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March 2023

Zur Bewertung von Kombinationsarzneimitteln im Ramen der Arzneimittel-Zulassung

Journal/Book: Ärztezeitschrift für Naturheilverfahren. 1990; 31/2: 117-123.

Abstract: Since February 1st, 1987, the German Drug Law (AMG) implemented the fact that if a drug contains more than one medically active constituent it should be substained that every medically active constituent contributes to the positive judgement of the drug. Discussions are ongoing since then which kind of substantiation could be accepted. Different papers dealing with this issue such as the EC recommendation and the statements of the commission B 2 and commission E and the "basic criteria for the positive judgement of drug components" from Kemper/ Rietbrock are published up to now with different results. These papers are discussed and the different critera are enlightened with two examples. There is a strong need for a decision on the adequate substantiation criteria, otherwise many combination drugs will not survive the drug review being currently on its way in Germany.

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