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In line with section 1.1.2.3 of the Ph. Eur. General Notices (Demonstration of suitability of monographs), applicants must demonstrate the suitability of the monograph for the quality control of their substance or medicinal product to the satisfaction of the competent authority. For more information, please consult the Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances, which is available on the EDQM website.