Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales, mit der die Verordnung betreffend Institute zur Chargenprüfung geändert wird
Auf Grund des § 26 Abs. 3 des Arzneimittelgesetzes, BGBl. Nr. 185/1983, zuletzt geändert durch das Bundesgesetz BGBl. I Nr. 78/1998, wird verordnet:
§ 1. Für die Chargenprüfung von Arzneispezialitäten zur Anwendung am Menschen gemäß § 26 des Arzneimittelgesetzes wird das Bundesinstitut für Arzneimittel, Wien, benannt.
§ 2. Für die Chargenprüfung von Arzneispezialitäten zur Anwendung am Tier gemäß § 26 des Arzneimittelgesetzes wird die Bundesanstalt für Tierseuchenbekämpfung, Mödling, benannt.
§ 3. (1) Stellt eines der in der Anlage 1  genannten Institute gemäß den für Chargenfreigaben innerhalb des Europäischen Wirtschaftsraumes einzuhaltenden Regelungen fest, daß die Charge einer Arzneispezialität zur Anwendung am Menschen der bei deren Zulassung in Österreich genehmigten Spezifikation und dem Stand der Wissenschaften entspricht, so ist die diesbezügliche Stellungnahme der
Äußerung des Institutes gemäß § 1 gleichzuhalten.
(2) Stellt eines der in der Anlage 2 genannten Institute gemäß den für Chargenfreigaben innerhalb des Europäischen Wirtschaftsraumes einzuhaltenden Regelungen fest, daß die Charge einer Arzneispezialität zur Anwendung am Tier der bei deren Zulassung in Österreich genehmigten Spezifikation und dem Stand der Wissenschaften entspricht, so ist die diesbezügliche Stellungnahme der
Äußerung des...
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