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AMG Arzneimittelgesetz
Spezialisierungen
Medizinrecht
Der Antragsteller kann auf Unterlagen nach § 22 Absatz 2, 3 und 3c einschließlich der Sachverständigengutachten nach § 24 Absatz 1 Satz 2 eines früheren Antragstellers (Vorantragsteller) Bezug nehmen, sofern er die schriftliche Zustimmung des Vorantragstellers einschließlich dessen Bestätigung vorlegt, dass die Unterlagen, auf die Bezug genommen wird, die Anforderungen der Arzneimittelprüfrichtlinien nach § 26 erfüllen. Der Vorantragsteller hat sich auf eine Anfrage auf Zustimmung innerhalb einer Frist von drei Monaten zu äußern. Eine teilweise Bezugnahme ist nicht zulässig.
Quelle: BMJ
Import: