Sep 22, 2020 09:05
3 yrs ago
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English term

clock-stop

English to Russian Medical Medical: Pharmaceuticals фармакология
If the outcome of the distant assessment does not permit the granting of the GMP certificate, a clock-stop will be triggered until an on-site inspection is possible. Как я поняла это время, необходимое для предоставления ответа

Proposed translations

+1
4 hrs
Selected

приостановка выдачи сертификата

а не выдачи некоего ответа ("ответ" здесь ни при чем: в центре должна быть проведена инспекция)

Если результат удаленной оценки не позволяет выдать сертификат GMP, то выдача сертификата будет приостановлена до тех пор, пока не станет возможной инспекция на месте.
Peer comment(s):

agree Erzsébet Czopyk
9 hrs
Спасибо!
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3 KudoZ points awarded for this answer.
36 mins

Время, на которое приостанавливается получение ответа от регуляторных органов

https://www.ema.europa.eu/en/glossary/clock-stop

Clock stop

A period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.


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44 mins

время(, отводимое) на подготовку ответов

In addition, the revised procedure gives developers more time to respond to questions raised by the committees by allowing longer clock-stops (the time period in which the company prepares answers to questions from EMA's committees).

https://www.ema.europa.eu/en/news/evaluation-advanced-therap...

Clock stop
A period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.

https://www.ema.europa.eu/en/about-us/about-website/glossary...
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