Важно: новые правила указания срока годности ЛС
5 марта 2020
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№194, март 2020
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Важно: новые правила указания срока годности ЛС
Коллегия Евразийской экономической комиссии приняла руководство по определению срока годности лекарственных препаратов, поступающих в оборот на территории ЕАЭС. Руководство распространяется на всех производителей из государств – членов экономического союза. Документ опубликован 3 марта на сайте коллегии ЕАЭК.
Согласно руководству, датой выпуска лекарственного препарата следует считать дату подписания разрешения на реализацию серии ЛС, подтверждающего соответствие серии всем необходимым требованиям, установленным лицензией, регистрационным досье и Правилами надлежащей производственной практики. Дата истечения срока годности серии ЛС должна отсчитываться от даты ее выпуска.
При этом дата выпуска не должна превышать 30 календарных дней со дня производства серии лекарственного препарата. Если необходимые документы подписаны позже этого периода, то срок годности серии следует начинать считать с даты ее производства — даты выполнения первой операции, связанной со смешиванием фармацевтической субстанции с другими ингредиентами.
Срок годности лекарственных препаратов необходимо указывать в формате ММ. ГГГГ или ММ/ГГГГ. Датой истечения срока годности, согласно руководству, считается последний день указанного месяца.
Для лекарственных препаратов, срок годности которых составляет менее 12 месяцев, дата истечения срока годности определяется путем прибавления срока годности к дате выпуска серии.
Для ЛС со сроком годности более 12 месяцев он вычисляется двумя способами:
- Если лекарственный препарат произведен позднее 15‑го числа месяца, то к сроку годности добавляется дата выпуска серии.
- Если препарат произведен до 15‑го числа месяца, то к сроку годности прибавляется дата выпуска серии, но при этом указывается предыдущий месяц, полученный после прибавления.
Катрен Стиль
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