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An assessment of genotoxicity is a precondition for marketing authorization respectively registration of herbal medicinal products (HMPs), as well as for inclusion into the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’ established by the European Commission in accordance with Directive 2001/83/EC as amended, and based...
The submission of data on genotoxicity is a precondition for marketing authorisation respectively registration of herbal medicinal products (HMPs) with well established or traditional use in some countries. In European regulatory guidelines prepared by the Committee on Herbal Medicinal Products (HMPC) of the European drug regulatory agency EMA, a test strategy is defined giving a pragmatic framework...
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