The Ministry of Health and Women (Bundesministerium für Gesundheit und Frauen, BMGF) is the Competent Authority for Clinical trials for human medicines. The decision on an application is based on both the Gene Technology Act and the Pharmaceutical Product Act. As a consequence the advice of two advisory bodies, the Advisory Board for Biotechnology (Gentechnikkommission) and the Pharmaceutical Advisory Board (Arzneimittelbeirat) is taken into account. The applicant has to submit two different applications, one due to the Arzneimittelgesetz and the other due to the Gentechnikgesetz, but will receive a single permit fulfilling all obligations.

See also: The Austrian Network for Gene Therapy

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