Glossary entry (derived from question below)
French term or phrase:
exploitant
English translation:
distributor / commercial operator
Added to glossary by
Gabrielle Lyons
Sep 27, 2005 14:27
19 yrs ago
70 viewers *
French term
The content matters.
Native in: English 
Works in: French to English, German to English
exploitant
French to English
Medical
Medical: Pharmaceuticals
pharmaceutical regulation
In relation to the AAM (authorisation de mise sure marché) and separate from the titulaire (MA holder)
Proposed translations
(English)
| 5 | distributor |
Nicholas Stedman
|
| 4 | manufacturer |
Dr Sue Levy (X)
|
| 3 | MA holder or its representative |
Helen Genevier
|
Proposed translations
4 hrs
Selected
distributor
the exploitant is not the manufacturer but the distributor
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Note added at 19 hrs 28 mins (2005-09-28 09:56:09 GMT)
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The marketing licence holder, manufacturer and distributor have different pharmaceutical responsibilities. Obviously drug companies are usually marketing licence holders, manufacturers and distributors of their own proprietary products in their home countries.
The word exploitant is normally used in French for companies that distribute the drugs manufactured by other companies for which they do not hold the marketing authorisation. On all french summary of product characteristics you have "nom de fabricant" followed by "nom d'exploitant"
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Note added at 23 hrs 19 mins (2005-09-28 13:46:45 GMT) Post-grading
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I don't know where your client got the expression commerical operator from. Try "marketing authorisation" "commercial operator" in google and there is not a single answer!
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Note added at 19 hrs 28 mins (2005-09-28 09:56:09 GMT)
--------------------------------------------------
The marketing licence holder, manufacturer and distributor have different pharmaceutical responsibilities. Obviously drug companies are usually marketing licence holders, manufacturers and distributors of their own proprietary products in their home countries.
The word exploitant is normally used in French for companies that distribute the drugs manufactured by other companies for which they do not hold the marketing authorisation. On all french summary of product characteristics you have "nom de fabricant" followed by "nom d'exploitant"
--------------------------------------------------
Note added at 23 hrs 19 mins (2005-09-28 13:46:45 GMT) Post-grading
--------------------------------------------------
I don't know where your client got the expression commerical operator from. Try "marketing authorisation" "commercial operator" in google and there is not a single answer!
4 KudoZ points awarded for this answer.
Comment: "My client's standard term is "commercial operator" to cover all possibilities- expoloitant is a fuzzy term - but you can have the points as you've convinced me yours is usually the best translation
Thanks"
17 mins
manufacturer
The following particulars shall be communicated to the competent authorities : name of corporate name and
permanent address of the person responsible for placing the medicinal product on the market and, where
applicable, of the manufacturer.
http://www.efpia.org/4_pos/sci_regu/respons.PDF
when the MAH is not the manufacturer, shall sign a written agreement with the manufacturer in order to guarantee that the manufacturing operations comply with the rules into force and with the manufacturing conditions provided for in the dossier;
http://www.vvkt.lt/t_aktai_en/tfiles/85.pdf
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Note added at 5 hrs 14 mins (2005-09-27 19:41:45 GMT)
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Found this (page 13):
http://pharmacos.eudra.org/F2/eudralex/vol-2/A/ctd-chap7_200...
The person responsible for placing the medicinal
product on the market in France (so called
“exploitant” in French) should be specified, knowing
that this “exploitant should be a pharmaceutical site.
So OK, it's not the manufacturer per se (but could well be). As far as licence holder is concerned, marketing authorisation is just another name for the licence. So the MAH is also the licence holder. The manufacturer will of course have a manufacturer's licence.
permanent address of the person responsible for placing the medicinal product on the market and, where
applicable, of the manufacturer.
http://www.efpia.org/4_pos/sci_regu/respons.PDF
when the MAH is not the manufacturer, shall sign a written agreement with the manufacturer in order to guarantee that the manufacturing operations comply with the rules into force and with the manufacturing conditions provided for in the dossier;
http://www.vvkt.lt/t_aktai_en/tfiles/85.pdf
--------------------------------------------------
Note added at 5 hrs 14 mins (2005-09-27 19:41:45 GMT)
--------------------------------------------------
Found this (page 13):
http://pharmacos.eudra.org/F2/eudralex/vol-2/A/ctd-chap7_200...
The person responsible for placing the medicinal
product on the market in France (so called
“exploitant” in French) should be specified, knowing
that this “exploitant should be a pharmaceutical site.
So OK, it's not the manufacturer per se (but could well be). As far as licence holder is concerned, marketing authorisation is just another name for the licence. So the MAH is also the licence holder. The manufacturer will of course have a manufacturer's licence.
17 hrs
MA holder or its representative
The link below contains this text, which suggests that the exploitant is either the MA holder (which seems to be the most common situation) or its representative if the MAH is not based in France.
"As an "exploitant", if the Marketing Authorisation Holder is not represented in the French Territory, we can, at Novex Pharma, be the representative of the MA Holder and we can organise the distribution of the drug with a distributor in the French Territory.
As the representative of our customer we:
Control the sales
Review and control the medical information for submission to the Commission de publicité at Agency,
Manage Pharmacovigilance and submission of serious events to Commission de Pharmacovigilance at Agency,
Supervise the traceability of batches (and recall if requested)"
"As an "exploitant", if the Marketing Authorisation Holder is not represented in the French Territory, we can, at Novex Pharma, be the representative of the MA Holder and we can organise the distribution of the drug with a distributor in the French Territory.
As the representative of our customer we:
Control the sales
Review and control the medical information for submission to the Commission de publicité at Agency,
Manage Pharmacovigilance and submission of serious events to Commission de Pharmacovigilance at Agency,
Supervise the traceability of batches (and recall if requested)"
Discussion