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  3. Medical (general)

une instruction complète

English translation: a complete evaluation

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:une instruction complète
English translation:a complete evaluation

23:01 Feb 16, 2015
    The asker opted for community grading. The question was closed on 2015-02-20 10:54:14 based on peer agreement (or, if there were too few peer comments, asker preference.)


French to English translations [PRO]
Medical - Medical (general) / Standard Dossier on indication extension of a medicinal product
French term or phrase: une instruction complète
Hi again,

I thought I had already posted this query, but apparently not.

Here is the context of the phrase:

 Si des données nouvelles sont déposées par le laboratoire en cours d’instruction, la Commission de la transparence jugera, en fonction de leur importance, si elle peut ou non les prendre en compte dans les délais. Des nouvelles données ne peuvent être déposées pendant la phase contradictoire, sauf à faire l’objet d’une nouvelle demande et d’une instruction complète.

Thank you!
liz askew
United Kingdom
Local time: 18:56
a complete evaluation
Explanation:
It would require a fresh application and complete evaluation of the product.

www.ema.europa.eu/ema/pages/includes/document/open_document...
The European Agency for the Evaluation of Medicinal Products. Evaluation of Medicines for Human Use.
Selected response from:

B D Finch
France
Local time: 19:56
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2a complete evaluation
B D Finch
4complete procedure (for extension)
Drmanu49
4a complete (product) file
Caroline Schena
4 -2full instuctions
Angelina Galanska


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
complete procedure (for extension)


Explanation:
of marketing authorization

Drmanu49
France
Local time: 19:56
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 5346
Login to enter a peer comment (or grade)

4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -2
full instuctions


Explanation:
complet, complète
adjectif
(latin completus, rempli)

Qui comporte tous les éléments nécessaires, à quoi rien ne manque : Une collection complète des œuvres de Balzac.
Se dit d'une période envisagée dans sa totalité ; entier : Nous passerons un mois complet à la campagne.
Qui comporte un vaste ensemble d'éléments qui couvrent bien le domaine en question : Sa discothèque est assez complète.

En savoir plus sur http://www.larousse.fr/dictionnaires/francais/complet_complè...

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Note added at 4 hrs (2015-02-17 03:16:03 GMT)
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* instructions

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Note added at 4 hrs (2015-02-17 03:16:58 GMT)
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to be read: instructions

Angelina Galanska
United States
Specializes in field
Native speaker of: Native in BulgarianBulgarian
PRO pts in category: 7

Peer comments on this answer (and responses from the answerer)
disagree  Daryo: "full instuctions" (plain speak) has no connections with "une instruction complète [d'un dossier]" (bureaucratese a.k.a. "l'hexagonal")
5 mins
  -> ...sauf à faire l’objet d’une nouvelle demande et d’une instruction complète. ...except to be used in a new application and full set of instructions ...
disagree  B D Finch: You have misunderstood the meaning of "instruction" in French.
7 hrs
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7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
a complete (product) file


Explanation:
The transparency commission assesses new drugs through a series of procedures that have been established over time. When the industrial requests a market authorization, he has to bring a complete file (dossier) to the commission. The file contains all the product indications, administration methods, side effects, benefits and trials that have been done up to that point.

In the first part of your paragraph, "en cours d'instruction" means "being assessed/reviewed/evaluated."

In the last part of your paragraph, I believe it refers to a new request, which should be supported by a new "complete file".

Example sentence(s):
  • ...unless it\'s part of a new request and complete (product) file.
Caroline Schena
Italy
Local time: 19:56
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
Login to enter a peer comment (or grade)

11 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
a complete evaluation


Explanation:
It would require a fresh application and complete evaluation of the product.

www.ema.europa.eu/ema/pages/includes/document/open_document...
The European Agency for the Evaluation of Medicinal Products. Evaluation of Medicines for Human Use.

B D Finch
France
Local time: 19:56
Native speaker of: English
PRO pts in category: 100
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Daryo
57 mins
agree  John Holland
1 hr
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