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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: Illegal string offset 'exts' in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 402

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Warning: in_array() expects parameter 2 to be array, string given in /var/data/web/RTi/medialaw/www/wp-content/plugins/attachment-manager/wp-attachment-manager.php on line 403

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Право и СМИ Центральной Азии

В Казахстане утверждены правила выдачи разрешения на рекламу лекарств

В Казахстане утверждены правила выдачи разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники (Приказ Министра здравоохранения Республики Казахстан от 20 марта 2013 года № 167 «Об утверждении Правил выдачи разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники в Республике Казахстан»), сообщает Zakon.kz.

Правила разработаны в соответствии с пунктом 1 статьи 18 Кодекса Республики Казахстан от 18 сентября 2009 года «О здоровье народа и системе здравоохранения» и определяют порядок выдачи разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники в Республике Казахстан с использованием Государственной базы данных «Е-лицензирование» (ГБД ЕЛ).

Выдачу разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники осуществляет Государственное учреждение «Департамент Комитета контроля медицинской и фармацевтической деятельности по городу Алматы».

Обязательным условием выдачи разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники является проведение предварительной экспертизы рекламного материала в государственной экспертной организации в сфере обращения лекарственных средств, изделий медицинского назначения и медицинской техники.

Разрешение на рекламу выдается на срок действия регистрационного удостоверения лекарственных средств, изделий медицинского назначения и медицинской техники по форме согласно приложению 2 к Стандарту государственной услуги «Выдача разрешения на рекламу лекарственных средств, изделий медицинского назначения и медицинской техники», утвержденному постановлением Правительства Республики Казахстан от 8 октября 2012 года № 1262 (далее — Стандарт).

Рекламируемые свойства и характеристики лекарственных средств, изделий медицинского назначения и медицинской техники независимо от вида рекламы должны соответствовать инструкции по медицинскому применению, утвержденной уполномоченным органом при государственной регистрации, эксплуатационному документу для медицинской техники.

Лекарственные средства, изделия медицинского назначения и медицинская техника, распространяемые в качестве рекламных образцов, должны быть зарегистрированы в Республике Казахстан и сопровождаться инструкцией по медицинскому применению, эксплуатационным документом (для медицинской техники).

Правила не распространяются на ниже перечисленное при условии, что в них не содержится ссылок и рекламных утверждений о лекарственном средстве, изделий медицинского назначения и медицинской технике:

1) информацию, имеющую отношение к здоровью или заболеваниям человека;

2) инструкцию по медицинскому применению, торговые каталоги, прайс-листы, справочные материалы, научно-информационный материал, методические и учебные материалы медицинского характера;

3) информацию о физическом или юридическом лице, производящем или реализующем лекарственное средство, изделие медицинского назначения и медицинскую технику;

4) нанесение логотипа, торгового и/или международного непатентованного названия на промышленную продукцию, распространяемую среди медицинских и фармацевтических работников (ручки, блокноты, сумки, медицинские халаты и другое).

Реклама лекарственных препаратов, отпускаемых по рецепту, а также лекарственных препаратов, содержащих наркотические средства, психотропные вещества, прекурсоры и находящиеся под контролем в соответствии с законодательством Республики Казахстан предназначена для медицинских и фармацевтических работников (специалистов) и может осуществляться только в специализированных печатных изданиях, предназначенных для медицинских и фармацевтических работников.

Реклама лекарственных препаратов, отпускаемых без рецепта, изделий медицинского назначения и медицинской техники может осуществляться в средствах массовой информации и в организациях здравоохранения и предназначена для населения.

Реклама лекарственных средств, изделий медицинского назначения и медицинской техники и используемый в ней рекламный слоган:

1) представляется на государственном и русском языках легко читаемым, четким и разборчивым шрифтом;

2) исполняется в таком виде, чтобы было ясно, что рекламируемое средство является лекарственным средством, изделием медицинского назначения, медицинской техникой;

3) способствует рациональному применению лекарственных средств, изделий медицинского назначения и медицинской техники;

4) не преувеличивает фармакологические свойства и терапевтические показания рекламируемого лекарственного средства, область применения для изделий медицинского назначения и медицинской техники;

5) содержит информацию о государственной регистрации в Республике Казахстан (дату выдачи, номер регистрационного удостоверения);

6) содержит информацию о разрешении на рекламу (дату выдачи, номер, срок окончания действия разрешения на рекламу).

До подачи заявления на выдачу разрешения на рекламу заявитель представляет в экспертную организацию рекламные материалы (модуль, аудио- видео, статья) для предварительной экспертизы лекарственного средства, изделия медицинского назначения и медицинской техники.

Реклама для населения излагается на доступном языке, распознается без специальных знаний или применения специальных средств и показывает, что рекламируемое средство является лекарственным средством, изделием медицинского назначения или медицинской техникой.

Реклама лекарственных препаратов содержит информацию, необходимую для их правильного и рационального применения:

1) торговое наименование;

2) международное непатентованное название или состав;

3) основные показания к применению;

4) способ применения и дозы;

5) основные побочные действия;

6) основные противопоказания;

7) особые указания в отношении детей, беременных женщин, а также в период кормления грудью;

8) условия отпуска;

9) ясную и наглядную рекомендацию перед назначением и применением внимательно прочитать инструкцию по медицинскому применению;

10) название, адрес производителя и/или торгового представителя в Республике Казахстан.

В рекламе лекарственных препаратов, отпускаемых по рецепту, дополнительно указываются основные лекарственные взаимодействия.

Реклама изделий медицинского назначения и медицинской техники содержит:

1) торговое наименование;

2) основные показания к применению;

3) способ применения;

4) основные побочные действия при наличии;

5) основные противопоказания при наличии;

6) ясную и наглядную рекомендацию перед назначением и применением внимательно прочитать инструкцию по медицинскому применению (эксплуатационный документ для медицинской техники);

7) название, адрес производителя и/или торгового представителя в Республике Казахстан.

В рекламе лекарственных средств, изделий медицинского назначения и медицинской техники для населения не допускается использовать информацию в которой:

1) присутствует описание симптомов заболевания или приводятся истории болезни, которые могут привести к ошибочной диагностике и самодиагностике;

2) создается впечатление отсутствия необходимости медицинских консультаций или хирургических операций;

3) используются изображения изменений в человеческом организме или частей тела до и после применения;

4) внушается, что здоровье человека может быть ухудшено неприменением (не использованием) рекламируемой продукции;

5) присутствуют ссылки на отзывы о выздоровлении.

Контроль за исполнением приказа возложен на вице-министра здравоохранения Республики Казахстан Байжунусова Э.А.

Приказ вводится в действие по истечении десяти календарных дней после его первого официального опубликования. По состоянию на 24.05.2013 года, приказ еще не введен в действие. Текст приказа будет опубликован в официальных СМИ.

Источник: Информационная служба ZAKON.KZ

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