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Traduction de «new complete applications were submitted » (Néerlandais → Français) :

In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.

In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.


In 2007 23 CP applications, including 1 new registration, were also started up with Belgium as (co)-rapporteur, and Belgium was RMS for 7 new registration applications via the DCP.

In 2007 23 CP applications, including 1 new registration, were also started up with Belgium as (co)-rapporteur, and Belgium was RMS for 7 new registration applications via the DCP.


Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.

Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.


Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.

Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.


Menveo, which was submitted in 2008 for US regulatory approval as a new vaccine to protect against four common types of meningococcal meningitis in people age 11-55, has received a Complete Response letter from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.

Menveo, a été soumis en 2008 aux autorités sanitaires américaines en vue d’obtenir son autorisation en tant que vaccin contre quatre types communs de méningite à méningocoques chez les personnes âgées de 11 à 55 ans. Ce médicament a reçu de la FDA une «Complete Response letter» demandant des informations complémentaires sur les sections Clinique et CMC (Chemistry Manufacturing and Control) du dossier.


Of the submitted applications, 95% were processed within the set time limits.

Of the submitted applications, 95% were processed within the set time limits.




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Date index: 2021-01-01
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