extensions**
  14. **1 × SELECT id, rules FROM `eiw83_viewlevels**
  15. **1 × SELECT `session_id` FROM `eiw83_session`**
  16. **1 × select id, title, alias from eiw83_jumi**
  17. **1 × SELECT m.id, m.menutype, m.title, m.alias, m.path AS route, m.link, m.type, m.level, m.language,m.browserNav, m.access, m.params, m.home, m.img, m.template_style_id, m.component_id, m.parent_id,e.element as component FROM eiw83_menu AS m LEFT JOIN eiw83_extensions AS e ON m.component_id = e.extension_id**
  18. **1 × SELECT `data` FROM `eiw83_session`**
  19. **1 × SELECT alias, catid FROM eiw83_content**
  20. **1 × SELECT * FROM eiw83_jcomments_setting**
**Прочие SQL-запросы:**
  1. **1 × UPDATE `eiw83_session` SET `data` = '__default|a:8:{s:15:\"session.counter\";i:1;s:19:\"session.timer.start\";i:1749446817;s:18:\"session.timer.last\";i:1749446817;s:17:\"session.timer.now\";i:1749446817;s:24:\"session.client.forwarded\";s:12:\"10.1.115.107\";s:22:\"session.client.browser\";s:103:\"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)\";s:8:\"registry\";O:9:\"JRegistry\":1:{s:7:\"\0*\0data\";O:8:\"stdClass\":0:{}}s:4:\"user\";O:5:\"JUser\":23:{s:9:\"\0*\0isRoot\";b:0;s:2:\"id\";i:0;s:4:\"name\";N;s:8:\"username\";N;s:5:\"email\";N;s:8:\"password\";N;s:14:\"password_clear\";s:0:\"\";s:8:\"usertype\";N;s:5:\"block\";N;s:9:\"sendEmail\";i:0;s:12:\"registerDate\";N;s:13:\"lastvisitDate\";N;s:10:\"activation\";N;s:6:\"params\";N;s:6:\"groups\";a:0:{}s:5:\"guest\";i:1;s:10:\"\0*\0_params\";O:9:\"JRegistry\":1:{s:7:\"\0*\0data\";O:8:\"stdClass\":0:{}}s:14:\"\0*\0_authGroups\";a:1:{i:0;s:1:\"1\";}s:14:\"\0*\0_authLevels\";a:2:{i:0;i:1;i:1;i:1;}s:15:\"\0*\0_authActions\";N;s:12:\"\0*\0_errorMsg\";N;s:10:\"\0*\0_errors\";a:0:{}s:3:\"aid\";i:0;}}', `time` = 1749446818**
  2. **1 × UPDATE eiw83_content SET hits = hits + 1**
  3. **1 × SHOW FULL COLUMNS FROM `eiw83_users**
  4. **1 × INSERT INTO `eiw83_session` (`session_id`, `client_id`, `time`) VALUES ('c31ae6165d0c531321b718348cde0568', 0, 1749446817**
  5. **1 × DELETE FROM `eiw83_session`**

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