Conor McAuley Oct 2, 2012:

MAH is not a million miles from my "licence-holder", I have to say, as marketing authorisation is licenced or sub-licenced, I believe. ;-) But you do need exactly the right terminology for these things, that's why we're here.

Nicholas Stedman Oct 2, 2012:

In this case the exploitant was also the MAH as is very often the case - your client chose to use the recognised European term rather than one specific to the French market but this does not mean you were wrong to put exploitant or that MAH is the right translation of exploitant

SJLD Oct 2, 2012:

hmmm

claude-andrew (asker) Oct 1, 2012:

The client's answer Exploitant : Marketing Authorization Holder

It wasn't too late to change from "exploitant"

claude-andrew (asker) Sep 25, 2012:

@Nikki and all Yes, this is exactly the layout in the text. Wonders will never cease.

Nikki Scott-Despaigne Sep 25, 2012:

@ Claude-Andrew Bravo for the miracle! ;-)
Are they actually meant to be on separate lines?

claude-andrew (asker) Sep 25, 2012:

@Nikki These are the actual symbols (miraculously reproduced here!)

Adam Warren Sep 25, 2012:

White square could be a displaced black square Which seems more logical. I agree with Pil Goddard about the meaning of "exploitant" - a commendably full explanation! In the Intellectual Property connection, "exploiter un brevet" is to "work a patent". This is the broad idea in "exploitant", as Phil points out.

Nikki Scott-Despaigne Sep 25, 2012:

@ Claude-Andrew In your list there is a square symbol between the terms "importateur" and "exploitant". Is this actually the symbol in your original, or is it a hyphen or a slash? I wonder if is not actually meant to be a square filled in and if "exploitant" is not actually on a line on its own bwteen "importateur" and "distributeur". Could you clarify please?
Cf : http://agence-prd.ansm.sante.fr/php/etapharm/aide.html
Treize catégories d'activités sont répertoriées dans l’article R. 5124-2 du Code de la santé publique (CSP) :

1° fabricant

2° importateur

3° exploitant

4° dépositaire... etc

philgoddard Sep 25, 2012:

I think you're all making it overcomplicated. An "exploitant" is just someone who exploits a product, ie sells or markets it. This may be as a licensee or MAH (titulaire de l'AMM), or it may make the products itself, but the French doesn't specify this.

SJLD Sep 25, 2012:

Yes, as you can see, there is quite a bit of overlap with wholesaler (distributeur).

claude-andrew (asker) Sep 25, 2012:

@SJLD Many thanks for your research. The client has given me 4 Oct. for delivery, so I have plenty of time to peruse your refs. I get the idea that it means the entity authorised to market the products. As it occurs just a single time in this inspection report, in the definition of the company, I don't feel too stressed about it. I've now found a clear definition of xploitant:
http://ansm.sante.fr/var/ansm_site/storage/original/applicat...

SJLD Sep 25, 2012:

cont'd There has been some confusion with regard to terms such as 'exploitant', 'technical director', 'distributor', etc. Since there is neither a commonly agreed understanding of these terms nor equivalent legal definitions of these terms amongst the EEA countries, and in the absence of any reference or definition in Community law, reference to such terminology will not be accepted for a medicinal product authorised by the Community.

It must be recalled that, under the case-law of the EC Court of Justice, EEA countries may not require that a local representative of the marketing authorisation holder be appointed for their territory. Therefore, the arrangements outlined above are purely optional for holders of Community marketing authorisations.

Attention should be drawn to the fact that in cases where the manufacturer is different from the marketing authorisation holder, only the actual manufacturer responsible for batch release should be mentioned in the package insert in addition to the marketing authorisation holder.

SJLD Sep 25, 2012:

EMA - definitive authority for EU http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...

Local Representative shall be taken to mean: any private or legal person established in the Community charged, through a civil contract with the marketing authorisation holder, with representing him in a defined (geographical) area; this contract excludes any transfer of any responsibility imposed on the marketing authorisation holder by Community law and by national law, regulation and administrative action implementing such Community law. Designation of a local representative cannot be a requirement but, when the holder of a Community marketing authorisation wishes to identify a local representative in the package insert, all of the Community must be covered so that the final user of the product in each EEA country has equivalent access to a representative of the marketing authorisation holder or a local company (e.g. local company branch).

SJLD Sep 25, 2012:

let's see what the eggspurts say :-)

This might help too:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...

A transfer of Marketing Authorisation (MA) is the procedure by which the MA is transferred from the existing Marketing Authorisation Holder (MAH) to a new MAH. Such a transfer may be needed e.g. in the event of a merger/acquisition where the MAH is taken over by another company and ceases to exist as a separate legal entity, or in the event that one company sells products and product rights to another.

claude-andrew (asker) Sep 25, 2012:

Licence holder I hadn't entirely rejected licence holder, what do you think?

SJLD Sep 25, 2012:

http://www.farmavita.net/content/view/382/84/1/2/

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

See slide 17:
Pharmacovigilance and Drug Safety - Health Care Conference ...
www.ehcca.com/presentations/intpharmacon2/3_02_3.ppt
File Format: Microsoft Powerpoint - Quick View
Pharmaceutical regulatory and compliance congress and best practices forum ... MAH and/or “Exploitant” (company commercializing the product) if not the same

SJLD Sep 25, 2012:

http://www.lmtavocats.com/fr/images_db/legal_framework_of_re...

If in addition a pharmaceutical laboratory is considered as a “trader”
(“exploitant”), it may wholesale its drugs to distributors and/or
pharmacies.

SJLD Sep 25, 2012:

have you rejected "licence holder"? http://www.proz.com/kudoz/french_to_english/medical:_pharmac...