Катрен СтильМинздрав предложил новые условия регистрации ЛС
Ведомство представило проект поправок в закон № 61‑ФЗ «Об обращении лекарственных средств», которые обяжут фармацевтических производителей при регистрации новых ЛС иметь действующий в России патент на препарат, а также регистрировать торговый знак, под которым планируется выход ЛС на рынок. Текст поправок опубликован 25 октября.
Поправки разработаны в соответствии с 30‑й статьей Договора о Евразийском экономическом союзе, которая подразумевает создание на территории Союза общего рынка лекарственных средств. В связи с этим в законы стран-участниц необходимо внести изменения схожего характера.
Предлагаемые Минздравом поправки призваны защитить права держателей патентов на интеллектуальную собственность. Для регистрации ЛС на территории России производитель должен будет указывать сведения о наличии патента на предлагаемый к регистрации препарат. Причем патент должен быть действителен на территории стран Союза. Альтернатива патенту — лицензионное соглашение, разрешающее производство и продажу препарата (в случае, если заявитель не является владельцем патента).
Кроме этого, при регистрации ЛС станет необходимо предоставлять свидетельство о регистрации товарного знака, под которым препарат поступит в реализацию. И в заключение, ко всем документам необходимо будет прикладывать письменное подтверждение заявителя, что регистрация препарата не нарушает права третьих лиц на интеллектуальную собственность.
О разработке подобного законопроекта Минздрав объявил еще в сентябре этого года, однако текст документа так и не был опубликован.
26 октября 2018
Выпуск: №177, октябрь 20181659 просмотров
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