Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz, mit der die Leit-Ethikkommissions-Verordnung geändert wird
23. Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz, mit der die Leit-Ethikkommissions-Verordnung geändert wird
Auf Grund von § 41b Abs. 1 des Arzneimittelgesetzes, BGBl. Nr. 185/1983, zuletzt geändert durch BGBl. I Nr. 104/2019 und die Bundesministeriengesetz-Novelle 2020, BGBl. I Nr. 8/2020, wird verordnet:
Die Verordnung der Bundesministerin für Gesundheit und Frauen betreffend die besonderen Anforderungen an Ethikkommissionen im Rahmen von multizentrischen klinischen Prüfungen (Leit-Ethikkommissions-V), BGBl. II Nr. 214/2004, wird wie folgt geändert:
1. Der Kurzitel lautet ?Leit-Ethikkommissions-Verordnung?.
2. § 3 Abs. 1 zweiter Satz lautet:
?Diese ist dann gegeben, wenn die Ethikkommission ? oder ihre Rechtsvorgängerin ? seit mindestens drei Jahren besteht und in dieser Zeit eine größere Zahl von klinischen Prüfungen verschiedener Phasen...
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