outside the terms of the marketing authorisation

16:41 Feb 7, 2020
English to Russian translations [PRO]
Medical: Pharmaceuticals
English term or phrase: outside the terms of the marketing authorisation
Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation
esperansa2016
Ukraine


Summary of answers provided
4 +1за пределами условий разрешения на маркетинг
Cherepanov
4 -1вне срока действия регистрационного свидетельства
Stanislav Korobov


  

Answers


24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
вне срока действия регистрационного свидетельства


Explanation:


--------------------------------------------------
Note added at 29 mins (2020-02-07 17:10:31 GMT)
--------------------------------------------------

Т.е. "вне" подразумевает, видимо, "до начала" и "по окончании" этого срока

Stanislav Korobov
Ukraine
Local time: 22:44
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1169

Peer comments on this answer (and responses from the answerer)
disagree  Natalie: вне срока действия регистрационного свидетельства препарат вообще не годен к применению
3 hrs
Login to enter a peer comment (or grade)

46 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
за пределами условий разрешения на маркетинг


Explanation:
Или, хоть и в ветеринарии, но та же суть: "за пределами условий регистрационного удостоверения":

http://fishquality.ru/assets/files/Documents on activities

/Regulations,%20standards/EU/%D0%A0%D0%B5%D0%B3%D0%BB%D0%B0%D0%BC%D0%B5%D0%BD%D1%82%20(%D0%95%D0%A1)%202019_6%20-%20%D0%9E%20%D0%B2%D0%B5%D1%82%D0%B5%D1%80.%D0%BB%D0%B5%D0%BA%D0%B0%D1%80%D1%81%D1%82.%D0%BF%D1%80%D0%B5%D0%BF%D0%B0%D1%80%D0%B0%D1%82%D0%B0%D1%85.pdf

Применение лекарственных препаратов за пределами условий регистрационного удостоверения у непродуктивных видов животных
...

acto-russia.org › files › reglament_536_16042014

Регламент (ЕС) N 536/2014 Европейского Парламента и ...

... К опубликованным научным данным, подтверждающим безопасность и эффективность исследуемого лекарственного средства, используемого не в соответствии с условиями разрешения на маркетинг, могут относиться...

...medicinal product not used in accordance with the terms of the marketing authorisation could include...

Cherepanov
Ukraine
Local time: 22:44
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 913

Peer comments on this answer (and responses from the answerer)
agree  Natalie
2 hrs
  -> Спасибо!
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:

Your current localization setting

English

Select a language

Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search