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AMG Arzneimittelgesetz
Spezialisierungen
Medizinrecht
Die zuständige Bundesoberbehörde kann bei Erfüllung ihrer Aufgaben nach diesem Gesetz ihr vorliegende Unterlagen mit Ausnahme der Unterlagen nach § 22 Abs. 1 Nr. 11, 14 und 15 sowie Abs. 2 Nr. 1 und des Gutachtens nach § 24 Abs. 1 Satz 2 Nr. 1 verwerten, sofern die erstmalige Zulassung des Arzneimittels in einem Mitgliedsstaat der Europäischen Union länger als acht Jahre zurückliegt oder ein Verfahren nach § 24c noch nicht abgeschlossen ist oder soweit nicht die §§ 24a und 24b speziellere Vorschriften für die Bezugnahme auf Unterlagen eines Vorantragstellers enthalten.
Quelle: BMJ
Import: