В ЕАЭС создали нормы для торговых наименований ЛС: они не должны быть созвучными
Коллегия Евразийской экономической комиссии приняла Руководство по выбору торговых наименований лекарственных препаратов. В нем содержатся рекомендации для производителей о том, как следует правильно создавать названия для лекарств, готовящихся к регистрации в ЕАЭС. Документ опубликован 30 января на сайте Евразийского экономического союза.
Согласно руководству, производителям не следует использовать такие торговые наименования, которые можно спутать в печатном или письменном виде с другими зарегистрированными препаратами. Это же касается и созвучия торговых наименований.
Также, чтобы не вызывать путаницы с дозировкой или режимом дозирования препарата, рекомендуется не использовать в названии отдельные буквенные или цифровые спецификаторы.
Кроме этого, в торговое наименование не следует включать математические символы (например, «+»), за исключением случаев, когда торговое наименование представляет собой МНН с комбинацией нескольких веществ.
Для оценки правильного формирования торговых наименований предлагается создать специальную экспертную организацию, которая будет следить за соблюдением выполнения рекомендаций.
Авторы документа отмечают, что действие руководства будет распространяться на лекарственные препараты, зарегистрированные в ЕАЭС после 31 декабря 2020 года.
31 января 2019
Фото: depositphotos.com
Выпуск: №180, январь 20192366 просмотров
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