Glossary entry (derived from question below)
português term or phrase:
Titular da Autorização de Introdução no Mercado:
inglês translation:
Marketing approval holder (US)/Marketing authorization holder (UK)
Added to glossary by
Elizabeth Lyons
Oct 27, 2005 05:44
18 yrs ago
12 viewers *
português term
Estados Unidos
Scientist / Linguist
Native in: inglês (Variants: UK, US) 
Works in: francês para inglês, italiano para inglês, português para inglês, and 2 more.
Titular da Autorização de Introdução no Mercado:
português para inglês
Medicina
Medicina: farmacêutica
Product labels - legal-style language
I am working on a pharmaceutical product line being launched in a number of countries by a company based in the UK. Maybe this is obvious, but I just don't like any of the ways I translated this and am thinking that there may be a looser, more idiomatic legal-style phrase that is less Latinate than the ones I come up with.
Any suggestions would be welcomed!
MTIA.
Any suggestions would be welcomed!
MTIA.
Proposed translations
(inglês)
Proposed translations
1 hora
Norbert Hermann
Native in inglês
YOUR COMPETITIVE EDGE - over 40 YEARS!
Native in: inglês , alemão
Works in: inglês para alemão, alemão para inglês, português para alemão, and 3 more.
Related KudoZ points
:
4
português term (edited):
Titular da Autoriza��o de Introdu��o no Mercado:
Selected
(consent) holder of marketing approval/the approval for placing on the market (official EU trans.).
might be different for the US
placing on the market (official EU translation).
COMMISSION DECISION 96/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans
europa.eu.int/scadplus/leg/en/lvb/l21158.htm
A Commission Decision is a formal legislative act with an official version in each of the national languages of the EU. The above is the title of the English version, which forms part of the law of the UK and Ireland.
... COMMENTS OR OBJECTIONS TO THE PLACING ON THE MARKET OF A ... 1829/2003 and that oil from Ms8xRf3 already has. approval for placing on the market under Regulation 258/97 ...
www.defra.gov.uk/Environment/gm/regulation/pdf/c-be-96-01.p...
placing on the market (official EU translation).
COMMISSION DECISION 96/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans
europa.eu.int/scadplus/leg/en/lvb/l21158.htm
A Commission Decision is a formal legislative act with an official version in each of the national languages of the EU. The above is the title of the English version, which forms part of the law of the UK and Ireland.
... COMMENTS OR OBJECTIONS TO THE PLACING ON THE MARKET OF A ... 1829/2003 and that oil from Ms8xRf3 already has. approval for placing on the market under Regulation 258/97 ...
www.defra.gov.uk/Environment/gm/regulation/pdf/c-be-96-01.p...
4 KudoZ points awarded for this answer.
Comment: "Hermann, you were first for this version. Thank you to everyone for your informative answers. This was for a US audience, hence my selection. I wish I could give points to all. "
+5
9 minutos
Andrés Martínez
Espanha
Espanha
Specializes in field
Espanha
Biologist -Biol Biotech Med Pharm Vet
Native in: espanhol (Variant: Standard-Spain) 
, catalão (Variant: Central)
Works in: inglês para espanhol, espanhol, catalão para espanhol, and 2 more.
Related KudoZ points
:
16
português term (edited):
Titular da Autoriza��o de Introdu��o no Mercado:
Marketing authorisation holder
The usual one (FDA and EMEA).
ICH; Draft Guideline: M5 Data Elements and Standards for Drug ... - [ 2.3.3 ***Marketing Authorization Holder***/Manufacturer/Distributor Section ...
This draft guidance, when finalized, will represent the Food and Drug ...
www.fda.gov/cber/gdlns/ichm5.htm
[PDF] M5 Step 2 - Data elements and standards for drug dictionaries
information exchange during the drug development phase, the drug evaluation ...
***marketing authorization holder*** for authorized medicinal products, or to the ...
www.emea.eu.int/pdfs/human/ich/16853505en.pdf
DOC] VICH STEERING COMMITTEE
Food and Drug Administration. Center for Veterinary Medicine ... The ***Marketing Authorization Holder*** is the commercial party who, according to the national ...
www.fda.gov/cvm/Guidance/dGl24a.doc
Peer comment(s):
| agree |
Kathleen Goldsmith-Killing
6 horas
|
|
Thank you Kathleen.
|
|
| agree |
Enza Longo
6 horas
|
|
Thank you Enza.
|
|
| agree |
rhandler
9 horas
|
|
Thank you rhandler.
|
|
| agree |
Amilcar
18 horas
|
|
Thank you Amilcar.
|
|
| agree |
Rachel Fell
: comprehensively "the Product Licence/Marketing Authorisation Holder" acc. to MCA/Export Certificates (CPP Licensed)/April 2001 (the link too long/only seems to work if viewed as HTML not pdf)
3 dias 7 horas
|
|
Thank you, Rachel.
|
+2
10 minutos
António Ribeiro
Native in português
Professional in Oil & Gas Industry
Native in: português
Works in: inglês para português, português, português para inglês
Related KudoZ points
:
20
português term (edited):
Titular da Autoriza��o de Introdu��o no Mercado:
holder of the product licence (or, marketing authorisation)
Uma sugestão.
Peer comment(s):
| agree |
Muriel Vasconcellos
15 minutos
|
| agree |
Rachel Fell
: I think it's marketing authorisation holder more, but see my note in answer to Urico
3 dias 7 horas
|
9 horas
português term (edited):
autoriza��o de introdu��o no mercado
market approval
In U.S. pharmaceuticals, the term "market approval" is a common, unassuming term for this sort of thing.
Thus, "titular da autorização de introdução no mercado" would be "holder of market approval" or, even more idiomatically, "company with market approval".
Some online examples:
Treatment IND Update
Sponsor: Somerset Pharmaceuticals. Market Approval Date: June 5, 1989. Drug:
Pentostatin Treatment IND Granted: July 1988 Indication: Hairy cell leukemia ...
www.fda.gov/bbs/topics/ANSWERS/ANS00094.html
Project: An analysis of the pharmaceutical market system with ...
... for instance by directives concerning safety standards, the market approval
procedure of new pharmaceutical products, patent protection, post-marketing ...
www.onderzoekinformatie.nl/ nl/oi/nod/onderzoek/OND1259013/toon
BIO.COM: Biotechnology Pharmaceutical Market, Stocks, Finance ...
SGX Pharmaceuticals Receives Fast Track Designation for Troxatyl(TM) ... to seek
accelerated approval in which the FDA may grant market approval based on a ...
www.bio.com/industryanalysis/ industryanalysis_news.jhtml?cid=14100206
Good luck!
Thus, "titular da autorização de introdução no mercado" would be "holder of market approval" or, even more idiomatically, "company with market approval".
Some online examples:
Treatment IND Update
Sponsor: Somerset Pharmaceuticals. Market Approval Date: June 5, 1989. Drug:
Pentostatin Treatment IND Granted: July 1988 Indication: Hairy cell leukemia ...
www.fda.gov/bbs/topics/ANSWERS/ANS00094.html
Project: An analysis of the pharmaceutical market system with ...
... for instance by directives concerning safety standards, the market approval
procedure of new pharmaceutical products, patent protection, post-marketing ...
www.onderzoekinformatie.nl/ nl/oi/nod/onderzoek/OND1259013/toon
BIO.COM: Biotechnology Pharmaceutical Market, Stocks, Finance ...
SGX Pharmaceuticals Receives Fast Track Designation for Troxatyl(TM) ... to seek
accelerated approval in which the FDA may grant market approval based on a ...
www.bio.com/industryanalysis/ industryanalysis_news.jhtml?cid=14100206
Good luck!
Something went wrong...