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1.1.7.1 Excipients

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The EMEA's CHMP was requested by the European Commission to provide an opinion on the risks associated with possible presence of carcinogens, mutagens, and substances toxic to health within excipients used as ingredients of medicinal products for human use. The CHMP published this opinion (in a joint paper from the QWP and SWP, published as EMEA/CHMP/SWP/146166/2007 on 18 October 2007) [13]. The conclusion of this evaluation was that the accumulated safety and pharmacovigilance data regarding well‐known, established, and standard excipients that meet EP requirements for quality served to provide a generally acceptable proof of acceptable safety and quality.

Mutagenic Impurities

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