Екатерина Чернявская
ginasanders / Depositphotos.com
Кабмин обновил не только указанные правила, но и Методику расчета предельных отпускных цен на лекарственные препараты, включенные в перечень ЖНВЛП, при их госрегистрации и перерегистрации (постановление Правительства РФ от 8 октября 2018 года № 1207 «О внесении изменений в постановления Правительства Российской Федерации от 29 октября 2010 г. № 865 и от 15 сентября 2015 г. № 979″1). Одно из главных новшеств – правило о том, что цены на дженерики не могут быть выше зарегистрированных цен на оригинальные лекарственные препараты.
Также новшества коснулись и перерегистрации цен на такие препараты. В частности, изменять зарегистрированные предельные отпускные цены производителя с целью их повышения можно будет осуществлять только один раз в календарный год. Однако для перерегистрации их сниженного размера ограничений не будет. Отметим, что основанием для перерегистрации увеличенной цены станет пакет документов для экономического анализа. Его методика определена указанным постановлением.
Документ вступит со дня его официального опубликования, однако на момент написания новости он еще не был опубликован.
Отметим, что 15 октября в Госдуму был внесен законопроект о введении уголовной ответственности за онлайн-продажу поддельных лекарств, включающей в себя санкцию в виде лишения свободы на срок от пяти до восьми лет с возможным штрафом лишением права занимать определенные должности или заниматься определенной деятельностью. Речь идет, в частности, об обращении фальсифицированных и недоброкачественных лекарств на сумму от 100 тыс. руб.
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1 С текстом постановления Правительства РФ от 29 октября 2010 г. № 865 «О государственном регулировании цен на лекарственные препараты, включенные в перечень жизненно необходимых и важнейших лекарственных препаратов» можно ознакомиться на официальном сайте Правительства РФ.
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