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fremstillingstilladelse
manufacturing authorisation

dokumentation for en fremstillingstilladelse
proof of a manufacturing authorisation

indehaveren af en fremstillingstilladelse skal:
the holder of a manufacturing authorisation shall:

fremstillingstilladelse for import og eksport
manufacturing authorisation for import and export

fremstillingstilladelse ansvarlig for batch release
manufacturer responsible for batch release

indehaver af fremstillingstilladelse ansvarlig for batchfrigivelse
manufacturing authorisation holder(s) responsible for batch release

indehaveren af en fremstillingstilladelse skal have en kvalitetskontrolafdeling.
each holder of a manufacturing authorization should have a quality

indehaver af fremstillingstilladelse ansvarlig for batch release
manufacturing authorisation holder responsible for batch release

heri fastlægges de forpligtelser, der påhviler indehaveren af en fremstillingstilladelse.
it lays down the obligations of a manufacturing authorisation holder.

der kræves også fremstillingstilladelse for import fra og eksport til tredjelande.
the manufacturing authorisation shall also be required for imports from and exports to third countries.

en ansøgning om en fremstillingstilladelse skal mindst indeholde følgende oplysninger:
an application for a manufacturing authorisation shall contain at least the following information:

fremstillingstilladelse kræves, selv om de fremstillede lægemidler er bestemt til eksport.
this manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export.

3) eksport af lægemidler. i øjeblikket skal lægemiddelproducenter have en fremstillingstilladelse.
(i) immunological medicinal products; (ii) medicinal products derived from human blood; (iii) radiopharmaceuticals; (iv) generic products.

navn og adresse pÅ indehaver af markedfØringstilladelse og indehaver af fremstillingstilladelse ansvarlig for batch release.
name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

besiddelse af en fremstillingstilladelse giver ligeledes tilladelse til at forhandle de af denne tilladelse omfattede lægemidler en gros.
possession of a manufacturing authorization shall include authorization to distribute by wholesale the medicinal products covered by that authorization.

navn og adresse pÅ indehaveren af markedsfØringstilladelsen samt pÅ den indehaver af fremstillingstilladelse, som er ansvarlig for batchfrigivelse, hvis forskellig herfra
name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

(8) enhver aktør i forsyningskæden, der pakker lægemidler, skal være indehaver af en fremstillingstilladelse.
(8) any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorization.

en fremstillingstilladelse kan udstedes på betingelse af, at ansøgeren træffer foranstaltninger eller indfører særlige procedurer inden for en fastsat tidsfrist.
a manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period.

hvis lægemidlet er modtaget fra fremstilleren eller importøren, skal indehaveren af engrosforhandlingstilladelsen kontrollere, at fremstilleren eller importøren er indehaver af en fremstillingstilladelse.
where the medicinal product is obtained from the manufacturer or importer, wholesale distribution authorisation holders must verify that the manufacturer or importer holds a manufacturing authorisation.

hvis lægemidlet er aftaget fra fremstilleren eller importøren, skal indehaveren af engrosforhandlingstilladelsen kontrollere, at fremstilleren eller importøren er indehaver af en fremstillingstilladelse."
where the product is obtained from the manufacturer or importer, holders of the wholesale distribution authorisation must verify that the manufacturer or importer holds a manufacturing authorization.’