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DRUG MASTER FILE

French translation: See below

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:DRUG MASTER FILE
French translation:See below
Entered by: sktrans
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07:37 Oct 23, 2000
English to French translations [PRO]
Medical
English term or phrase: DRUG MASTER FILE
AA was able to obtain a copy of the closed part of the DRUG MASTER FILE will all the details pertaining to the process [...] which the French Agency for the Safety of Health Products (AFSSAPS) has handed over.
Sylvie André
France
Local time: 14:09
See below
Explanation:
I have to disagree with the first response: Dossier d'AMM which refers to a Drug Product Application that is submitted to an official agency (here the FDA) for approval to be marketed.

DMFs are different: there are 5 types of DMFs: Type I deals with the manufacturing site, facilities, operating procedures, and personnel.
Type II deals with Drug Substance, Drug substance intermediate, and material used intheir preparation, or Drug product.
Type III deals with packaging material.
Type IV deals deals with excipient, colorant, flavor, essence, or material used intheir preparation
Type V deals with FDA - accepted reference information.

Now, based on the above, I do not understand if for your case you are dealing with the process of a drug product, substance, colorant, excipient, etc..
Based on your text, you will have to decide what to name it with the information I provided you. Ex: "Dossier de la spécialité pharmaceutique" or " Dossier du colorant" etc..

I hope this is helpful.
Selected response from:

sktrans
Local time: 08:09
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
naSee belowsktrans
naFICHIER PRINCIPAL DES MÉDICAMENTS
Marc Dionne
naDossier d'Autorisation de Mise su le Marché
Anne Palaysi


  

Answers


1 hr
Dossier d'Autorisation de Mise su le Marché


Explanation:
Dossier d'AMM = dossier d'Autorisation de Mise sur le Marché : this is the registration file that contains the manufacturing progess, clinical trials, quality control assays and many other information required to put a new drug on the market.

Anne Palaysi
France
Local time: 14:09
Native speaker of: French
PRO pts in pair: 50
Login to enter a peer comment (or grade)

3 hrs
FICHIER PRINCIPAL DES MÉDICAMENTS


Explanation:
Je ne crois pas qu'il s'agisse d'un terme technique en soit.

Dans Termium, on trouve « fichier maître » ou « fichier principal » pour « master file ».

Selon le nom de l'organisme, je pense bien qu'on parle de médicaments.

Bonne chance,

Marc


    Reference: http://www.termium.com
Marc Dionne
Canada
Local time: 08:09
Native speaker of: Native in FrenchFrench
PRO pts in pair: 51
Login to enter a peer comment (or grade)

10 hrs
See below


Explanation:
I have to disagree with the first response: Dossier d'AMM which refers to a Drug Product Application that is submitted to an official agency (here the FDA) for approval to be marketed.

DMFs are different: there are 5 types of DMFs: Type I deals with the manufacturing site, facilities, operating procedures, and personnel.
Type II deals with Drug Substance, Drug substance intermediate, and material used intheir preparation, or Drug product.
Type III deals with packaging material.
Type IV deals deals with excipient, colorant, flavor, essence, or material used intheir preparation
Type V deals with FDA - accepted reference information.

Now, based on the above, I do not understand if for your case you are dealing with the process of a drug product, substance, colorant, excipient, etc..
Based on your text, you will have to decide what to name it with the information I provided you. Ex: "Dossier de la spécialité pharmaceutique" or " Dossier du colorant" etc..

I hope this is helpful.


    FDA guidelines for DMFs.
sktrans
Local time: 08:09
Native speaker of: Native in ArabicArabic, Native in FrenchFrench
PRO pts in pair: 697
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Changes made by editors
Nov 29, 2010 - Changes made by sktrans:
Created KOG entryKudoZ term » KOG term


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