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A.I.C.

English translation: marketing authorisation

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Italian term or phrase:autorizzazione all'immissione in commercio (AIC)
English translation:marketing authorisation
Entered by: Gilberto Lacchia
Options:
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21:19 Feb 16, 2008
Italian to English translations [PRO]
Medical - Medical (general)
Italian term or phrase: A.I.C.
Autorizzazione all'Immissione in Commercio

what is the official american version of this authorization?

Trading authorization/permit???
Alessandra Manzotti Bunch
Local time: 10:46
marketing authorisation
Explanation:
And MAH is the "marketing authorisation holder"


http://www.emea.europa.eu/htms/human/withdraw/withdraw.htm


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Note added at 17 min (2008-02-16 21:37:26 GMT)
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2.3.3 Marketing Authorization Holder/Manufacturer/Distributor Section
2.3.4 Marketing Authorization Section
http://www.fda.gov/CbER/gdlns/ichm5.htm

Products where manufacturing process changes are made in development or for which a marketing authorization has been granted.
... to support the marketing authorization.
...drug product on behalf of the marketing authorization holder
http://www.fda.gov/CDER/GUIDANCE/6677fnl.htm
Selected response from:

Gilberto Lacchia
Italy
Local time: 16:46
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3marketing authorisation
Gilberto Lacchia


  

Answers


8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
marketing authorisation


Explanation:
And MAH is the "marketing authorisation holder"


http://www.emea.europa.eu/htms/human/withdraw/withdraw.htm


--------------------------------------------------
Note added at 17 min (2008-02-16 21:37:26 GMT)
--------------------------------------------------

2.3.3 Marketing Authorization Holder/Manufacturer/Distributor Section
2.3.4 Marketing Authorization Section
http://www.fda.gov/CbER/gdlns/ichm5.htm

Products where manufacturing process changes are made in development or for which a marketing authorization has been granted.
... to support the marketing authorization.
...drug product on behalf of the marketing authorization holder
http://www.fda.gov/CDER/GUIDANCE/6677fnl.htm

Gilberto Lacchia
Italy
Local time: 16:46
Specializes in field
Native speaker of: Italian
PRO pts in category: 1064

Peer comments on this answer (and responses from the answerer)
agree  Rachel Fell: probably marketing authorization for the US
1 hr

agree  Alexander Chisholm
12 hrs

agree  Desiree Bonfiglio
21 hrs
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Changes made by editors
Feb 23, 2008 - Changes made by Gilberto Lacchia:
Created KOG entryKudoZ term » KOG term


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