검색어: mft (master file table) (덴마크어 - 영어)

mft (master file table)
master file table

master file for lægemiddelovervågningssystem
pharmacovigilance system master file

forsØgets master file og arkivering
the trial master file and archiving

mf hovedfil (dedikeret rodfil) (master file)
mf master file (root df)

european drug master file – revision
requirements for pharmaceutical documentation for pressurised metered dose inhalation products

master filen for lægemiddelovervågningssystemet
pharmacovigilance system master file

føre og på anmodning stille en master file for lægemiddelovervågningssystemet til rådighed
maintain and make available on request a pharmacovigilance system master file;

dokumentation vedrørende lokalerne skal være let tilgængelig i en site master file.
documentation relating to the premises should be readily available in a plant master file.

plasma master file'en evalueres videnskabeligt og teknisk af agenturet.
the plasma master file is subject to a scientific and technical evaluation carried out by the agency.

del iii vedrører de særlige krav til ansøgninger for biologiske lægemidler (plasma master file;
part iii deals with "particular application requirements" for biological medicinal products (plasma master file;

european drug master file procedure quality of modified release dosage forms for veterinary use
ich m4q questions and answers / location issues for common technical documents for the registration of pharmaceuticals for human use

tilgængelighed af og opbevaringssted for master filen for lægemiddelovervågningssystemet
availability and location of the pharmacovigilance system master file

kunne ikke afgøre master- filen for dette dokument.
could not determine the master file for this document.

dokumenterne i master filen for lægemiddelovervågningssystemet skal være fuldstændige og læselige.
pharmacovigilance system master file documents shall be complete and legible.

en henvisning til det sted, hvor master filen for lægemiddelovervågningssystemet opbevares«
a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.’,

af fremstilleren af det virksomme stof indgives direkte til de kompetente myndigheder i et separat dokument som en active substance master file.
to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an active substance master file.

european drug master file declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances:
industrymodified release oral and transdermal dosage formsrevision:european drug master filedeclaration of storage conditions for pharmaceutical veterinarymedicinal products in the product particulars and active substances:

indførelsen af en "master file for lægemiddelovervågningssystemet" for at sikre et stabilt, men ubureaukratisk tilsyn med virksomhedernes lægemiddelovervågningssystemer.
introduction of a "pharmacovigilance system master file" to ensure robust but un-bureaucratic oversight of companies pharmacovigilance systems;

agenturet kan til enhver tid anmode indehaveren af markedsføringstilladelsen om at forelægge en kopi af master filen for lægemiddelovervågningssystemet.
the agency may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.

med henblik herpå bør begrebet plasma master file (pmf) indføres, især for at samle den nationale ekspertise og for at opnå, at der gennem emea's koordinering kun skal foretages en enkelt bedømmelse.
to this end the concept of a plasma master file (pmf) should be introduced, in particular in order to allow the pooling of national expertise and through the coordination by the emea of a single evaluation.