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Autorisation de Mise sur le Marché (AMM)

English translation: Marketing Authorization

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:Autorisation de Mise sur le Marché
English translation:Marketing Authorization
Entered by: Jonathan MacKerron
Options:
- Contribute to this entry
- Include in personal glossary

18:56 Oct 21, 2002
French to English translations [PRO]
Medical
French term or phrase: Autorisation de Mise sur le Marché (AMM)
is this the "Product Information Leaflet"?
Jonathan MacKerron
Marketing authorization
Explanation:
Everything is correct in Deborah's solution except for the missing -ing at the end of market.
The person, company, who receives the authorization is the Marketing Authorization Holder.
(Product information leaflet is a mule from Patient information leaflet, i.e. package insert and Product information brochure, i.e. Summary of Product Characteristics (SPC).
Selected response from:

xxxszeleczky
Hungary
Local time: 20:53
Grading comment
Thanks to all!
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +4Marketing authorizationxxxszeleczky
5 +1marketing authorization (MA)mami_ladka
4 +2Market Authorization
GILOU
3 +2Drug Marketing Authorization/ LicensingPascale Dahan
4 -1Authorize for Marketing
Paulette Racine Walden


Discussion entries: 1





  

Answers


1 min   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
Market Authorization


Explanation:
-

--------------------------------------------------
Note added at 2002-10-21 19:00:16 (GMT)
--------------------------------------------------

Domaine(s)
  – Genetics
  – Pharmacology
Domaine(s)
  – Génétique
  – Pharmacologie
 
Market Authorization
Source CORRECT

autorisation de mise
sur le marché Source
CORRECT, FÉM

  AMM Source CORRECT, FÉM

CONT – After successful
completion of the Phase II/III
clinical trials in infants, the
Pharming/Genzyme joint
venture will apply for product
approval for this population.
Completion of this clinical
trial, assessment of results,
filing of the application and
review by the FDA may take
as long as 12-24 months. In
Europe, we must complete a
Market Authorization.
Application with the EMEA,
the central European
regulatory body, to obtain
approval in the member
states of the European Union.
Source

CONT – L\'autorisation relative
aux produits médicaux
manufacturés par l\'industrie -
pertinente pour une mise sur
le marché - est sous la
responsabilité des autorités
compétentes en matière
harmaceutique [...] Ainsi, un
fabricant industriel souhaitera
obtenir une AMM [autorisation
de mise sur le marché]
européenne centralisée.

GILOU
France
Local time: 20:53
Native speaker of: Native in FrenchFrench
PRO pts in pair: 2482

Peer comments on this answer (and responses from the answerer)
agree  Deborah James
43 mins

agree  xxxszeleczky
1 hr
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11 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
Authorize for Marketing


Explanation:
Because it seems to be the correct answer, in this instance.

Paulette Racine Walden
Local time: 14:53
Native speaker of: Native in FrenchFrench, Native in EnglishEnglish
PRO pts in pair: 18

Peer comments on this answer (and responses from the answerer)
disagree  xxxszeleczky: Its a procedure (with fixed terminology) and not an action
1 hr
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1 hr   confidence: Answerer confidence 5/5 peer agreement (net): +4
Marketing authorization


Explanation:
Everything is correct in Deborah's solution except for the missing -ing at the end of market.
The person, company, who receives the authorization is the Marketing Authorization Holder.
(Product information leaflet is a mule from Patient information leaflet, i.e. package insert and Product information brochure, i.e. Summary of Product Characteristics (SPC).

xxxszeleczky
Hungary
Local time: 20:53
Native speaker of: Native in HungarianHungarian
PRO pts in pair: 7
Grading comment
Thanks to all!

Peer comments on this answer (and responses from the answerer)
agree  Martine Ascensio
34 mins

agree  Helen Genevier: in answer to the asker's note, I'd put "...patients fulfil the IFN MA criteria". Patients don't need to read the MA themselves.
11 hrs

agree  xxxMedic: Cave! This is the European (British) term. In USA the term approval is used instead of authorization.
13 hrs

agree  Yngve Roennike: xxxMedic is right. Also, approval for market introduction
1318 days
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11 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
marketing authorization (MA)


Explanation:
I agree with the previous answer and am adding the abbreviation since it is also contained in the question.

mami_ladka
Local time: 20:53
Native speaker of: Native in SlovenianSlovenian
PRO pts in pair: 27

Peer comments on this answer (and responses from the answerer)
agree  Helen Genevier
1 hr
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13 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
Drug Marketing Authorization/ Licensing


Explanation:
see ClinicalTrials.gov

Pascale Dahan
United States
Local time: 11:53
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 81

Peer comments on this answer (and responses from the answerer)
agree  Yolanda Broad
1 day8 hrs

agree  Jacqueline McKay
15 days
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