Vertaling van "evaluating new applications and requests for amendments " (Nederlands → Frans) :

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.

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.

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.

This agreement provides for an enhanced collaboration between the two institutions in the evaluation of quality data in applications for MA or associated amendments (variations) for vaccines for veterinary use, “Good Manufacturing Practices” inspection (GMP) and post-marketing reviews (monitoring by the FAMHP on samples taken).
This agreement provides for an enhanced collaboration between the two institutions in the evaluation of quality data in applications for MA or associated amendments (variations) for vaccines for veterinary use, “Good Manufacturing Practices” inspection (GMP) and post-marketing reviews (monitoring by the FAMHP on samples taken).