Sep 22, 2020 09:05
3 yrs ago
20 viewers *
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
(Russian)
5 +1 | приостановка выдачи сертификата | Natalie |
4 | Время, на которое приостанавливается получение ответа от регуляторных органов | Mark Rabkin |
3 | время(, отводимое) на подготовку ответов | Mikhail Zavidin |
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.
Если результат удаленной оценки не позволяет выдать сертификат GMP, то выдача сертификата будет приостановлена до тех пор, пока не станет возможной инспекция на месте.
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.
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.
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...
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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