May 12, 2013 14:33
11 yrs ago
English term

variations / extensions to a marketing authorisation

English to Russian Medical Medical: Pharmaceuticals
This guideline is directed particularly at the requirements for demonstration of therapeutic equivalence between two inhaled products, in the context of abridged applications or variations / extensions to a marketing authorisation, used in the management and treatment of adult patients with asthma and/or COPD and children and adolescents with asthma.

Proposed translations

+1
20 mins
Selected

изменения / дополнения к регистрационному удостоверению

не знаю, как будете формулировать итоговое предложение, вариант:
... "в контексте ... или заявок на внесение изменений / дополнений в регистрационное удостоверение"
Peer comment(s):

agree Ekaterina Chashnikova
5 hrs
спасибо
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4 KudoZ points awarded for this answer.
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