Vertaling van "requires the submission " (Nederlands → Frans) :

This is related to the entry into force of the royal decree of 14 December 2006, which requires the submission of a PSUR every three years compared with the limitation to just one RQ.
This is related to the entry into force of the royal decree of 14 December 2006, which requires the submission of a PSUR every three years compared with the limitation to just one RQ.

Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s
Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s

Selected projects awaiting regulatory decisions Completed submissions Product Indication US EU Japan News update ABF656 Hepatitis C Q4 2009 - Dossier for ABF656 at once-everytwo-weeks dosing was withdrawn in EU in April since additional information would be requested that could not be generated within required timeframe
Projets importants en attente de décisions réglementaires Demandes déposées Produit Indication USA UE Japon Mise à jour ABF656 Hépatite C T4 2009 - Le dossier d’ABF656 comportant une dose unique toutes les 2 semaines a été retiré de l’UE en avril, car l’information supplémentaire requise ne pouvait pas être fournie dans le délai imparti

As a result of this new requirement, the US submission of Menveo for use in infants is now expected in 2011.
Etant donné cette nouvelle exigence, le lancement de Menveo aux Etats-Unis pour son utilisation chez les enfants en bas âge est maintenant attendu en 2011.