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Maximum daily dose, route of administration and treatment duration are the only characteristics used by substance manufacturers to develop and justify the control strategy implemented and described in the CEP dossier. For substances for human use, this information should be based on human medicine European Public Assessment Report (EPAR), Summary of Product Characteristics (SmPC), or agreed literature such as Martindale as explained in the EDQM document New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0 (PA/PH/CEP (23) 21).

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