[Compassionate use of non-approved medicinal products. Legal basis and guidelines].
The inclusion of compassionate use in the 14th amendment to the German Medicines Act offers the possibility to treat patients with not yet licensed medicinal products outside of clinical trials. The prerequisite for compassionate use is that a marketing authorisation application has been submitted for the medicinal product or that clinical trials with the medicinal product are still ongoing. Additionally, the medicinal product shall be administered only to patients suffering from a seriously debilitating disease or whose disease is life-threatening, and who can not be treated satisfactorily with a licensed medicinal product. The paper outlines the legal basis and available guidelines and discusses further aspects which may be relevant in compassionate use programs.
Sudhop
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Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, 53175, Bonn. sudhop@bfarm.de