검색어: fremstillingstilladelsen (덴마크어 - 영어)

- tilbagetrækning af fremstillingstilladelsen for et fremstillingssted«.
- withdrawal of the manufacturing authorization for a site of manufacture.`;

indehaver af fremstillingstilladelsen ansvarlig for batch frigivelse
manufacturing authorisation holder responsible for batch release

12 a indehaver af fremstillingstilladelsen ansvarlig for batch frigivelse
12 a manufacturing authorisation holder responsible for batch release

for at opnå fremstillingstilladelsen skal ansøgeren godtgøre, at han mindst opfylder følgende krav:
in order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:

fremstilleren sikrer, at alle fremstillingsprocesser gennemføres i overensstemmelse med god fremstillingspraksis og med fremstillingstilladelsen.
the manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorisation.

følgende oplysninger skal registreres for så vidt angår alle veterinærlægemidler, som indehaveren af fremstillingstilladelsen leverer:
the following information shall be recorded in respect of all veterinary medicinal products supplied by the holder of a manufacturing authorisation:

»1) - Ændring som følge af ændring(er) af fremstillingstilladelsen(-erne)
'1. - change following modifications(s) of the manufacturing authorization(s)

indehaveren af fremstillingstilladelsen sikrer, at hjælpestofferne er egnede til brug i lægemidler, ved at fastlægge, hvad der er passende god fremstillingspraksis.
the holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is.

efter anmodning fra fremstilleren, eksportøren eller et importerende tredjelands myndigheder attesterer medlemsstaterne, at en fremstiller af lægemidler er i besiddelse af fremstillingstilladelsen.
at the request of the manufacturer, the exporter or the authorities of an importing third country, member states shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization.

der påhviler yderligere indehaveren af fremstillingstilladelsen og de(n) kvalificerede person(er) et juridisk ansvar.
there are additional legal responsibilities for the holder of the manufacturing authorisation and for the qualified person(s).

efter anmodning fra fremstilleren eller eksportøren af veterinærlægemidler, eller myndighederne i et importtredjeland, skal medlemsstaterne attestere, at fremstilleren er i besiddelse af fremstillingstilladelsen.
at the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, member states shall certify that such manufacturer is in possession of the manufacturing authorization.

fremstillingstilladelse
manufacturing authorisation