Traduction de «for which electronic submission » (Néerlandais → Français) :

The aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.
The aim has been to ensure the FAMHP’s continued ability to remain at the forefront of European countries for those aspects for which electronic submission becomes obligatory from 2009.

Op 22/02/2008 werd de 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' gepubliceerd op de EMEA website: [http ...]
Le document 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' a été publié sur le site de l’EMEA le 22/02/2008 : [http ...]

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

Optimisation of the integrated MeSeA system At the time of the FAMHP’s creation, the organisation had just one integrated system, MeSeA, to support its core business, i.e. the electronic submission of registration applications and variations for medicines for human use and the pharmacovigilance applications.
Optimisation of the integrated MeSeA system At the time of the FAMHP’s creation, the organisation had just one integrated system, MeSeA, to support its core business, i.e. the electronic submission of registration applications and variations for medicines for human use and the pharmacovigilance applications.

European procedures in which Belgium was acting as RMS or (co)-rapporteur ●● The switch from paper documents to electronic applications
European procedures in which Belgium was acting as RMS or (co)-rapporteur ●● The switch from paper documents to electronic applications

This strategy was presented and approved by the electronic helpdesk. A steering committee, which involves representatives of the CGG project, supervises the work.
Une commission d’experts – avec des représentants du projet CGG – encadre les travaux.

Submission for US regulatory approval, which had been anticipated in 2009, is now expected in 2012.
Attendu pour 2009, le dépôt d’une demande d’autorisation aux Etats-Unis est maintenant prévu en 2012.

Others include the first submission in Europe for MenB, which has the potential to become the first global vaccine against the B serogroup of meningococcal meningitis.
D’autres demandes comprennent la première soumission en Europe pour MenB qui est susceptible de devenir le premier vaccin au monde contre le sérogroupe B de la méningite à méningocoque.

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.

The US Food and Drug Administration granted these submissions priority review status, which accelerates the review of medicines that offer major advances or provide treatments where no adequate therapy exists.
En effet, la Food and Drug Administration (FDA) américaine leur a accordé le statut de revue prioritaire.