BfArM - Federal Institute for Drugs and Medical Devices

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Template issued by the European Commission for the qualified person’s declaration on GMP comlpiance

Please note that the European Commission has issued a new “Template for the qualified person’s declaration equivalence to EU GMP for investigational medicinal products manufactured in third countries”. Sponsors are requested to use this new template for the qualified person’s declaration in their CTA application dossiers, as its use is mandatory from 30th October 2013.