EDQM FAQs
The QOS to be included in the CEP dossier should be prepared according to the provisions described in the Notice to Applicants for Medicinal Products for human use (Volume 2B – CTD Module 2.3). Please note that the QOS should be submitted in pdf format. To help applicants, a Word template for QOS can be found on the Certification web pages which should be converted into pdf when duly completed.