dossiers de variation

German translation: Zulassungsänderung / Änderung einer Zulassung

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:dossiers de variation (pharma)
German translation:Zulassungsänderung / Änderung einer Zulassung
Entered by: Harald Moelzer (medical-translator)

04:59 May 15, 2009
French to German translations [PRO]
Medical - Medical: Pharmaceuticals / Schweiz
French term or phrase: dossiers de variation
Aus einer Stellenausschreibung in der Pharmazeutik:

"Mission
... Préparer et soumettre les **dossiers de variation**.
Préparer les adaptations des textes d'information professionnelle et d'information pour les patients, ..."

Besten Dank im Voraus
Artur Heinrich
Belgium
Local time: 21:00
Zulassungsänderung / Änderung einer Zulassung
Explanation:
"...Format CTD pour les dossiers de variation. • Modification des règlements 541/95 et. 542/95..."
www.acqme.org/fichiers pdf colloque 03/duliere_acqme03.pdf

"Verordnung (EG) Nr. 541/95 der Kommission vom 10. März 1995 über die Prüfung von Änderungen einer Zulassung..."
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celex...
Selected response from:

Harald Moelzer (medical-translator)
Germany
Local time: 21:00
Grading comment
Prima!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2Zulassungsänderung / Änderung einer Zulassung
Harald Moelzer (medical-translator)


  

Answers


31 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
Zulassungsänderung / Änderung einer Zulassung


Explanation:
"...Format CTD pour les dossiers de variation. • Modification des règlements 541/95 et. 542/95..."
www.acqme.org/fichiers pdf colloque 03/duliere_acqme03.pdf

"Verordnung (EG) Nr. 541/95 der Kommission vom 10. März 1995 über die Prüfung von Änderungen einer Zulassung..."
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celex...


Harald Moelzer (medical-translator)
Germany
Local time: 21:00
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 53
Grading comment
Prima!

Peer comments on this answer (and responses from the answerer)
agree  Marga Shaw
30 mins
  -> Dankeschön, Marga!

agree  Gabriele Beckmann
1 hr
  -> Dankeschön, Gabriele!
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