検索ワード: authorisation (オランダ語 - ドイツ語)

pre-authorisation
pre- authorisation

marketing authorisation suspended
matrixgekoppelte, kultivierte und charakterisierte, autologe chondrozyten

beoordeling ge- post-authorisation
post-authorisation

marketing authorisation number(s)
zulassungsnummer(n)

name of the marketing authorisation holder
name des pharmazeutischen unternehmers

(post-authorisation efficacy study, paes):
einschließlich beatmungsassoziierter pneumonien, bei hospitalisierten

name and address of the marketing authorisation holder
name und anschrift des pharmazeutischen unternehmers

notice to marketing authorisation holders – pharmacovigilance guidlines
notice to marketing authorisation holders – pharmacovigilance guidlines

non-interventional post-authorisation safety study (pass):
nichtinterventionelle unbedenklichkeitsprüfung nach der zulassung (pass): studie ac-052-516:

advance authorisation scheme (regeling voorafgaande vergunningen, „aas”)
advance authorisation scheme („aas“) — vorabgenehmigungsregelung

non-interventional post-authorisation safety study (pass) om de
nichtinterventionelle unbedenklichkeitsprüfung nach der zulassung (pass)

european medicines agency post-authorisation evaluation of medicines for human use
european medicines agency post-authorisation evaluation of medicines for human use

note for guidance on stability testing for a type ii variation to a marketing authorisation
note for guidance on stability testing for a type ii variation to a marketing authorisation

standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders

the european agency for the evaluation of medicinal products pre-authorisation evaluation of medicines for human use
the european agency for the evaluation of medicinal products pre-authorisation evaluation of medicines for human use

marketing authorisation holder merck sharp & dohme limited hertford road, hoddesdon hertfordshire en11 9bu verenigd koninkrijk
hertford road, hoddesdon hertfordshire en11 9bu vereinigtes königreich

carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products

use of near infra-red spectroscopy by the pharmaceutical industry and the data to be forwarded in part ii of the dossier for a marketing authorisation
use of near infra-red spectroscopy by the pharmaceutical industry and the data to be forwarded in part ii of the dossier for a marketing authorisation

position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.
position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.

na jaren voorbereiding is reach — registration, evaluation, authorisation and restriction of chemicals29— in juni in werking getreden.
nach jahrelanger vorbereitung wurde die reach-verordnung – über die registrierung, bewertung, zulassung und beschränkung chemischer stoffe29 – im juni endlich operativ.