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Минсельхоз России проводит публичное обсуждение Правил регулирования обращения ветеринарных лекарственных средств на таможенной территории Евразийского экономического союза

Минсельхоз России проводит публичное обсуждение Правил регулирования обращения ветеринарных лекарственных средств на таможенной территории Евразийского экономического союза 08.05.2018

Минсельхоз России проводит публичное обсуждение Правил регулирования обращения ветеринарных лекарственных средств на таможенной территории Евразийского экономического союза

Правила определяют единые принципы и правила регулирования обращения ветеринарных лекарственных средств на таможенной территории Союза.

Действие настоящих Правил распространяется на производителей ветеринарных лекарственных средств, правообладателей ветеринарных лекарственных препаратов, их доверенных лиц, уполномоченные органы государств-членов, экспертные учреждения государств-членов, организации, осуществляющие реализацию ветеринарных лекарственных средств и других субъектов обращения ветеринарных лекарственных средств.

В Правилах содержатся термины и определения, в частности:

«ветеринарный лекарственный препарат» – ветеринарное лекарственное средство в виде лекарственной формы; 

«ветеринарный лекарственный препарат воспроизведенный (дженерик)» –– ветеринарный лекарственный препарат, который имеет такой же количественный и качественный состав действующих веществ и ту же лекарственную форму, что и оригинальный препарат и биоэквивалентность которого оригинальному ветеринарному лекарственному препарату подтверждается соответствующими исследованиями биодоступности (различные соли, эфиры, изомеры, смеси изомеров, комплексы или производные действующего вещества признаются одним и тем же действующим веществом, если их безопасность и эффективность существенно не отличаются); 

«ветеринарный лекарственный препарат оригинальный (референтный)» – ветеринарный лекарственный препарат, впервые зарегистрированный на территории Союза, на основании регистрационного досье ветеринарного лекарственного препарата, содержащего результаты полных доклинических и клинических исследований, подтверждающих его качество, безопасность и эффективность;

«ветеринарное лекарственное средство» – средство, представляющее собой вещество или содержащее данное вещество или комбинацию веществ, вступающее в контакт с организмом  животного, предназначенное для лечения, профилактики  болезней животных,  реабилитации, коррекции или изменения физиологических функций организма животного, сохранения, предотвращения или прерывания беременности, эвтаназии, а также для диагностики болезней животных (за исключением веществ или их комбинаций, не контактирующих с организмом животного);

«обращение ветеринарных лекарственных средств» - деятельность, включающая процессы разработки, доклинических исследований, клинических исследований, экспертизы, регистрации и иных процедур, связанных с регистрацией, контроля качества, оценки безопасности и эффективности, производства, изготовления, хранения, транспортировки, перемещения с территории одного государства – члена на территории других государств – членов, транзита, ввоза (вывоза) на(с) таможенную(ой) территорию(ии) Союза, рекламы, отпуска, реализации, передачи, применения, уничтожения ветеринарных лекарственных средств;

Выпуск в обращение на таможенной территории Союза ветеринарных лекарственных препаратов, зарегистрированных в соответствии с требованиями государств-членов до даты вступления в силу настоящих Правил, допускается до 31 декабря 2025 года с учетом условий, определенных пунктом 207 настоящих Правил.

Ветеринарные лекарственные препараты, произведенные и (или) ввезенные на таможенную территорию Союза в соответствии с требованиями законодательства государств-членов до 31 декабря 2025 года, могут обращаться на территории Союза до окончания срока их годности с учетом условий, определенных пунктом 207 настоящих Правил.

Пунктом 207 предусмотрено, что заявление на приведение регистрационного досье должно быть подано:

а) для ветеринарных лекарственных препаратов, имеющих в соответствии с законодательством государства-члена ограниченный срок действия регистрации (срочная регистрация), не позднее чем за 250 рабочих дней до окончания срока действия регистрации ветеринарного лекарственного препарата;

б) для ветеринарных лекарственных препаратов, имеющих в соответствии с законодательством государства-члена неограниченный срок действия регистрации (бессрочная регистрация), не позднее чем за 250 рабочих дней до 31 декабря 2025 года.

Публичное обсуждение Правил проводится до 4 июня 2018 г. 

С полным текстом правил можно ознакомиться здесь.
Со всеми приложениями Правил можно ознакомиться по ссылке

См. также проект Решения Евразийского экономического союза о Правилах регулирования обращения ветеринарных лекарственных средств




Источник:  spzoo.ru

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