OTC monograph systems

French translation: systèmes de monographies pour les médicaments en vente libre

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:OTC monograph systems
French translation:systèmes de monographies pour les médicaments en vente libre
Entered by: Yasmina Austin

08:21 Oct 15, 2010
English to French translations [PRO]
Law/Patents - Law: Patents, Trademarks, Copyright / Pharma.
English term or phrase: OTC monograph systems
FDA indicated that it would utilize a risk-based approach, giving priority to enforcement action involving new drugs that present direct challenges to a new drug approval and OTC monograph systems.
Thanks for your suggestions!!!!
Yasmina Austin
United Kingdom
Local time: 01:10
systèmes de monographies pour les médicaments en vente libre
Explanation:
"Pour vous donner une idée de l'efficacité de ce système de monographie, permettez-moi de vous dire que lorsque la loi sur les médicaments est entrée en vigueur en 1978, nous avions plus de 40 000 tisanes anciennes sur le marché allemand. Aujourd'hui, il en reste environ 20 000, qui sont couvertes par des autorisations standards de commercialisation. Ces 20 000 produits ne nécessitent aucune ressource à l'Institut, sauf une exception: nous devons mettre à jour les exigences d'étiquetage et d'autorisation standard. "
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Do...

"In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" obtain a New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. In order to deal with the vast number of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after review by expert panels. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings."
http://en.wikipedia.org/wiki/Over-the-counter_drug
Selected response from:

FX Fraipont (X)
Belgium
Local time: 02:10
Grading comment
Thanks ever so much!! This is just right.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3monographies des médicaments en ventre libre
Platary (X)
4systèmes de monographies pour les médicaments en vente libre
FX Fraipont (X)


Discussion entries: 1





  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
otc monograph systems
systèmes de monographies pour les médicaments en vente libre


Explanation:
"Pour vous donner une idée de l'efficacité de ce système de monographie, permettez-moi de vous dire que lorsque la loi sur les médicaments est entrée en vigueur en 1978, nous avions plus de 40 000 tisanes anciennes sur le marché allemand. Aujourd'hui, il en reste environ 20 000, qui sont couvertes par des autorisations standards de commercialisation. Ces 20 000 produits ne nécessitent aucune ressource à l'Institut, sauf une exception: nous devons mettre à jour les exigences d'étiquetage et d'autorisation standard. "
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Do...

"In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" obtain a New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. In order to deal with the vast number of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after review by expert panels. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings."
http://en.wikipedia.org/wiki/Over-the-counter_drug

FX Fraipont (X)
Belgium
Local time: 02:10
Native speaker of: Native in FrenchFrench
PRO pts in category: 176
Grading comment
Thanks ever so much!! This is just right.
Login to enter a peer comment (or grade)

19 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
otc monograph systems
monographies des médicaments en ventre libre


Explanation:
Propre aux États Unis ((over the counter).

--------------------------------------------------
Note added at 1 heure (2010-10-15 10:00:27 GMT)
--------------------------------------------------

VENTE, évidemment !!!


    Reference: http://www.senat.fr/rap/r96-196/r96-19682.html
Platary (X)
Local time: 02:10
Native speaker of: French
PRO pts in category: 11
Notes to answerer
Asker: Thanks so much for your help!!


Peer comments on this answer (and responses from the answerer)
agree  GILOU: To err is human..
1 hr
  -> Merci Gilles, jolie coquille de ma part :)))

agree  Thomas Rebotier: meme reaction ici ;) encore un traducteur qui travaille ventre à terre
1 hr
  -> Excellent Thomas et merci ! Si j'avais voulu le faire exprès, je n'aurais pas trouvé ni osé :))

agree  Beila Goldberg: ;-)
1 day 13 hrs
  -> Bonjour Beila et merci :)
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search