Nov 19, 2008 20:18
15 yrs ago
10 viewers *
French term
Works in: French to English
titulaire de l'autorisation
French to English
Medical
Medical: Pharmaceuticals
titulaire de l'autorisation de mise sur le marche
Proposed translations
(English)
Proposed translations
+8
10 mins
Janet Ratziu
France
France
Native in English
Specializes in field
France
Translations with Medical Experience
Native in: English
Works in: French to English, English
Related KudoZ points
:
52
Selected
marketing authorization holder
marketing authorization holder
Guideline 117
- [ Traduire cette page ]
It is of importance for all parties, the Marketing Authorization Holders (MAHs), ... The Marketing Authorization Holder is the commercial party who, ...
www.fda.gov/cvm/Guidance/guide117.htm - 23k
Guideline 117
- [ Traduire cette page ]
It is of importance for all parties, the Marketing Authorization Holders (MAHs), ... The Marketing Authorization Holder is the commercial party who, ...
www.fda.gov/cvm/Guidance/guide117.htm - 23k
Peer comment(s):
| agree |
sktrans
5 mins
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Thanks sktrans!
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| agree |
Diane de Cicco
22 mins
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Thanks Diane!
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| agree |
Thais Maria Lips
49 mins
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Thank you Thais!
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| agree |
Helen Genevier
57 mins
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Thank you Helen!
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| agree |
mdcdc
2 hrs
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Thank you!
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| agree |
Rachel Fell
3 hrs
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Thank you Rachel!
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| agree |
Susan P Best
: S P Best
19 hrs
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Thank you Sue!
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| agree |
Angela Dickson (X)
1 day 11 hrs
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Thank you Angela!
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4 KudoZ points awarded for this answer.
Comment: "This was the first response, and it made sense. Thank you!"
+4
11 mins
Karen Tkaczyk
United States
United States
Native in English
Specializes in field
United States
PhD Chemicals/Pharmaceuticals/Cosmetics
Native in: English (Variants: US, British)
Works in: French to English, English
Related KudoZ points
:
170
French term (edited):
titulaire de l\\\'autorisation
Marketing Authorization Holder
The company who is authorised/authorized to market the drug. Standard term.
Peer comment(s):
| agree |
sktrans
4 mins
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Thanks
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| agree |
Helen Genevier
56 mins
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Thanks Helen
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| agree |
Rachel Fell
3 hrs
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Thanks Rachel
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| agree |
Angela Dickson (X)
1 day 11 hrs
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Thank you
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11 mins
Isabelle Berquin
Native in French
Specializes in field
PhD with a solid scientific background
Native in: French (Variants: Belgian, Standard-France) 
Works in: English to French, French to English
Related KudoZ points
:
12
1 hr
Pascale Dahan
United Kingdom
United Kingdom
Native in English
Specializes in field
United Kingdom
14 years in medical/pharmaceutical trans
Native in: English 
Works in: French to English, English to French
French term (edited):
titulaire de l\'autorisation
Manufacturer of the Licenced drug/ Licenced drug Manufacturer
Is what it means and is more common, I would say.
Example sentence:
NARCOTIC DRUGS ACT 1967 - SECT 4 Interpretation "manufacturer's licence" means a licence under section 9. "narcotic preparation" means any mixture, whether solid or liquid, that contains a drug. ...
+1
1 hr
manufacturer of the government approved drug
A drug manufacturer must submit its new drug product to the federal government's Health Products and Food Branch (HPFB) at Health Canada, for review and ...
www.health.gov.on.ca/english/public/pub/drugs/approved.html - 16k -
www.health.gov.on.ca/english/public/pub/drugs/approved.html - 16k -
Peer comment(s):
| agree |
Lionel_M (X)
: Oui ! J'ai du mal à comprendre ce que "marketing" a à voir avec une AMM
49 mins
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Merci Lionel, je reste perplexe... L'AMM n'est pas une licence.
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Karen Tkaczyk
: Hi guys. C'est parce que c'est le terme que l'UE utilise. L'autorisation de mise sur le marché se traduit par Marketing Authorisation AMM>MA
1 day 15 hrs
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Alors l'UE se trompe ! D'autre part il me semble que c'est pour les USA ou il n'y a aucun doute sur FDA approval.
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| agree |
MatthewLaSon
: Why do we have to abide by EU speak here if we have a North American audience? I think some folks are throwing disagrees around a little too much here for my liking. LOL.
2 days 5 hrs
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Exactly my point Matthew, I hope the asker and responders read yours comment. And "official" terms are often badly translated by non-pros, some not even used in the UK. Thank you.
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-1
2 hrs
commercial license holder
Hello,
They have a license to sell it? Isn't that what a company or person has in order to sell its products? a commercial license?
I hope this helps.
They have a license to sell it? Isn't that what a company or person has in order to sell its products? a commercial license?
I hope this helps.
Peer comment(s):
| disagree |
Angela Dickson (X)
: there's a very specific term for this in the context of European drug regulation, and this is not it.
1 day 9 hrs
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Thanks, Angela! But I'm not convinced either way. I'd have to invetsigate more for myself. Anyways, I gave myself a confidance level fof 5 by accident. I meant to put "3".
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Discussion
Updated weekly as a service by CDER's Division of Data Management and Services.
www.fda.gov/CDER/da/da.htm - 46k -
authorization holder:
The person or company in whose name the marketing authorization has been granted.
This party is responsible for all aspects of the product, including quality and compliance
with the conditions of marketing authorization.
http://healthtech.who.int/pq/info_general/documents/WHO_DMP_...