You searched for: authorisation (Danska - Tyska)

pre- authorisation
pre- authorisation

marketing authorisation suspended
arketing arketing

name of the marketing authorisation holder
name des pharmazeutischen unternehmers

advance authorisation scheme (aas) (forhåndstilladelsesordningen)
advance authorisation scheme („aas“) — vorabgenehmigungsregelung

dato for fØrste tilladelse / fornyelse af tilladelsen authorisation
datum der erteilung der zulassung/verlÄngerung der zulassung

the committee recommended that nexavar be given marketing authorisation.
bei gleichzeitiger einnahme anderer arzneimittel ist vorsicht geboten.

markedsføring (post authorisation safety study, pass) skal gennemføres for
datenanalyse erfolgen, durch die das nebenwirkungsprofil von telavancin im

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 beurteilung von humanarzneimitteln vor der zulassung

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

the holder of this marketing authorisation must inform the european commission about the marketing plans for the medicinal product authorised by the decision.
der inhaber dieser genehmigung für das inverkehrbringen muss die europäische kommission über die pläne für das inverkehrbringen des im rahmen dieser entscheidung genehmigten arzneimittels informieren.

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.

http://ec.europa.eu/food/plant/gmo/authorisation/index_en.htm.
http://ec.europa.eu/food/plant/gmo/authorisation/index_en.htm

det foreslåede system benævnes reach, som er akronym for registration, evaluation and authorisation of chemicals, dvs. registrering, vurdering og godkendelse af kemiske stoffer.
das vorgeschlagene system wird reach genannt, ein akronym für registration (registrierung), evaluation (bewertung) und authorisation (zulassung) von chemicals (chemikalien).

contribution to part s. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products
contribution to part s.2.3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma-derived medicinal products

4.5 en sikkerhedsundersøgelse efter tilladelse til markedsføring (post-authorisation safety study – pass) er en videnskabelig studie med fokus på lægemiddelsikkerhed.
4.5 eine sicherheitsstudie nach der zulassung (post-authorisation safety study – pass) ist eine wissenschaftliche studie, die der arzneimittelsicherheit dient.

det foreslåede system bygger hovedsageligt på reach - et integreret enhedssystem for registrering, vurdering og godkendelse af kemikalier (registration, evaluation and authorisation of chemicals).
ihr kernstück ist das reach-system, ein einheitliches integriertes system zur registrierung, bewertung und zulassung chemischer stoffe (registration, evaluation and authorisation of chemicals).