| English term or phrase: active moiety | Es geht erneut um die Erstzulassungsdaten von Arzneimitteln. Der Begriff "active moiety" kommt hier 2x vor -
Can you please provide proposals for harmonised birth dates of applicable products (...). It is strongly recommended that the date given is a single date for all products containing the same active substance for which you are MAH (Zulassungsinhaber). In this regard same active substance includes:
- different salts,
- esters or,
- complexes of the same *active moiety*.
There is no need to mention each salt separately, however, esters and other derivatives may have names which differ substantially from the name of the *active moiety* and should therefore be mentioned separately with the same birth date.
Ist damit nur "gleicher Wirkstoff" gemeint?
Vielen Dank für jede erhellende Info! |
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The translation workplace 
peer agreement (net): +3
