Traduction de «application to authorise or extend » (Néerlandais → Français) :

Procedure regarding application to authorise or extend authorisation of a cell and tissue bank.
Procedure regarding application to authorise or extend authorisation of a cell and tissue bank.

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.
The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.
The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.

In view of the serious problems with the availability and effectiveness of MeSeA, FEDICT recommended, after examining the system, entrusting the application and infrastructure to an external partner who could solve the problems and extend the application with a portal for external partners.
In view of the serious problems with the availability and effectiveness of MeSeA, FEDICT recommended, after examining the system, entrusting the application and infrastructure to an external partner who could solve the problems and extend the application with a portal for external partners.

The Registration (marketing authorisation) department for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).
The Registration (marketing authorisation) department for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).

In addition to the daily activities (inspections, granting of licences/authorisations/certificates, RAS) the Production & Distribution Department also focused efforts in 2008 on gradually solving the backlog of Dutch language establishment applications and transfer applications for retail pharmacies. Additionally, the backlog in respect of raw materials used by retail pharmacies was also tackled.
In addition to the daily activities (inspections, granting of licences/authorisations/certificates, RAS) the Production & Distribution Department also focused efforts in 2008 on gradually solving the backlog of Dutch language establishment applications and transfer applications for retail pharmacies. Additionally, the backlog in respect of raw materials used by retail pharmacies was also tackled.

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.

The US FDA has extended its review of the supplemental New Drug Application for Zometa in the adjuvant (postsurgery) treatment of premenopausal women with early breast cancer in conjunction with hormonal therapy from the fourth quarter of 2010 to the first quarter of 2011.
Aux Etats-Unis, la FDA a prolongé du quatrième trimestre 2010 au premier trimestre 2011 son examen d’une autorisation supplémentaire de mise sur le marché (New Drug Application NDA) pour Zometa en conjonction avec un traitement hormonal chez les femmes préménopausées atteinte d’un cancer du sein à un stade précoce.