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  3. Medical: Pharmaceuticals

Variation Application

French translation: demande de modification

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Variation Application
French translation:demande de modification
Entered by: FX Fraipont (X)

07:12 Aug 28, 2013
English to French translations [PRO]
Medical - Medical: Pharmaceuticals / AMM
English term or phrase: Variation Application
Submission of a Variation Application Dossier
Le terme exact pour une modif d'AMM auprès de l'EMA ?
orgogozo
France
Local time: 03:30
demande de modification
Explanation:
"Parties - EUR-Lex - Simple search
htp://eur-lex.europa.eu/Notice.do?...‎Translate this page
In order to validate such a variation application the EMEA checks whether all ... Pour valider une telle demande de modification, l'[EMEA] vérifie si toutes les ..."
Selected response from:

FX Fraipont (X)
Belgium
Local time: 03:30
Grading comment
Merci à tous. En fait ils utilisent "variation". Pas terrible. Je préférais "modification"
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3demande de modification
CFournier
4 +2demande de modification
FX Fraipont (X)


Discussion entries: 3





  

Answers


12 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
variation application
demande de modification


Explanation:
"Parties - EUR-Lex - Simple search
htp://eur-lex.europa.eu/Notice.do?...‎Translate this page
In order to validate such a variation application the EMEA checks whether all ... Pour valider une telle demande de modification, l'[EMEA] vérifie si toutes les ..."

FX Fraipont (X)
Belgium
Local time: 03:30
Native speaker of: Native in FrenchFrench
PRO pts in category: 306
Grading comment
Merci à tous. En fait ils utilisent "variation". Pas terrible. Je préférais "modification"

Peer comments on this answer (and responses from the answerer)
agree  Bertrand Leduc
4 mins
  -> merci!
agree  Catcressie
2 hrs
  -> merci!
Login to enter a peer comment (or grade)

12 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
variation application
demande de modification


Explanation:
"Il y a lieu de noter que la documentation générale
devant accompagner toute demande de modification des termes
de l’autorisation de mise sur le marché (AMM) est précisée à
l’annexe IV du règlement «Modifications» ainsi que dans les lignes
directrices de la Commission sur le fonctionnement des procédu­
res établies aux chapitres  II, III et  IV du règlement (CE)
n
o
1234/2008 de la Commission du 24 novembre 2008 concer­
nant l’examen des modifications des termes d’une autorisation de
mise sur le marché de médicaments à usage humain et de médi­
caments vétérinaires"

"It should be noted that the general documentation
accompanying every application for variations to the term of a
marketing authorisation is laid down in Annex  IV to the varia­
tions Regulation and in the Commission guideline on the opera­
tion of the procedures laid down in Chapters II, III and  IV of
Commission Regulation (EC) No  1234/2008 of 24  November
2008 concerning the examination of variations to the terms of
marketing authorisations for medicinal products for human use
and veterinary medicinal products"


--------------------------------------------------
Note added at 13 minutes (2013-08-28 07:26:35 GMT)
--------------------------------------------------

Le règlement CE qui en parle (versions EN et FR) :

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2...

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2...


    Reference: http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_...
    Reference: http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_...
CFournier
France
Local time: 03:30
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 67

Peer comments on this answer (and responses from the answerer)
agree  Bertrand Leduc
5 mins
  -> merci
agree  Platary (X)
1 hr
  -> merci
agree  GILLES MEUNIER: parfaitement référencé
1 hr
  -> merci !
Login to enter a peer comment (or grade)



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