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Das europische Arzneimittelrecht

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Springer Nature
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N/A
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9783658172039
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Product Description

Im Fokus des Buches von Regina Krll steht die Analyse des gesamten Zulassungsverfahrens, vom Anwendungsbereich ber die Besonderheiten des Zulassungsantrages und den Verfahrensablauf bis zur Phase nach Erteilung der Zulassung. Beleuchtet werden auerdem die Entwicklung des europischen Arzneimittelrechts, die bertragung von Befugnissen an nachgeordnete Unionseinrichtungen sowie Rechtsgrundlagen, Aufbau und Arbeitsweise der Europischen Arzneimittelagentur, wobei auch der Problemkreis der Legitimitt, Unabhngigkeit und Transparenz thematisiert wird. Den Abschluss bilden Erwgungen zum Rechtsschutz.

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