Glossary entry (derived from question below)
anglais term or phrase:
Change of ownership
français translation:
changement de titulaire/soumissionnaire
Added to glossary by
Drmanu49
Aug 5, 2017 12:08
7 yrs ago
9 viewers *
anglais term
Change of ownership
anglais vers français
Médecine
Médecine (général)
QRD
16-043 Change of ownership application
Demande de changement de titulaire ?
Demande de changement de titulaire ?
Proposed translations
(français)
| 4 | changement de titulaire/soumissionnaire |
Drmanu49
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| 5 -3 | Demande de transfert d'autorisation de mise sur le marché |
Daryo
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Change log
Aug 26, 2017 09:10: Drmanu49 Created KOG entry
Proposed translations
43 minutes
Selected
changement de titulaire/soumissionnaire
Rédaction des informations produit - ANSM : Agence nationale de ...
ansm.sante.fr › Activités › Autorisations d...
Ces feuilles de styles respectent le modèle européen en vigueur ( Site EMA - QRD Template). Elles se présentent ... Pour les soumissions post-AMM, fournir :.
Groupe Amélioration des processus du 03/07/2014 - Ansm
ansm.sante.fr/var/ansm_site/storage/.../472ddf2df9f67cbe7c434d33bd0aa743.pdf
3 juil. 2014 - au fur et à mesures des soumissions des différents bilans. ... annexes de l'AMM avec le modèle européen « QRD template 9 » actuellement en vigueur. ... C/ Modalités de gestion des demandes de changement de titulaire ...
ansm.sante.fr › Activités › Autorisations d...
Ces feuilles de styles respectent le modèle européen en vigueur ( Site EMA - QRD Template). Elles se présentent ... Pour les soumissions post-AMM, fournir :.
Groupe Amélioration des processus du 03/07/2014 - Ansm
ansm.sante.fr/var/ansm_site/storage/.../472ddf2df9f67cbe7c434d33bd0aa743.pdf
3 juil. 2014 - au fur et à mesures des soumissions des différents bilans. ... annexes de l'AMM avec le modèle européen « QRD template 9 » actuellement en vigueur. ... C/ Modalités de gestion des demandes de changement de titulaire ...
Peer comment(s):
| disagree |
Daryo
: how can you be "soumissionnaire" for an already existing "license to sell" / you give one right answer (... titulaire) and one totally off-tangent (... soumissionnaire) that is NOT a synonym nor makes any sense.
1 heure
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I guess you don't understand the question.
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| agree |
gayd (X)
19 heures
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Thank you.
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| neutral |
Francois Boye
: Why 'soumissionnaire'? Is it relevant to a change of ownership in France?
1 jour 1 heure
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Yes it is a new application
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4 KudoZ points awarded for this answer.
Comment: "Merci à tous"
-3
2 heures
anglais term (edited):
Change of ownership application (medicines marketing authorisation)
Demande de transfert d'autorisation de mise sur le marché
the same procedure exists in France - no need to reinvent the wheel, just use the official terminology...
"You need to apply for a change of ownership to transfer a marketing authorisation (MA), also known as a product licence, to a new owner. You can do this as the current or new owner as long as the required documents are submitted with the form. "
https://www.gov.uk/guidance/medicines-marketing-authorisatio...
https://www.gov.uk/government/publications/medicines-marketi...
https://www.gov.uk/government/uploads/system/uploads/attachm...
Règlement (CE) n° 2141/96 de la Commission du 7 novembre 1996 concernant l’examen d’une demande de transfert d’autorisation de mise sur le marché d’un médicament relevant du champ d’application du règlement (CEE) n° 2309/93 du Conseil
http://www.it-asso.com/gxp/eudralex_v27/contents/vol-1/reg_1...
more:
https://www.google.co.uk/search?q=Demande de transfert d'aut...
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Note added at 2 days1 hr (2017-08-07 13:41:15 GMT)
--------------------------------------------------
nuances ....
this being an application to the authority issuing "marketing authorization (MA)/autorisation de mise sur le marché(AMM)" there is for sure in this story an applicant / soumissionnaire - the applicant for this "Change of ownership application"
BUT
the application itself [which IS the term to translate] IS NOT about changing any "applicant/soumissionnaire", the application is about changing the "ownership" of the "licence to sell" (i.e. the marketing authorization (MA)), and whoever is the "owner" of the MA is definitely not an "applicant to obtain the MA"
call it
Demand de changement de titulaire (de la MMA)
Demande de transfert d'autorisation de mise sur le marché
it's fundamentally the same
"You need to apply for a change of ownership to transfer a marketing authorisation (MA), also known as a product licence, to a new owner. You can do this as the current or new owner as long as the required documents are submitted with the form. "
https://www.gov.uk/guidance/medicines-marketing-authorisatio...
https://www.gov.uk/government/publications/medicines-marketi...
https://www.gov.uk/government/uploads/system/uploads/attachm...
Règlement (CE) n° 2141/96 de la Commission du 7 novembre 1996 concernant l’examen d’une demande de transfert d’autorisation de mise sur le marché d’un médicament relevant du champ d’application du règlement (CEE) n° 2309/93 du Conseil
http://www.it-asso.com/gxp/eudralex_v27/contents/vol-1/reg_1...
more:
https://www.google.co.uk/search?q=Demande de transfert d'aut...
--------------------------------------------------
Note added at 2 days1 hr (2017-08-07 13:41:15 GMT)
--------------------------------------------------
nuances ....
this being an application to the authority issuing "marketing authorization (MA)/autorisation de mise sur le marché(AMM)" there is for sure in this story an applicant / soumissionnaire - the applicant for this "Change of ownership application"
BUT
the application itself [which IS the term to translate] IS NOT about changing any "applicant/soumissionnaire", the application is about changing the "ownership" of the "licence to sell" (i.e. the marketing authorization (MA)), and whoever is the "owner" of the MA is definitely not an "applicant to obtain the MA"
call it
Demand de changement de titulaire (de la MMA)
Demande de transfert d'autorisation de mise sur le marché
it's fundamentally the same
Peer comment(s):
| disagree |
Drmanu49
: No this is definitely not what is meant in French sorry but your answer is completely out of context
4 heures
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seems like you like ignoring step 1: be sure of the meaning of the ST // "titulaire" and "soumissionnaire" are not interchangeable in meaning, not in a century of Sundays //FYI, that's basic SOP of any even moderately competent bureaucracy
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| disagree |
Francois Boye
: Agree with Drmanu49!
12 heures
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yeah, sure ....
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| disagree |
gayd (X)
: Agree with Drmanu49
17 heures
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yeah, sure .... an "application to change the applicant for something that's ALREADY approved" makes perfect sense ... (in some alternative logic, possibly!)
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Discussion
...
C/ Modalités de gestion des demandes de changement de titulaire (transfert) et/ou d’exploitant d’AMM (Cf. présentation en annexe)
...
http://ansm.sante.fr/var/ansm_site/storage/original/applicat... p.4 (the correct link, BTW)
where do you see anywhere in it any mention of "demandes de changement de soumissionnaire"
or maybe I should understand that "titulaire" is an undercover name (/ pen name ?)for "soumissionnaire" ???