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Titular da Autorização de Introdução no Mercado:

English translation: Marketing approval holder (US)/Marketing authorization holder (UK)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Portuguese term or phrase:Titular da Autorização de Introdução no Mercado:
English translation:Marketing approval holder (US)/Marketing authorization holder (UK)
Entered by: Elizabeth Lyons
Options:
- Contribute to this entry
- Include in personal glossary

05:44 Oct 27, 2005
Portuguese to English translations [PRO]
Medical - Medical: Pharmaceuticals / Product labels - legal-style language
Portuguese term or phrase: Titular da Autorização de Introdução no Mercado:
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.
Elizabeth Lyons
United States
Local time: 17:44
(consent) holder of marketing approval/the approval for placing on the market (official EU trans.).
Explanation:
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...
Selected response from:

Hermann
Local time: 01:44
Grading 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.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +5Marketing authorisation holder
Andrés Martínez
3 +2holder of the product licence (or, marketing authorisation)António Ribeiro
3market approval
Todd Field
3(consent) holder of marketing approval/the approval for placing on the market (official EU trans.).
Hermann


  

Answers


9 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +5
Titular da Autorização de Introdução no Mercado:
Marketing authorisation holder


Explanation:

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

Andrés Martínez
Spain
Local time: 02:44
Specializes in field
Native speaker of: Spanish
PRO pts in category: 16

Peer comments on this answer (and responses from the answerer)
agree  Kathleen Goldsmith
6 hrs
  -> Thank you Kathleen.

agree  Enza Longo
6 hrs
  -> Thank you Enza.

agree  rhandler
9 hrs
  -> Thank you rhandler.

agree  Amilcar
18 hrs
  -> 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 days 7 hrs
  -> Thank you, Rachel.
Login to enter a peer comment (or grade)

10 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
Titular da Autorização de Introdução no Mercado:
holder of the product licence (or, marketing authorisation)


Explanation:
Uma sugestão.

António Ribeiro
Local time: 11:44
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 20

Peer comments on this answer (and responses from the answerer)
agree  Muriel Vasconcellos
15 mins

agree  Rachel Fell: I think it's marketing authorisation holder more, but see my note in answer to Urico
3 days 7 hrs
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
Titular da Autorização de Introdução no Mercado:
(consent) holder of marketing approval/the approval for placing on the market (official EU trans.).


Explanation:
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...


Hermann
Local time: 01:44
Native speaker of: Native in EnglishEnglish, Native in GermanGerman
PRO pts in category: 4
Grading 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.
Login to enter a peer comment (or grade)

9 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
autorização de introdução no mercado
market approval


Explanation:
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!

Todd Field
United States
Local time: 18:44
Native speaker of: Native in EnglishEnglish
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