Englisch: abridged complexFranzösisch translation: procédure abrégée d\'AMM KudoZ The KudoZ network provides a framework for translators ... More |
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| Glossareintrag (aus Frage unten abgeleitet) | | Englisch Begriff oder Satz: | abridged complex | | Französisch Übersetzung: | procédure abrégée d\'AMM | | Eingetragen von: | Dr Jones |
| Optionen: - Zu diesem Eintrag beitragen |
Übersetzungen Englisch > Französisch [PRO] Medical - Medizin: Pharmazie / MA | | Englisch Begriff oder Satz: abridged complex | | ...this licence was an //abridged complex// of *******50mg tablets (PL 2345/678910 granted Minover 1856) |
| Dr JonesKudoZ-AktivitätFragen: 406 (alle geschlossen) Antworten: 946 Frankreich
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| Notiz(en) an den/des Fragesteller(s)François Begon: 9:41am Aug 11, 2007: cela semble concerner effectivement la mise sur le marché et les droits afférents, où il y a trois procédures : simple, standard et complexe.
Car "complex" demande à être traduit.
Voir google aux mts clés : abridged simple standard complex
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| | procédure abrégée d'AMM | Erklärung: "la société Sandoz, une autorisation de mise sur le marché pour la spécialité " amoxicilline/acide clavulanique Gnr-Développement 500 mg/62, 5 mg adultes comprimé pelliculé " selon la procédure dite abrégée du I, c), 3° de l'article R. 5133 du code de la santé publique"
http://www.rajf.org/imprimer.php3?id_article=3189
"Abridged products
The approval to market a medicinal product is based on the evaluation of scientific data provided by the company to support its quality, safety and efficacy. However, most of the 'new' products which come onto the market contain drugs which have been previously well tested and approved in other forms or for other companies. In these circumstances the European Directives (in particular Directive 2001/83EC) allow for what are known as 'abridged' applications so that companies do not have to unnecessarily repeat the tests and trials on animals and humans."
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&no... |
| Ausgewählte Antwort von:
FX Fraipont Belgien
| Hinweis von Fragesteller an den Antwortenden| 4 KudoZ-Punkte wurden für diese Antwort vergeben |
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1 Stunde Antwortsicherheit:   |
| procédure abrégée d'AMM
Erklärung: "la société Sandoz, une autorisation de mise sur le marché pour la spécialité " amoxicilline/acide clavulanique Gnr-Développement 500 mg/62, 5 mg adultes comprimé pelliculé " selon la procédure dite abrégée du I, c), 3° de l'article R. 5133 du code de la santé publique"
http://www.rajf.org/imprimer.php3?id_article=3189
"Abridged products
The approval to market a medicinal product is based on the evaluation of scientific data provided by the company to support its quality, safety and efficacy. However, most of the 'new' products which come onto the market contain drugs which have been previously well tested and approved in other forms or for other companies. In these circumstances the European Directives (in particular Directive 2001/83EC) allow for what are known as 'abridged' applications so that companies do not have to unnecessarily repeat the tests and trials on animals and humans."
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&no...
| FX Fraipont Belgien Muttersprache: Französisch PRO-Punkte in Kategorie: 43
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