подтверждение государственной регистрации

English translation: confirmation of state registration

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:подтверждение государственной регистрации
English translation:confirmation of state registration
Entered by: Sofia Gutkin

14:58 Feb 6, 2020
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals / Marketing authorisation
Russian term or phrase: подтверждение государственной регистрации
Требуется "официальный" английский термин, если возможно.

Контекст: Подтверждение государственной регистрации лекарственного средства осуществляется на основании переоценки соотношения "польза-риск", проводимой уполномоченным органом...

Спасибо!
Sofia Gutkin
Belgium
confirmation of state registration
Explanation:
лекарственное средство; лекарственный препарат; фармаконадзор; подтверждение государственной регистрации; safety; drug; pharmacovigilance; confirmation of state registration
Description Recommendations for the Marketing Authorisation Holders for the preparation of the document containing the results of the monitoring of safety of the drug, which is presented as part of the dossier at the state registration confirmation in 5 years after the initial registration of the drug in Russia are given. Links to legal documents, and specific examples of the proper execution of the relevant sections of the document are represented.

https://www.risksafety.ru/jour/oai?verb=ListRecords&set=jour...
Selected response from:

Frank Szmulowicz, Ph. D.
United States
Local time: 00:33
Grading comment
Thank you, I thought it may have been 're-registration' or the like.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2confirmation of state registration
Frank Szmulowicz, Ph. D.


  

Answers


9 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
confirmation of state registration


Explanation:
лекарственное средство; лекарственный препарат; фармаконадзор; подтверждение государственной регистрации; safety; drug; pharmacovigilance; confirmation of state registration
Description Recommendations for the Marketing Authorisation Holders for the preparation of the document containing the results of the monitoring of safety of the drug, which is presented as part of the dossier at the state registration confirmation in 5 years after the initial registration of the drug in Russia are given. Links to legal documents, and specific examples of the proper execution of the relevant sections of the document are represented.

https://www.risksafety.ru/jour/oai?verb=ListRecords&set=jour...

Frank Szmulowicz, Ph. D.
United States
Local time: 00:33
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 199
Grading comment
Thank you, I thought it may have been 're-registration' or the like.

Peer comments on this answer (and responses from the answerer)
agree  Ravindra Godbole
28 mins
  -> Thank you, Ravindra. Best regards!

agree  Liath Gleeson
3 hrs
  -> Thank you, Liath. Have a nice evening!
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