Катрен СтильВ Госдуме предлагают упростить регистрацию дженериков ради импортозамещения
Депутаты Государственной думы готовят законопроект, который предусматривает запрет на заключение договоров, согласно которым лекарственные средства можно закупить только у одного поставщика или продавать через эксклюзивного дистрибьютора. Также законотворцы планируют сделать процедуру регистрации дженериков значительно проще. Об этом 17 мая на встрече с журналистами рассказал заместитель председателя Государственной думы Андрей Исаев.
Парламентарии от фракции «Единая Россия» планируют внести поправки в закон «Об обращении лекарственных средств», согласно которым контрагентам будет запрещено заключать контракты, предусматривающие получение лекарственных препаратов у единственного поставщика. Также будет введен запрет на разрешение продажи лекарственных средств через единственного дистрибьютора.
По словам главного инициатора поправок Андрея Исаева, такие меры необходимы для исключения монополии на фармацевтическом рынке.
Кроме этого, в законопроект будут включены поправки, упрощающие регистрацию дженериков. Согласно ч. 9 ст. 18 Федерального закона № 61‑ФЗ, если лекарственный препарат существует на рынке более 20 лет, то для регистрации его аналога необходимо предоставить результаты клинических испытаний или обзор научных работ по опыту применения оригинала. Депутаты предлагают исключить требование результатов испытаний, оставив только необходимость предоставлять обзор научных работ. Такая мера, по мнению парламентариев, ускорит регистрацию препаратов и будет способствовать импортозамещению.
Сейчас законопроект находится на обсуждении в Координационном совете по законотворческой деятельности и его готовят к внесению в Госдуму.
18 мая 2018
Выпуск: №172, май 20181187 просмотров
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