A. Clinical trials of medicines for human use falling under the revised German Medicinal Products Act (AMG)

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A. Clinical trials of medicines for human use falling under the revised German Medicinal Products Act (AMG)

I. As of midnight, 30 September 2005, this is no longer within the remit of the Charité EC. The relevant powers were transferred to the Berlin State Ethics Committee on 1 October 2005

On 30 September 2005, Charité EC lost its authorization for the review of clinical trials of investigational medicinal products under sections 40 - 42 of the AMG, following its amendment dated 30 July 2004, which came into effect on 6 August 2004. A new law, which came into effect on 1 October 2005, transferred legal competence for this type of ethical review to the ethics committee administered by the state government of Berlin. The new committee is referred to as the Berlin State Ethics Committee (Ethik-Kommission des Landes Berlin). Administrative responsibility rests with the Berlin State Department for Health and Social Affairs (LaGeSo).

All AMG research proposals which, between 6 August 2004 and 30 September 2005, were submitted to, and processed by, the Ethics Committee of the Faculty of Medicine of CharitéUniversitätsmedizin Berlin and the Berlin Chamber of Physicians, fall under these new regulations. Contact details for the Berlin State Ethics Committee are as follows: Landesamt für Gesundheit und Soziales BerlinGeschäftsstelle der Ethik-Kommission des Landes BerlinFehrbelliner Platz 110707 BerlinTel.: (030) 90229 - 1220 Fax: (030) 9028 - 3383 For further information:

Landesamt für Gesundheit und Soziales Berlin 
Geschäftsstelle der Ethik-Kommission des Landes Berlin
Turmstr. 21 Haus A
10559 Berlin

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